Mehta API Pvt. Ltd - Research, Process Development ...€¦ · property development, Strategic...

focusing on green & sustainable technology…

Contributing to Good Health for Good Life

MANAGEMENT TEAM

Mr. DEVENDRA H MEHTA is a CEO,his focus on Business Development,In/Out licensing, Intellectualproperty development, Strategicalliances, Eco friendly technology,with 25 years of rich experience.

Mr. HARSHADRAI MEHTA , is aCMD. He is the founder ofMehta Group. With over fivedecades of dedicated work anda wealth of experience in theAPI Manufacturing field. He isthe driving force behind MAPL’ssuccess & mentoring 2ndgeneration for successfulgrowth.

Mr. YOGIN H MEHTA is a COO ;He has 24 years of richexperience in Plant operation,Strength is execution , adoptingnew technologies continuousimprovement in operating cost ,capacity enhancement with helpof team, laying emphasis on ecofriendly technology & qualitycompliance.


CORPORATE OVERVIEW

Vision

• To make people smile bycontributing to better health

• Contributing to Good Health forGood Life.

Core Values• Integrity• Transparency • Proactively manage change• Develop entrepreneurs through an achievement‐oriented culture

• Build an education savvy business environment

• Share knowledge and focus on end results

Mission

• Eco – friendly and go‐green culture integrating with excellenttechnology, development andmanufacturing

• Customer Centric Approach• Competent Team for managementand execution

• Supplier Development• CGMP Facility.

Core CultureWebelieve in an environment that:• promotes performance• nurtures team work• strengthens quality consciousness• encourages transparencies• facilitates professional growth


MEHTA APIEU‐GMP, EDQM, TGA, WHO ‐GMP

Serving Since 1970Manufacturing APIs, HAPIs, Advanced intermediates

3‐ Process Patent Filed

More in Pipeline

In Regulated Market since 2003

2‐ CEP2 ‐CEP Filed 12‐EDMF Filed (30 Countries) 4‐ Under Pipeline .

Export products in more than 40 countries

Spanning 6 Continents

Manufacturing CapacityBlock A ‐ Tonnage Block B ‐ MediumBlock C – SmallBlock D‐ HAPIs

COMPANY PROFILE

Project Management,CRAMS & CMO


MEHTA API PLANT

BLOCK “A” with Large Volume Products BLOCK “B” for Medium Scale Production

BLOCK “C” with different Facilities and Capabilities for Small Scale Production

BLOCK “D” is dedicated Production Area for HAPI with isolator Department

C

DA

B


CORE BUSINESS

MANUFACTURING OF APIS , HAPIs AND ADVANCED INTERMEDIATES

CRAMs &

CMO

FDF DOSSIERPMV LIFE SCIENCE

PATENT OUT LICENCING

CMO BUSINESS


EXPORT MARKET

Europe Asia MENA Africa

Austria Slovenia Bangladesh Sri Lanka Egypt Ghana

Belgium Spain Hong Kong Taiwan Iran Kenya

Cyprus UK Indonesia Thailand Iraq South Africa

Finland Latin America S. Korea Vietnam Israel Sudan

Ireland Brazil Japan Jordan Tanzania

Poland Mexico Malaysia CIS Syria Zimbabwe

Romania Guatemala Philippines Belarus UAE

Turkey America Pakistan Russia Australia

Switzerland Canada Singapore


CONTRACT RESEARCH & MANUFACTURING

Working under confidentiality agreement.

Non infringing process & Patentable process

Highly qualified and experienced chemists

Cost efficient processes of API & advance intermediates using green chemistry

High quality product meeting ICH guidelines and customer specification

Polymorph studies

Technology transfer

High potent API


• Planning for US FDA/PMDA shortly.

APPROVALS & CERTIFICATES VALIDITY

Manufacturing License from FDA (Maharashtra state) 19/10/2017

GMP Certification from FDA (Maharashtra State) 03/06/2017

WHO Certification 19/06/2017

Manufacturing Site’s D‐U‐N‐S No 650656957

Registered Office D‐U‐N‐S No 869493571

Block A and Block B approved by EDQM, Swiss Medic (Pics) and TGA Plant audited on 7/8/9th December 2012.

CEP – Erythromycin Base RO‐CEP 2009‐267‐Rev‐01

CEP‐ Bisoprolol Fumarate RO‐CEP‐2013‐342‐Rev 00

Japan AFM Registration Company code : 784892000 and manufacturing site code: 784892001

Under Registration

APPROVALS AND CERTIFICATES


CERTIFICATIONS

PRODUCTS THERAPEUTIC CATEGORY

Available Status On

TEC

H

PAC

K

US

DM

F

EDM

F/

CEP

MEX

ICO

D

MF

BRA

ZIL

DM

F

KD

MF/

TD

MF/

JD

MF

PATE

NT

Alogliptin* Antidiabetic 2016 2016 2016 2016 2016 2016

Apremilast* Anti-Inflammatory 2016 2016 2016 2016 2016 2016 Azithromycin Dihydrate Macrolides -

Agomelatine Form II Antidepressant

India Agomelatine Form

Co Crystal* 2016 2016 2016 2016 2016

Aprepitant Form I And Form II Anti-Emetic Bisoprolol Hemifumarate (CEP NO..2013-342)

Anti Hypertensive

Bazedoxifene Acetate Form A&B Selective Estrogen Receptor Modulator 2016 2016 2016 2016 2016

Beraprost* Pulmonary Hypertension 2016 2016 2016 2016 2016 2016

Brexpiprazole* Antidepressant 2016 2016 2016 2016 2016 2016

Chloramphenicol Base &Palmitate

Anti Bacterial - - - - -

Cinacalcet Hcl Form I Calcimimetic PCT/India

Empagliflozin* Antidiabetic 2016 2016 2016 2016 2016 2016

Dabigrtran Etexilate Mesylate

Dapagliflozin Antidiabetic 2016 2016 2016 2016 2016 2016

Erythromycin Base- CEP NO RO-CEP 2009-267

Macrolides

Erythromycin Ethyl Succinate (CEP NO ..2015-211)

Erythromycin Stearate (CEP NO.. 2015-225)

Edoxaban* Anticoagulant 2016 2016 2016 2016 2016 2016

Fluvoxamine Maleate Antidepressant

Linagliptin Antidiabetic 2016 2016 2016 2016 2016 2016

Macitentan* Antihypertensive 2016 2016 2016 2016 2016 2016

Mirabegron Adrenergic Receptor

2016 2016 2016 2016 2016 2016

Rivaroxaban Anticoagulant 2016 2016 2016 2016 2016 2016 India

Teneligliptin* Antidiabetic 2016 2016 2016 2016 2016 2016 Remarks:* Under development/evaluation. Available.

All transactions are carried out in conformity with patent laws applicable in the user country, responsibility with respect to third parties rightsin a specific country lies exclusively with the user. The above products are offered as per BP/EP/USP/JP and FP and

as per customer’s in‐house specifications. Also available in Microfine.

Email :[email protected] & Web site: www.mehtaapi.com

PRODUCT LIST

NAME OF INTERMEDIATES

CAS NO END PRODUCT

7-Methoxy-1-naphthylacetonitrile

138113-08-3 Agomelatine

2-[(6-Chloro-3,4-dihydro-3-Methyl-2,4-dioxo-1(2h)-pyriMidinyl)Methyl]benzonitrile

865758-96-9* Alogliptin

Tert-butyl (R)-piperidin-3-ylcarbamate/(R)-piperidin-3-amine dihydrochloride

334618-23-4*

N-Methylcarbonyl-2-Chloroacetamidrazone

155742-64-6 Aprepitant

(2R,3S)-2-[(1R)-1-[3,5-is(trifluoromethyl)phenyl]ethoxy]-3-(4-fluorophenyl)morpholine hydrochloride

171482-05-6

3-AcetaMidophthalic anhydride

6296-53-3 Apremilast

Azithromycin Amine

76801-85-9 Azithromycin Dihydrate

3-Methyl-5(phenylmethoxy)-2-[4-(phenylmethoxy)phenyl]-1H-indole

198479-63-9 Bazedoxifene

1-(2-(4-(Chloromethyl)phenoxy)ethyl)azepane HCL

223251-25-0

1-[4-(2-Azepan-1-yl-ethoxy)-benzyl]-5-benzyloxy-2-(4-benzyloxy -phenyl)-3-methyl-1h-indole

198480-21-6

2-{3-[5-(4-Fluoro-phenyl)-thiophen-2-ylmethyl]-4-methyl-phenyl}-3,4,5-tris-trimethylsilanyloxy-6-trimethylsilanyloxymethyl-tetrahydro-pyran-2-ol

1132832-76-8 Canagliflozin

2,3,4,6-Tetrakis-O-trimethylsilyl-D-gluconolactone

32384-65-9 Canagliflozin/Dapagliflozin

3-(3'-Trifluoromethylphenyl)propanol

78573-45-2 Cinacalcet

3-[(3-Amino-4-methylaminobenzoyl)pyridine-2-ylamino]propionic acid with ethyl ester

212322-56-0 Dabigatran

2,3,4,6-Tetra-O-pivaloyl-alpha-D-glucopyranosyl bromide

81058-27-7 Dapagliflozin

1-(1,2,3,6-Tetrahydro-4-pyridyl)-2-Benzimidazolione 2147-83-3 Droperidol

tert-Butyl [(1R,2S,5S)-2-amino-5-[(dimethylamino)carbonyl]cyclohexyl]carbamate oxalate

1210348-34-7 Edoxaban

5-Methoxy -1-[4-(trifluromethyl)phenyl]-1-pentan oxime

61747-22-6 Fluvoxamine Maleate

1,3-Dihydro-3-(3-iodopropyl)-7,8-dimethoxy-2H-3-benzazepin-2-one

148870‐57‐9 Evabradine (Z)-3-(3-chloropropyl)-7,8-diethyl-1H-benzo[d] azepin-2 (3H)-one

85175-59-3

INTERMEDIATE LIST

NAME OF INTERMEDIATES

CAS NO END PRODUCT

(R)-N-benzyl-2-t-butoxycarbonylamino-3-methoxy propanamide

880468-89-3 Lacosamide

(R)-N-benzyl-2-t-butoxycarbonylamino-3-hydroxy propanamide

1253790-58-7

1-{(4-methyl-quianazolin-2yl)methyl}-3-methyl-7-(2-butyn-1-yl)-8-bromo-xanthine

853029-57-9 Linagliptin

Tert-butyl (R)-piperidin-3-ylcarbamate/(R)-piperidin-3-amine dihydrochloride

334618-23-4

Erythromycin Oxime

13127-18-19 Macrolide

(1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol HCL

521284-22-0 Mirabegron

S-1-decyn-O-tert dimethyl silyl-2-yl-5-ol

Prostaglandin

2-[[(5S)-2-Oxo-3-[4-(3-oxo-4-morpholinyl)phenyl]-5-oxazolidinyl]methyl]-1H-isoindole-1,3(2H)-dione

446292-08-6 Rivaroxaban

4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one Hydrochloride

898543-06-1

5-Bromo-2-(2-methyl-2H-tetrazol-5-yl)pyridine

380380-64-3 Tedizolid

1-(3-Methyl-1-phenyl-5-pyrazolyl)piperazine

401566-79-8 Tenaligliptin

2S)-4-oxo-2-(1,3-thiazolidin-3-ylcarbonyl)pyrrolidine-1-carboxylate

401564-36-1

1-Naphthalenesulfonic acid, (diethoxyphosphinyl)methyl ester

145980-33-2 Tenofovir

Remarks:* Under development/evaluation. Available.

All transactions are carried out in conformity with patent laws applicable in the user country, responsibility with respect to third

parties rightsin a specific country lies exclusively with the user. The above products are offered as per BP/EP/USP/JP and FP and as per customer’s in‐house specifications. Also available in Microfine.

Email :[email protected] & Web site: www.mehtaapi.com


MARKET EXISTENCE


THANK YOUMEHTA API looks forward to work together for enriching lives globally…

Contact at HO :

Mehta API P. Ltd. , 203, Centre Point, 2nd Floor, Near Hotel Kohinoor, J.B.Nagar, Andheri-Kurla Road, Andheri (East), Mumbai - 400059 Board No: 91-22-28395643/45 Fax no : 91-22-28395644 Email Id: [email protected] & [email protected]

Web: www.mehtaapi.com

Mehta API Pvt. Ltd - Research, Process Development ...€¦ · property development, Strategic...

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