World Class Pharma Ingredients - Neuland Labs · World Class Pharma Ingredients API Product List...
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World Class Pharma Ingredients API Product List For further details visit: www.neulandlabs.com Neuland’s core business and operational expertise has, for over 32 years, been the manufacturing and marketing of active pharmaceutical ingredients (APIs). During this time Neuland has become a preferred and reliable source for leading pharmaceutical companies worldwide. This is primarily due to: consistency in product quality; knowledge and ability to deal with niche chemistry; and on-time delivery performance. With two world-class manufacturing facilities (both USFDA and EU GMP compliant) and a state-of-art R&D centre, Neuland currently produces more than 50 APIs in diverse therapeutic areas with over 400 DMFs worldwide. The Company’s strength in process development, regulatory knowledge, controlled supply chain and online project management makes Neuland an ideal API partner. Additionally, with proven experience of API manufacturing at varied scales, Neuland also offers Custom Manufacturing Solutions (CMS) as well as custom synthesis services for small molecules and peptides. March 2017
Transcript of World Class Pharma Ingredients - Neuland Labs · World Class Pharma Ingredients API Product List...
World Class Pharma Ingredients
APIProduct List
For further details visit: www.neulandlabs.com
Neuland’s core business and operational expertise has, for over 32 years, been the manufacturing and marketing of active pharmaceutical ingredients (APIs). During this time Neuland has become a preferred and reliable source for leading pharmaceutical companies worldwide. This is primarily due to: consistency in product quality; knowledge and ability to deal with niche chemistry; and on-time delivery performance.
With two world-class manufacturing facilities (both USFDA and EU GMP compliant) and a state-of-art R&D centre, Neuland currently produces more than 50 APIs in diverse therapeutic areas with over 400 DMFs worldwide.
The Company’s strength in process development, regulatory knowledge, controlled supply chain and online project management makes Neuland an ideal API partner. Additionally, with proven experience of API manufacturing at varied scales, Neuland also o�ers Custom Manufacturing Solutions (CMS) as well as custom synthesis services for small molecules and peptides.
March 2017
API Product List
For further details visit: www.neulandlabs.com
Commercial & Commercial-Scale ProductsProduct Therapeutic Segment USDMF CEP/E-DMF
Albuterol Sulfate/Salbutamol Sulphate Bronchodilator ✔ CEP
Alcaftadine Allergic Conjunctivitis (Opthalmic) ✔ N/A
Apixaban Anticoagulant Ⓟ ⓅApremilast Psoriatic Arthritis Ⓥ ⓋAripiprazole Anhydrate Antipsychotic Ⓟ ⓅAripiprazole Monohydrate (Sterile) Antipsychotic Ⓥ ⓋBosentan Monohydrate Antihypertensive ✔ E-DMF
Cipro�oxacin Base Antibacterial ✔ CEP
Cipro�oxacin Hydrochloride Antibacterial ✔ CEP
Dabigatran Etexilate Mesylate † Anticoagulant ✔ ⓅDeferasirox Iron Chelator ✔ E-DMF
Donepezil Base Antialzheimer's N\A E-DMF
Donepezil Hydrochloride Antialzheimer's ✔ E-DMF
Enalapril Maleate Antihypertensive ✔ CEP
Entacapone Antiparkinsonian ✔ CEP
Escitalopram Oxalate Antidepressant ✔ E-DMF
Ezetimibe Antihyperlipidemic ✔ E-DMF
Indacaterol Maleate Bronchodilator Ⓟ ⓋIpratropium Bromide Anticholinergic (COPD) ✔ CEP
Itraconazole Antifungal ✔ CEP
Ivabradine Hydrochloride Antianginal Ⓥ ⓋLabetalol Hydrochloride Antihypertensive ✔ ⓅLacosamide † Anticonvulsant Ⓥ ⓋLevetiracetam Anticonvulsant ✔ CEP
Levo�oxacin Hemihydrate Antibacterial ✔ E-DMF
Linezolid Antibacterial ✔ E-DMF
Lurasidone Hydrochloride Antipsychotic ✔ ⓅMirtazapine Antidepressant ✔ CEP
Moxi�oxacin Hydrochloride Antibacterial ✔ CEP*
Moxonidine Antihypertensive N/A CEP
O�oxacin Antibacterial ✔ E-DMF
Olanzapine Antipsychotic ✔ CEP
Commercial & Commercial-Scale ProductsProduct Therapeutic Segment USDMF CEP/E-DMF
Olanzapine Pamoate Antipsychotic Ⓟ ⓅPaliperidone Palmitate (Sterile) † Antipsychotic Ⓟ ⓅPosaconazole Antifungal Ⓟ ⓅPropofol Anesthetic Ⓟ CEP
Ramipril Antihypertensive ✔ CEP
Rivaroxaban Anticoagulant ✔ ⓅRopinirole Base Antiparkinsonian ✔ E-DMF
Ropinirole Hydrochloride Antiparkinsonian ✔ E-DMF
Rotigotine † Antiparkinsonian Ⓥ ⓋSalmeterol Xinafoate Bronchodilator ✔ CEP
Sotalol Hydrochloride Antiarrhythmic ✔ CEP
Sugammadex † Selective Relaxant Binding Agent (SRBA) Ⓥ ⓋTicagrelor Platelet Aggregation Inhibitors Ⓟ ⓅVoriconazole Antifungal ✔ CEP
R&D Pipeline Products Product Therapeutic Segment
Alogliptin Antidiabetic
Brexpiprazole Antipsychotic
Brivaracetam Anticonvulsant
Canagli�ozin Antidiabetic
Dapagli�ozin Antidiabetic
Empagli�ozin Antidiabetic
Linagliptin Antidiabetic
Pimavanserin Antiparkinsonian
Sacubitril Cardiovascular
Saxagliptin† Antidiabetic
Selexipag Antihypertensive
Sitagliptin Antidiabetic
Vilanterol Bronchodilator
Disclaimer: The above product list includes some products which are still under protection in India and other countries. Products covered under valid patents in India and other countries will be available for supply only after expiry of the respective patents in india and the respective country.Ⓟ Under Preparation Ⓥ Under Validation N/A Not Applicable * Application �led and under review † Patents granted in US / Europe
API Product List
India Corporate O�ce | Tel: +91 40 3021 1600India Mumbai O�ce | Tel: +91 22 4004 6035Japan O�ce | Tel: +81 3 3526 5171USA O�ce | Tel: +1 888 617 9587
Facilities Certi�cation
Authority Unit 1 (Year) Unit 2 (Year)
USFDA (USA) 1997, 2004, 1999, 2002, 2008, 2010, 2005, 2012, 2014 2015
EDQM (Europe) 2005 –
EMA (Europe) 2013 _
PMDA (Japan) 2008 2008
TGA (Australia) – 2011
BfArM (Germany) – 2007
AFSSAPS (France) – 2012
ANVISA (Brazil) 2012, 2014 2011, 2013, 2015, 2016
COFEPRIS (Mexico) 2014 2014
KFDA (South Korea) 2010, 2014 2012
WHO GMP 2015 2015
ISO 14001:2004 2013 2013
OHSAS 18001:2007 2013 2013
ISO 9001:2008 2014 2014
ISO 27001:2013 2015 2015
India Corporate O�ceNeuland Laboratories Limited, Sanali Info Park, ‘A’ Block, Ground Floor,8-2-120/113, Road No. 2, Banjara Hills, Hyderabad, 500034, Telangana, IndiaTel: +91 40 3021 1600 | Fax: +91 40 3021 1602 | Email: [email protected]
Our R&D centre has been successfully inspected by the USFDA as a Test Facility in 2016
For Business Development enquiries please contact:India: [email protected]: [email protected] America: [email protected]: [email protected] of the World: [email protected]
Our FacilitiesNeuland has two world-class API manufacturing facilities close to the city of Hyderabad, capable of handling complex and hazardous reactions. The manufacturing facilities comply with stringent guidelines and requirements of Good Manufacturing Practices (GMP) and are successfully inspected / approved by international health and regulatory agencies.
Key features include:
● 2 manufacturing plants with 7 production blocks in Unit 1 and 6 production blocks in Unit 2, covering 2,800 to 4,500 m2 of production area, and a mini-plant for scaling up of new products
● Total reactor volume of around 490 KL (180 KL in Unit 1 and 310 KL in Unit 2)
● Capable of handling broad spectrum of reactions and wide range of process parameters
● Over 400 DMFs worldwide, with presence in over 85 countries
● Accomplished with 19 approved CEPs from EDQM to support regulatory MAA (Marketing Authorisation Application) in Europe
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www.neulandlabs.com
