MYLAN LABORATORIES LIMITED, UNIT - 7environmentclearance.nic.in/writereaddata/form-1/...Mylan...

MYLAN LABORATORIES LIMITED, UNIT - 7SY. NO. 14, 99 & 100, PHASE II, IDA,

PASHAMAILARAM VILLAGE, PATANCHERU MANDAL,MEDAK DISTRICT, ANDHRA PRADESH

FORM I

Project No. 1113-21-03November 2013

Mylan Laboratories Limited, Unit - 7Sy. No. 14, 99 & 100, Phase II, IDA,Pashamailaram (V), Patancheru (M),Medak (Dist.)- 502 307Phone: +91 040-3049 3876, 8008001511E-mail ID: [email protected]

STUDIES AND DOCUMENTATION BYTEAM Labs and ConsultantsB-115-117 & 509, Annapurna Block,Aditya Enclave, Ameerpet,Hyderabad-500 038.Phone: 040-23748 555/23748616,Telefax: 040-23748666

SUBMITTED TOMINISTRY OF ENVIRONMENT AND FORESTS,

GOVERNMENT OF INDIAPARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI

Mylan Laboratories Limited, Unit - 7

Form I Page 1

APPENDIX – I(See Paragraph – 6)

FORM I

I) Basic InformationS.No. Item Details

1 Name of the Project/s M/s Mylan Laboratories Limited, Unit - 72 S. No in the Schedule 5 f – A category3 Proposed capacity/area/length/tonnage

to be handled/command area/leasearea/number of wells to be drilled

Proposed to enhance the production capacity ofActive Pharma Ingredients (API’s) from 15.51 TPMto 81.52 TPM and addition of Co-Generationpower plant of 5 MW capacity.Cost of the project (Expansion): 40 Crores

4 New/Expansion/Modernization Expansion5 Existing Capacity/Area etc. Existing Capacity: 15.51 TPM

Area Existing: 30.81 Acres6 Category of Project i.e 'A' or 'B' “A”7 Does it attract the general condition? If

yes, please specifyYes.The Unit is Located in Notified Industrial Estate /Area.Critically Polluted Area of Pattancheru andBollaram are located at a distance of 5.5 KM’s fromthe Site.

8 Does it attract the Specific condition? Ifyes, please specify.

No

9 LocationPlot/Survey/Khasra No. Sy. No. 14, 99 & 100, IDAVillage Pashamylaram (V)Tehsil Pattancheru (M)District Medak DistrictState Andhra Pradesh

10 Nearest railway station/airport along withdistance in kms.

Nearest Railway Station is Lingampally at adistance of 20 KM from the site.

11 Nearest Town, City, District Headquartersalong with distance in kms.

Town & District HQ – Sangareddy - 24 KMCity - Hyderabad - 47.3 KM

12 Village Panchayats, Zilla Parishad,Municipal Corporation, Local body(complete postal address with telephonenos. to be given)

Pashamailaram Village


Form I Page 2

13 Name of the Applicant G. Srinivas Rao14 Registered Address Mylan Laboratories Limited, Unit – 7, Plot No 14, 99

& 100, Phase – 2, IDA, Pashamylaram (V),Pattancheru (M), Medak District – 502307

15 Address for Correspondence:Name G. Srinivas RaoDesignation(Owner/Partner/CEO) General Manger – EHSAddress Plot No 14, 99 & 100, Phase – 2, IDA,

Pashamylaram (V), Pattancheru (M),Medak District.

Pin Code 502307E-mail [email protected] Number Direct : 040-3049 3876

Mobile : +91 8008001511Fax No. +91 84 5522 4606

16 Details of alternative Sites examined, ifany. Location of these sites should beshown on a topo sheet.

-NA-

17 Interlinked Projects -NA-18 Whether separate application of

interlinked project has been submitted?No

19 If yes, date of submission20 If no, reason21 Whether the proposal involves

approval/clearance under: if yes, detailsof the same and their status to be given.(a) The Forest (Conservation) Act, 1980?(b) The Wildlife (Protection) Act, 1972?(c) The C.R.Z Notification, 1991?

-NA-

22 Whether there is any GovernmentOrder/Policy relevant/relating to the site?

No

23 Forest land involved (hectares) No24 Whether there is any location pending

against the project and /or land in whichthe project is propose to be set up?(a) Name of the Court(b) Case No(c) Orders/directions of the Court, if anyand its relevance with the proposedproject.

No Individual Court case against the Project.

However Green Tribunal Case, W.P. No. 19661 of2002 on the file of Hon’ble High Court of AndhraPradesh / Application No. 90 of 2013 before NGT isfiled against CETP Members.

(Presently our CETP Membership is limited toemergency usage as the plant has ZLD basedeffluent Treatment System)


Form I Page 3

(II) Activity

1. Construction, operation or decommissioning of the Project involving actions, which will causephysical changes in the locality (topography, land use, changes in water bodies, etc.)S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate quantities

/rates, wherever possible) with source ofinformation data

1.1 Permanent or temporary change inland use, land cover or topographyincluding increase in intensity ofland use (with respect to local landuse plan)

NO The proposal is for expansion of API’smanufacturing capacity in the existing unit.No additional land. Total Land area afterproposed expansion 30.81 Acres.

1.2 Clearance of existing land, vegetationand buildings?

NO Industrial

1.3 Creation of new land uses? NO1.4 Pre-construction investigations e.g.

bore houses, soil testing?YES Soil Testing completed

1.5 Construction works? YES Construction activity involves creation ofadditional utilities like Boiler, Chilling Plant etcand Co-Generation Power Plant.

1.6 Demolition works? NO

1.7 Temporary sites used forconstruction works or housing ofconstruction workers?

NO Construction labor from local villages shall beemployed.

1.8 Above ground buildings, structures orearthworks including linearstructures, cut and fill or excavations

YES Storage facilities shall be constructed. Nomajor cut and fill or excavation is anticipated.

1.9 Underground works including miningor tunneling?

NO

1.10 Reclamation works? NO1.11 Dredging? NO1.12 Offshore structures? NO1.13 Production and manufacturing

processes?YES Enclosed in Annexure – I

1.14 Facilities for storage of goods ormaterials?

NO Raw materials and solvents shall be storedwith safety precautions.

1.15 Facilities for treatment or disposal ofsolid waste or liquid effluents?

YES Solid waste shall be disposed to endusers/recyclers or sent to incineration.Effluent generated from the plant are treatedand reused. Details presented in Annexure II

1.16 Facilities for long term housing ofoperational workers?

NO Local people shall be employed.

1.17 New road, rail or sea traffic during NO


Form I Page 4

construction or operation?1.18 New road, rail, air waterborne or

other transport infrastructureincluding new or altered routes andstations, ports, airports etc?

NO

1.19 Closure or diversion of existingtransport routes or infrastructureleading to changes in trafficmovements?

NO

1.20 New or diverted transmission lines orpipelines?

NO

1.21 Impoundment, damming, culverting,realignment or other changes to thehydrology of watercourses oraquifers?

NO

1.22 Stream crossings? NO1.23 Abstraction or transfers of water

form ground or surface waters?YES Total water required shall increase from 257

KLD to 1166 KLD out of which 816 KLD shall bemet from APIIC and the balance shall berecycled water.

1.24 Changes in water bodies or the landsurface affecting drainage or run-off?

NO

1.25 Transport of personnel or materialsfor construction, operation ordecommissioning?

YES The construction material shall be drawn fromlocal sources within 10 – 15 km. There is notransport of personnel, as the constructionworkers shall be drawn from local villages.

1.26 Long-term dismantling ordecommissioning or restorationworks?

NO

1.27 Ongoing activity duringdecommissioning which could havean impact on the environment?

NO

1.28 Influx of people to an area in eithertemporarily or permanently?

YES The proposed project shall increase theemployment potential and hence may lead tomigration to surrounding villages.

1.29 Introduction of alien species? NO1.30 Loss of native species or genetic

diversity?NO

1.31 Any other actions? NO


Form I Page 5

2. Use of Natural resources for construction or operation of the Project (such as land, water, materialsor energy, especially any resources which are non-renewable or in short supply):S.No. Information/checklist confirmation Yes/No Details thereof (with approximate quantities

/rates, wherever possible) with source ofinformation data

2.1 Land especially undeveloped oragricultural land (ha)

NO Existing Unit

2.2 Water (expected source & competingusers) unit: KLD

YES Total water required shall increase from 257KLD to 1166 KLD out of which 816 KLD shall bemet from APIIC and the balance shall berecycled water.(Water Balance Enclosed in Annexure III)

2.3 Minerals (MT) NA2.4 Construction material – stone,

aggregates, sand / soil (expectedsource – MT)

YES Shall be sourced from the local villages.

2.5 Forests and timber (source – MT) NO2.6 Energy including electricity and fuels

(source, competing users) Unit: fuel(MT), energy (MW)

YES The required energy shall be drawn fromAPTRANSCO. Backup DG sets of 3 x 750, 1 x1250 and 2 x 1500 existing and 3 x 1500 KVAproposed, shall be provided to cater to energyrequirement during load shut downs. Theother energy source is Coal fired boilers of 8TPH, 5TPH FO fired boiler existing andproposed 30 TPH coal fired boiler to meet thesteam requirement both for co-generationand process. The required quantity of fuel(coal) is 120TPD and FO is 5 KLD. Diesel forStandby DG sets shall be 150 KL/month.

2.7 Any other natural resources (useappropriate standard units)

NA


Form I Page 6

3. Use, storage, transport, handling or production of substances or materials, which could beharmful to human health or the environment or raise concerns about actual or perceived risks tohuman health.S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities/rates, wherever possible) withsource of information data

3.1 Use of substances or materials, whichare hazardous (as per MSIHC rules) tohuman health or the environment(flora, fauna, and water supplies)

YES Solvents shall be used as reaction media.MSIHC rules shall be followed during storage,transportation and handling of raw materialsand hazardous chemicals.

3.2 Changes in occurrence of disease oraffect disease vectors (e.g. insect orwater borne diseases).

NO

3.3 Affect the welfare of people e.g. bychanging living conditions?

YES Shall increase the employment potential forlocals and affect the living conditions forbetterment.

3.4 Vulnerable groups of people whocould be affected by the project e.g.hospital patients, children, the elderlyetc.,

NO No sensitive receptors are present in theimmediate vicinity of the site. The projectshall not have any significant impact onvulnerable groups of people.

3.5 Any other causes NO

4. Production of solid wastes during construction or operation or decommissioning (MT/month)S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


4.1 Spoil, overburden or mine wastes NO4.2 Municipal waste (domestic and or

commercial wastes)NO Wastes from canteen, other commercial

wastes like paper, empty containers etc. Thecanteen wastes and commercial wastes shallbe in the range of 50 kg/day

4.3 Hazardous wastes (as per HazardousWaste Management Rules)

YES The quantity of hazardous waste generatedduring operation contain salts fromevaporators, stripper distillate, processresidue, and solvent residues, ETP sludge andfiltration media etc. enclosed in Annexure –IV

4.4 Other industrial process wastes YES Enclosed at Annexure IV4.5 Surplus product NO4.6 Sewage sludge or other sludge from

effluent treatmentYES Sludge from Effluent treatment plant and

Salts from MEE & ATFD shall be sent to TSDF.


Form I Page 7

4.7 Construction or demolition wastes YES Construction activity involves creation ofadditional utilities like Boiler, Chilling Plant etcand Co-Generation Power Plant.

4.8 Redundant machinery or equipment NO

4.9 Contaminated soils or other materials NO

4.10 Agricultural wastes NO

4.11 Other solid wastes NO Enclosed at Annexure IV

5. Release of pollutants or any hazardous, toxic or noxious substances to air (Kg/hr)S.No. Information/Checklist confirmation Yes/No Details thereof (with approximate


5.1 Emissions from combustion of fossilfuels from stationary or mobilesources

YES Coal and FO Shall be used as fuel. Quantity offuel and emissions details are enclosed inAnnexure V

5.2 Emissions from production processes YES Enclosed in Annexure - VI5.3 Emissions from materials handling

including storage or transportNO Material transfer takes place in closed

pipeline systems.5.4 Emissions from construction activities

including plant and equipmentYES Dust may rise during transport of material and

construction activity. The dust emissions shallbe mitigated by water spraying on the roadswithin the premises.

5.5 Dust or odors from handling ofmaterials including constructionmaterials, sewage and waste

YES Dust may rise during transport of material andconstruction activity. The dust emissions shallbe mitigated by water spraying on the roadswithin the premises.

5.6 Emissions from incineration of waste NO5.7 Emissions from burning of waste in

open air (e.g. slash materials,construction debris)

NO

5.8 Emissions from any other sources NO


Form I Page 8

6. Generation of Noise and Vibration, and Emissions of Light and Heat:S.No. Information/Checklist

confirmationYes/No Details thereof (with approximate

quantities/rates, wherever possible) with sourceof information data with source of informationdata

6.1 From operation of equipmente.g. engines, ventilation plant,crushers

YES Material transport and construction equipmentshall be source of noise, while transfer pumps,vacuum systems, DG sets are the sources of noiseduring operation.

6.2 From industrial or similarprocesses

YES From Turbine and DG sets, and controlled byproviding Acoustic Enclosures.

6.3 From construction or demolition YES Noise during construction shall be due toconstruction equipment and emergency DG sets.

6.4 From blasting or piling NO

6.5 From construction or operationaltraffic

NO The increased traffic shall not have any significantimpact.

6.6 From lighting or cooling systems NO

6.7 From any other sources NO

7.Risks of contamination of land or water from releases of pollutants into the ground or into sewers,surface waters, groundwater, coastal waters or the sea:S.No. Information/Checklist

confirmationYes/No Details thereof (with approximate

quantities/rates, wherever possible) with sourceof information data

7.1 From handling, storage, use orspillage of hazardous materials

NO All the hazardous materials will be stored in MSdrums, in a covered shed and no contamination ofsoil is expected

7.2 From discharge of sewage orother effluents to water or theland (expected mode and place ofdischarge)

NO All the wastes from domestic operations are sentto Biological treatment in “ZLD” system.

7.3 By deposition of pollutantsemitted to air into the land or intowater

NO All the emissions from process are controlled byproviding control equipment like scrubbers, DustCollectors and emissions from boiler shall becontrolled by providing bag filter.

7.4 From any other sources NO7.5 Is there a risk of long term build

up of pollutants in environmentfrom these sources?

NO


Form I Page 9

8.Risk of accidents during construction or operation of the Project, which could affect human health orthe environmentS.No. Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities/rates, whereverpossible) with source ofinformation data

8.1 From explosions, spillages, fires etc fromstorage, handling, use or production ofhazardous substances

YES All Inbuilt Safety precautions will beadopted and there will not be anydamage to environment or humanhealth

8.2 From any other causes NA8.3 Could the project be affected by natural

disasters causing environmental damage(e.g? Floods, earthquakes, landslides,cloudburst etc)?

NO

9.Factors which should be considered (such as consequential development) which could lead toenvironmental effects or the potential for cumulative impacts with other existing or plannedactivities in the localityS. No. Information/Checklist confirmation Yes/No Details thereof (with approximate

quantities/rates, whereverpossible) with source ofinformation data

9.1 Lead to development of supporting.facilities, ancillary development or

development stimulated by the project whichcould have impact on the environment e.g.:

• Supporting infrastructure (roads, powersupply, waste or waste water treatment, etc.)• housing development• extractive industries• supply industries• other

YES The project shall enhance the socioeconomic status of the area byincreasing the demand for housing,improving the employment. Thereare no major support industriesrequired for this plant.

9.2 Lead to after-use of the site, which couldhaven impact on the environment

NO

9.3 Set a precedent for later developments NO9.4 Have cumulative effects due to proximity to

other existing or planned projects with similareffects

NO The baseline environmental statusof the surrounding areas is withinthe prescribed limits as observedfrom the Secondary data.


Form I Page 10

(III) Environmental SensitivityS.No. Areas Name/

IdentityAerial distance (within 15 km.)Proposed project location boundary

1 Areas protected under internationalconventions, national or local legislation fortheir ecological, landscape, cultural or otherrelated value

NA

2 Areas which are important or sensitive forecological reasons - Wetlands, watercourses orother water bodies, coastal zone, biospheres,mountains, forests

YES Isnapur Cheru– North– 0.7 Km,Kotta Cheru – Northwest – 2.37 KmPedda Cheru – North – 4 KmLakdaram Cheru – North - 5.3 KmNakkavagu – Northeast – 6.2 Km

3 Areas used by protected, important or sensitivespecies of flora or fauna for breeding, nesting,foraging, resting, over wintering, migration

NA

4 Inland, coastal, marine or underground waters NO5 State, National boundaries NO6 Routes or facilities used by the public for access

to recreation or other tourist, pilgrim areasNO

7 Defense installations NO8 Densely populated or built-up area YES Isnapur is at a distance of 3.5 Km.9 Areas occupied by sensitive man-made land

uses (hospitals, schools, places of worship,community facilities)

NA 3.5 Km from the site

10 Areas containing important, high quality orscarce resources (ground water resources,surface resources, forestry, agriculture,fisheries, tourism, minerals)

NO

11 Areas already subjected to pollution orenvironmental damage. (those where existinglegal environmental standards are exceeded)

YES Patancheru and Bollaram Industrialareas at a distance of 5.5Km.

12 Areas susceptible to natural hazard whichcould cause the project to presentenvironmental problems (earthquakes,subsidence, landslides, erosion, flooding orextreme or adverse climatic conditions)

NO


Form I Page 11

(IV) Proposed Terms of Reference for EIA studiesScope of Work of EIA

“...The EIA shall cover the following:Description of the proposed project:The first task:” Description of the proposed project” forms a vital component of the EnvironmentalImpact Assessment (EIA) as it provides the basis for evaluating the likely causes of EnvironmentalImpacts.

Existing Environment and Baseline Conditions:The baseline assessment will be carried out to identify potentially sensitive and critical areas that may beaffected by the project in an area of 10 km surrounding the project location. The critical and sensitivetargets shall be plotted on land use map of project impact area. The existing environment and baselineconditions should be established from:-Analysis of existing information published and secondary data.-Consultation with relevant statutory authorities, and Field visits for supplementation of missing gaps.

The key subject areas which the EIA shall address include Ecology and Nature conservation, Air quality,surface and water quality in project impact area, soil quality, cultural heritage, landscape, land use, noisequality, etc. Natural habitats like national parks, wildlife reserves, sanctuaries, sacred grove, protectedareas, forests, wetlands, major rivers and waterways if any, shall also be identified and marked.

Assessment of Environmental Impacts:Based upon the results from the review of existing information, field visits, site data collection andconsultation, for each component of environment (physical, biological and socio economic) the positive,negative, direct and indirect, temporary and permanent impacts will be evaluated along with anindication of the degree of impact, i.e., whether the impact is significant, moderate, minor or negligible.The degree of impact shall also be quantified by using state of the art air quality impact prediction modelsbased on ISCST3 algorithms.

Environment Management Plan And Mitigation Plan:For each significant negative impact identified, specialist shall work closely with the engineeringteam/technical consultants to suggest practicable measures to avoid or mitigate the impact. Themitigation of environmental impacts will be by three mechanisms.=>Introduction of mitigation features through the engineering practices.=>Implementation of environmental controls during construction and operation.=>Legislative control involving compliance with Indian environmental laws.The Environmental management plan shall include an estimate of capital and recurring costs of mitigationmeasures and will identify the institutional framework for implementation.

Monitoring Plan:Having identified the significant environmental impact that is likely to arise as a result of the project, theproject team shall specify what monitoring is required during the various phases of the project cycle.The monitoring plan will identify parameters and frequency of monitoring and responsible organization.


Form I Page 12

I hereby give the undertaking that data and information given in the application and enclosures are trueto the best of my knowledge and belief and I am aware that if any part of the data and informationsubmitted is found to be false or misleading at any stage, the project will be rejected and clearancegiven, if any to the project will be revoked at our risk and cost.

Date:

Place:

Signature of the applicantWith Name and Full Address

(Project Proponent/Authorized Signatory)

M. G. Srinivas RaoGeneral Manager

Mylan Laboratories LimitedUnit – 7, Plot No 14, 99 & 100,

Phase – 2, IDA, Pashamylaram (V),Pattancheru (M),Medak District – 502307



ANNEXURES

SUBMITTED TOMINISTRY OF ENVIRONMENT AND FORESTS,

GOVERNMENT OF INDIAPARYAVARAN BHAVAN, LODHI ROAD, NEW DELHI

MylanLaboratoriesLimited,Unit‐7FormIAnnexures

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ANNEXURE - I M/s. Mylan Laboratories Limited, Unit – 7 obtained consent for establishment and

operation for Bulk Drugs & intermediates at Sy. No. 14, 99 & 100, Pashamailaram village,

Patancheru mandal, Medak district, Andhra Pradesh. It is proposed to expand the

manufacturing capacity of API’s with addition of 5MW Co-generation power plant. The

expansion entails a capital cost of Rs. 40 crores towards modernization of zero liquid

discharge facility, debottlenecking by way of incorporating the advanced technology. and

state of the art equipment. Manufacturing capacity is presented in Table A-1. The

proposed manufacturing capacity is presented in Table A-2.

Table A-1 Manufacturing Capacity – Permitted

S.No Name of the Product Quantity TPM Kg/day

Regular Products 1 Acyclovir 8 266.67 2 Valacyclovir 1.5 50.00 3 Amlodipine Besilate 2 66.67 4 Clarithromycin 1.5 50.00 5 Loratadine 1 33.33 6 Lansaprazole 0.83 27.67 7 Cetrizine 0.1 3.33

Total -I 14.93 497.67 Campaign Products

1 Fluconazole 0.17 5.67 2 Losartan 0.17 5.67 3 Omeprazole 0.04 1.33 4 Itraconazole 0.04 1.33 5 Terbinafine HCl 0.08 2.67 6 Lisinopril 0.08 2.67 7 Perindopril 0.04 1.33 8 Atorvastatin 0.04 1.33 9 Almotriptan 0.04 1.33

10 Zoledromic Acid 0.04 1.33 11 Des-Loratidine 0.08 2.67 12 Alprazolam 0.08 2.67 13 Lamotrigene 0.17 5.67 14 Resperidone 0.08 2.67 15 Rizatriptan 0.04 1.33 16 Labetelol 0.08 2.67 17 Zolmitriptan 0.04 1.33

Total – II (Worst case any 4) 0.58 19.33 Grand Total (I+II) 15.51 517


Page 4

Table A-2 Manufacturing Capacity – After Expansion

S.No Name of the Product Quantity TPM Kg/day

1 Acyclovir 30 1000 2 Aliskiren Hemifumarate 0.1 3.33 3 Almotriptan 0.1 3.33 4 Alprazolam 0.2 6.67 5 Amlodipine Besilate 1 33.33 6 Armodafinil 0.04 1.33 7 Asenapine Maleate 0.1 3.33 8 Atorvastatin 0.01 0.33 9 Azelnidipine 0.02 0.67

10 Azilsartan Medomoximil 0.02 0.67 11 Cetrizine 1 33.33 12 Clarithromycin 4 133.33 13 Cyclobenzaprine 0.11 3.67 14 Des Venlafaxine Fumarate 0.03 1 15 Des-Loratadine 0.1 3.33 16 Dexalansoprozol 0.5 16.67 17 Dronedarone 0.08 2.67 18 Fluconazole 1 33.33 19 Irbesetran 8 266.67 20 Itraconazole 0.05 1.67 21 Labetelol 0.02 0.67 22 Lamotrigene 0.25 8.33 23 Lansaprazole 1 33.33 24 Lisinopril 0.01 0.33 25 llapprazole Sulfide 0.08 2.67 26 lloperidone 0.02 0.67 27 Loratadine 1 33.33 28 Losartan 1 33.33 29 O-Des methyl Venlafaine Succinate 0.03 1 30 Omeprazole 0.03 1 31 Oxybutynim H CL 0.05 1.67 32 Paliperidone 0.03 1 33 Perindopril Arginine 0.03 1 34 Perindropil Erbumine 0.05 1.67 35 Pioglitazone 3 100 36 Pitavastatin 0.1 3.33 37 Rebeprazole 0.15 5 38 Resperidone 0.15 5 39 Rizatriptan 0.1 3.33 40 Rosuvastatin 0.2 6.67 41 Telmesetran 2 66.67 42 Temazepam 0.01 0.33


Page 5

43 Terbinafine HCl 0.02 0.67 44 Tetrabenazine 0.02 0.67 45 Valacyclovir 25 833.33 46 Zoledronic Acid 0.01 0.33 47 Zolmitriptan 0.1 3.33 48 Validation products 0.6 20 Total 81.52 2717.33 Co-Generation Power Plant 5 MW

List of By-Products (Tentative)

S.No Name of the Byproduct Quantity (Kg/day)

Name of the Product

1 1,3 Di Cyclo Hexyl Urea 1000 Valacyclovir


Page 6

Process Description of Acyclovir

Chemical Reaction of Acyclovir

PT SA

(CH3CO)2O

1,3-DIOXOLANE

O O

SODIUM ACET AT E

(CH3CO)2O

CH3CO-O-CH2-O-CH2CH2-O-COCH3

DIOXOLANE DIACETATE

CH3CO-O-CH2-O-CH2CH2-O-COCH3

DIOXOLANE DIACETATE

DMA

[H2O]

HN

N

O

H2N

N

NH

GUANINE

PT SA

T OLUENE

CH2OCH2CH2OAC

HN

N

O

CH3COHN

N

N

DIACETYL ACYCLOVIR

HN

N

O

CH3COHN

N

N

DIACETYL GUANINE

COCH3

HN

N

O

CH3COHN

N

N

DIACETYL GUANINE

COCH3

Process Description for Acyclovir

Guanine is reacted with acetic anhydride to form diacetyl guanine. Diacetyl guanine is

condensed with dioxolane diacetate for form stage II product. Stage II product is

hydrolysed under basic conditions to give crude Acyclovir. Crude Acyclovir is

purified with water to give Acyclovir. The process flow diagram is presented in Fig

A-1 and material balance is presented in Table A-3.


Page 7

Guanine Diacetayl Guanine Acetic anhydride

PTSA Recoveries(-)Acetone Stage - I Acetone

Acetic anhydride Organic Resiude

Diacetayl Guanine Diacetyl acyclovir Dioxolane Diacetate Crude 2 nd crop

Toluene Recoveries(-)PTSA Stage - II Toluene

Acetone Acetone

Organic residue

Diacetyl acyclovir Acyclovir Crude DMA 2nd crop

Water Waste WaterAcetone

Stage - III Recoveries(-)DMAAcetone

Organic residue

Acyclovir Crude Water 2nd crop

Carbon Waste WaterHyflo Recoveries(-)

Sodium Diothionite (hydrose ) Stage - IV Acetone Acetone Organic residue

Spent carbon

Acyclovir

Process Flow Sheet - Acyclovir

Fig A-1 Process Flow Diagram of Acyclovir


Page 8

Table A-3 Material Balance for Acyclovir Stage: I

Input Output S.No Name of the Material Per Batch Name of the Material Per Batch

Kgs Kgs 1 Guanine 114 Diacetayl Guanine 162 2 Acetic anhydride 463.70 3 PTSA 4.55 Waste Water 0 4 Acetone 170.86

Solid Waste Recoveries(-) Organic Resiude 103.10 Acetone 162 Organic waste Acetic anhydride 325 Spent carbon Emissions Acetone 1 Total 265.88 265.9

Stage: II


Kgs Kgs 1 Diacetayl Guanine 162 Diacetyl acyclovir 166 2 Dioxolane Diacetate 224 Crude 2 nd crop 219.8 3 Toluene 571 Waste Water 0.00 4 PTSA 8 5 Acetone 197

Solid Waste Organic residue 34.55 Spent carbon 0 Recoveries(-) Toluene 542.49 Acetone 186.9 Emissions Toluene 2.86 Acetone 0.98 Total 424.44 424.44


Page 9

Stage: III


Kgs Kgs 1Diacetyl acyclovir 166 Acyclovir Crude 121 2DMA 296 2nd crop 44 3Water 166 Waste Water 166.2 4Acetone 131 DMA 5.92

Acetone 0.7 Solid Waste Organic residue 13.52 Spent carbon 0.0 Recoveries(-) Emissions DMA 281.1 DMA 1.48 Acetone 124.6 Acetone 0.66 Total 353.77 353.77

Stage: IV


Kgs Kgs 1Acyclovir Crude 121 Acyclovir 100 2Water 4510 2nd crop 21 3Carbon 71.78 Waste Water 4509.83 4Hyflo 14.4 Acetone 3.84 5Sodium Diothionite (hydrose ) 2 Sodium compound 0.5 6Acetone 192

Solid Waste Recoveries(-) Organic residue 6.53 Acetone 183 Spent carbon 86 Emissions Acetone 0.96 Total 4729.22 4729.22


Page 10

ANNEXURE – II: Wastewater Treatment Facilities

The effluent generated from the proposed expansion of M/s. Mylan Laboratories Limited,

Unit – 7 is mainly from process, washings, scrubbers, cooling towers & boiler blow downs

and domestic effluent. Effluent from process, HTDS effluent sent to Stripper, Multiple

Effect Evaporator followed by ATFD, Biological treatment and RO. LTDS effluent from

process, washings, scrubbers, Solvent recovery system, DM rejects, Cooling towers, boiler

bow downs, detoxification effluent, ZLD washings and domestic effluents shall be sent to

Biological treatment system followed by RO. The treated effluent shall be reused for

cooling towers. Total Effluent generated and mode of treatment before and after

expansion is presented in Table A-4 and quantity and quality of effluent generated from

process after expansion is presented in Table A-5.

Table A-4 Quantity of Effluent Generated – After Expansion (Tentative)

Description of Effluent Quantity (KLD) Mode of Final Disposal Permitted After

Expansion HTDS Effluents

Process 42 75 Treated in effluent treatment plant consist of Stripper, MEE, ATFD and Biological treatment followed by RO.

RO Permeate reused for cooling tower makeup and RO rejects sent to MEE.

Total HTDS 42 67 LTDS Effluents

Process Effluent 12 72 Biological treatment followed by RO. RO Permeate reused for cooling tower makeup and RO rejects sent to MEE.

Washings Effluent 10 Scrubber Effluent 5 Solvent recovery plant 10 Boiler 42 20 Cooling Tower 72 DM Plant, Softener & Purified water system

35

Detoxification 5 ZLD Washings 10 Domestic 15 40 Total LTDS 111 279


Page 11

Table A-5 Quantity and Quality of Effluent Generated from Process (Tentative)

Waste Water Segregation - (Criteria: TDS < 5000 mg/lt.) LTDS Effluents HTDS Effluents

S.No Description Quantity Ltrs

COD KGD

COD mg/l

TDS KGD

TDS mg/l

Quantity Ltrs

COD KGD

COD mg/l

TDS KGD

TDS mg/l

1 Acyclovir 38625 112.53 2913 4.12 107 0 0 0 0 2 Valacyclovir 30238 433.84 14347 0 0 8499 568.09 66844 48.33 5687 3 Amlodipine Besilate 954 36.67 38413 0 0 0 0 0 0 4 Clarithromycin 0 0 0 0 0 5848 213.4 36491 150.32 25704 5 Loratadine 0 0 0 0 0 4269 192.18 45022 365.68 85668 6 Lansaprazole 820 57.63 70253 0 0 3732 57.14 15310 136.63 36610 7 Cetrizine 0 0 0 0 0 2713 130.42 48064 146.02 53813 8 Fluconazole 0 0 0 0 0 2317 146.83 63361 100.33 43295 9 Losartan 0 0 0 0 0 1670 69.07 41355 83.58 50047

10 Telmesetran 0 0 0 0 0 1582 57.47 35350 43.86 26974 11 Irbesartan 0 0 0 0 0 3934 126.5 31475 85.2 21199 12 Omeprazole 19 0.21 11048 0.06 3107 69 2.82 40777 2.07 29949 13 Itraconazole 2 0.77 331819 0 0 36 0.51 14116 1.01 27723 14 Terbinafine HCl 0 0 0 0 0 29 0.77 26718 1.94 67044 15 Lisinopril 6 0.07 11657 0 0 128 2.09 16310 2.73 21342 16 Perindopril Arginine 13 1.55 115702 0 0 49 3.62 73363 2.9 58795 17 Atorvastatin 0 0 0 0 0 16 0.47 28467 0.42 25650 18 Almotriptan 0 0 0 0 0 908 28.39 31251 60.09 66154 19 Zoledronic Acid 10 0.02 1691 0 0 9 0.5 53048 1.02 107736 20 Des-Loratadine 0 0 0 0 0 228 3.75 16453 3.33 14638 21 Alprazolam 250 11.97 47856 0 0 346 8.87 25656 18.38 53145 22 Lamotrigene 0 0 0 0 0 1005 16.27 16195 26.73 26608 23 Resperidone 0 0 0 0 0 186 3.52 18943 11.65 62748 24 Rizatriptan 0 0 0 0 0 1111 91.02 81904 115.3 103757 25 Labetelol 0 0 0 0 0 29 2.48 85939 0.57 19873 26 Zolmitriptan 14 1.2 86687 0 0 640 18.07 28219 33.78 52754


Page 12

27 Pitavastatin 329 2.07 6286 1.33 4047 1018 47.71 46866 55.08 54114 28 lloperidone 0 0 0 0 0 7.3 0.08 10829 0.35 47615 29 Azelnidipine 0 0.02 38961 0 0 4 1.09 270789 0.11 27227 30 Rebeprazole 0 0 0 0 0 439 7.88 17956 67.23 153291 31 Dexalansoprozol 17 5.73 335179 0.05 3119 4111 329.04 80034 120.91 29410 32 Rosuvastatin 0 0 0 0 0 2506 59.04 23559 137.51 54868 33 Oxybutynim H CL 22 0.76 34164 0 0 73 7.8 106294 10.85 147836 34 Pioglitazone 0 0 0 0 0 20128 501.12 24896 1150.18 57142 35 Paliperidone 0 0 0 0 0 47 1.84 39541 6.38 137064 36 O-Des methyl

Venlafaine Succinate 0 0 0 0 0 86 4.24 49058 6.56 75998

37 Cyclobenzaprine 3 0.27 94340 0 0 71 1.1 15390 13.41 188159 38 Armodafinil 259 4.34 16727 0 0 222 13.19 59518 10.96 49470 39 llapprazole Sulfide 0 0 0 0 0 599 41.39 69094 12.64 21100 40 Dronedarone 0 0 0 0 0 99 2.46 24821 2.78 28067 41 Des Venlafaxine

Fumarate 0 0 0 0 0 1454.4 87.19 59949 108.93 74894

42 Temazepam 0.4 0.01 11224 0 1202 14.3 0.23 15776 0.6 41945 43 Perindropil Erbumine 0 0 0 0 0 38.4 1.55 40301 2.31 60157 44 Asenapine Maleate 0 0 0 0 0 4315.9 78.88 18277 1203.88 278940 45 Tetrabenazine 0 0 0 0 0 22.7 2.41 106070 4.84 212824 46 Aliskiren

Hemifumarate 0 0 0 0 0 79.2 3.47 43814 2.01 25320

47 Azilsartan Medomoximil

0 0 0 0 0 11.9 0.27 22308 0.37 30776


Page 13

ANNEXURE – III: Water Balance

The total water requirement shall increased from 257 KLD to 1175 KLD after expansion

out of which 821 KLD shall be drawn from APIIC and balance shall be recycled water. The

water balance for daily consumption after expansion is presented in Table A-6.

Table A-6 Total Water Balance – After Expansion (Tentative)

Purpose INPUT (KLD) OUTPUT (KLD) Fresh Water

Recycled Water

Loss Wastewater

Process 138 147* Washings 10 10 Scrubber 5 5 Solvent recovery plant 10 10 Boiler 216 196 20 Process & Utility RO rejects to Cooling tower make-up

196 354 580 72

Cooling Tower 106 DM Plant, Softener & Purified water system

35 35

Detoxification 5 5 ZLD Washings 10 10 Water for gardening 50 50 Domestic 40 40 Gross Total 821 354 826 354 Total 1175 1180

* Process effluents contain soluble raw materials, byproducts, solvents etc.


Page 14

ANNEXURE – IV: Solid Waste

Solid wastes are generated from the process shall be sent to TSDF/ Cement Industries for

Co-incineration. Stripper distillate shall send to TSDF/ Cement Industries for Co-

incineration. Evaporation salts from MEE and ATFD and ETP Sludge shall be sent to

TSDF. The total solid waste generated and mode of disposal is presented in Table A-7.

Table A-7 Solid Waste Details – After Expansion (Tentative) S.No. Description of waste UOM Permitted After

Expansion Disposal Point

1.Hazardous Waste with Disposal Option : 1 Spent Carbon TPM 15 45 TSDF for incineration /

Cement Industry for co-incineration

2 Process Organic Waste TPM 37.65 70 3 Distillation Bottom Residue TPM 22.5 195 4 Spent Mixed Solvents (Colored) KL/Month 300 5 Stripper Distillate KL/Month 45 6 Process Inorganic Salts TPM 12.39 25 TSDF for secure Landfill 7 ETP Sludge TPM 30 65 8 Forced Evaporation Salts TPM 20.61 132 9 Thermocol TPM 10 10 Insulation Waste TPM 10 11 Off specified & Discarded Raw

materials, lab chemicals & products

TPM 2

12 Used Filters (HEPA, Oil Filters etc.)

No's / Month

20

13 Discarded PPE, Shoe covers, Lab vials, tissue papers etc...

TPM 5

14 DM Plant & Softner Plant Resins TPM 2 15 Laboratory vials / Injection Vials Kgs /

Month 100 TSDF for incineration

16 By-products TPM 0 45 Sale to Preprocessors 2.Hazardous Waste with Recycling Option :

17 Used Oil / Waste Lubricating oil Ltrs/Month 900 3000 Authorized recyclers

18

Detoxified Container No/month 300 3000 Sale after detoxification Glass Bottles Nos/

Month 0 500

Detoxified Liners TPM 30 19 Spent Mixed Solvents /

Recovered Solvents (Colorless) KL/Month 450 450 Sale to authorized

recyclers 20 Lead acid batteries No/year 75 Authorized recyclers 21 Electrical & Electronic Waste (E -

Waste) TPA 15 Authorized Off - Site

facility


Page 15

Non Hazardous Solid Waste 22 Coal Ash TPM 1000 Brick Kilns 23 Paper waste TPM 10 Sale to recyclers 24 Wood waste , carton boxes TPM 10 Sale to recyclers 25 Packing materials TPM 25 Sale to recyclers 26 Broken glass TPM 5 Sale to recyclers 27 Metal scrap (MS/GI/SS etc...) TPM 25 After detoxification to

sale 28 Canteen waste TPM 5 Composting at site /

Piggeries


Page 16

ANNEXURE – V: Stack Emissions Details

The sources of air pollution in the plant are from the existing 8 TPH Coal fired boiler,

5TPH FO fired boiler and proposed 30 TPH coal fired boiler to meet the steam

requirement both for co-generation and process and existing backup DG sets of 3 x 750, 1 x

1250 and 2 x 1500 and proposed 3 x 1500 KVA, to cater to energy requirement during load

shut downs. The proposed air pollution control equipment for coal fired boiler is bag

filter. DG sets shall be provided with stack heights based on the CPCB formula for

effective stack height. The emission rates of SPM, SO2, NOx and SPM from each stack are

presented in Table A-8.

Table A-8 Stack Emission Details

S. No

Stack Connected to

Stack Ht (m)

Dia of stack at top(m)

Temp. of exhaust

gases (0C)

Exit Velocity (m/sec)

Pollutant Emission Rate

(g/sec) SPM SO2 NOx

Permitted 1 8TPH Coal fired

Boiler* 30 1.5 130 6.05 0.6 0.7 0.25

2 5 TPH FO fired Boiler*

30 1.5 146 5.57 0.09 0.33 0.17

3 3 x 750KVA DG Sets**

8.5 0.2 165 6.2 0.01 0.02 0.03

4 1 x 1250KVA DG Set**

11 0.2 180 8.8 0.01 0.03 0.04


12 0.2 151 10 0.02 0.03 0.05

Proposed 1 30TPH Coal

Fired Boiler 42 2.0 200 15 2.5 4.5 5.1


12 0.2 151 10 0.02 0.03 0.04

*Boilers shall be kept as standby **DG sets will be used during load shut down by APTRANSCO.


Page 17

ANNEXURE – VI: Process Emissions Details

Table A-9 Quantity of Process Emission Generated and Mode of Treatment/Disposal (Tentative)

S.No. Name of product Stage Name of the gas Quantity (Kg/day)

Treatment/Disposal

1 Valacyclovir II Hydrogen 1296 Latout into atmosphere through water column

2 Clarithromycin I Carbondioxide 3.3 Latout into atmosphere safely

3 Loratadine I Hydrogen Chloride

22 Sent to Scrubber

4 Omeprazole I Hydrogen Chloride

0.42 Sent to Scrubber

5 Lisinopril I Carbondioxide 0.22 Latout into atmosphere safely

I Hydrogen 0.07 Latout into atmosphere through water column

6 Perindopril Arginine

II Hydrogen 0.56 Latout into atmosphere through water column

7 Atorvastatin I Carbondioxide 0.03 Latout into atmosphere safely

8 Almotriptan II Carbondioxide 2.5 Latout into atmosphere safely

III Carbondioxide 3.33 Latout into atmosphere safely

9 Lamotrigene II Carbondioxide 8.33 Latout into atmosphere safely

10 Rizatriptan II Hydrogen 0.83 Latout into atmosphere through water column

11 Labetelol II Hydrogen 0.2 Latout into atmosphere through water column

12 Rosuvastatin I Carbondioxide 3.33 Latout into atmosphere safely

13 Paliperidone II Carbondioxide 0.83 Latout into atmosphere safely

14 Dronedarone I Carbondioxide 0.37 Latout into atmosphere safely



STUDIES AND DOCUMENTATION BYTEAM Labs and ConsultantsQCI: MoE&F OM, List A-1, S.No. 150.(An ISO 9001:2008, ISO 14001:2004 &OHSAS 18001:2007 Certified Organization)B-115, Annapurna Block, Aditya EnclaveAmeerpet, Hyderabad-500 038.Phone: 040-23748 555/616,Telefax: 040-23748666Email: [email protected]

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