Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
01 1Olpha
02 1Cohance Lifesciences
03 1Dr. Reddy's Laboratories
04 1TAPI Technology & API Services
05 1Alembic Pharmaceuticals Limited
06 1Amsa Spa
07 1Apotex Pharmachem
08 1Emcure Pharmaceuticals
09 1Esteve Quimica
10 2Hainan Poly Pharm
11 1Hetero Drugs
12 1Hikal
13 1Industriale Chimica
14 1Lupin Ltd
15 1MSN Laboratories
16 2Macleods Pharmaceuticals Limited
17 1Megafine Pharma (P) Limited
18 1Olon S.p.A
19 1Orchid Pharma
20 1Procos
21 1RANBAXY LABORATORIES LIMITED
22 1Sharon Bio-Medicine Limited
23 1Sun Pharmaceutical Industries Limited
24 1Tai Heng Industry Co., Ltd
25 1Teva Pharmaceutical Industries
26 1UQUIFA
27 1Unichem Laboratories Limited
28 1Viatris
29 1Zhejiang Supor Pharmaceuticals Co., LTD
30 2Zydus Lifesciences
31 1Blank
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-11-27
DMF Number : 20543
Submission : 2007-05-09
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-22
Pay. Date : 2019-02-11
DMF Number : 29180
Submission : 2015-03-16
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2015-11-13
Pay. Date : 2015-11-05
DMF Number : 20841
Submission : 2007-09-07
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-09
DMF Number : 20868
Submission : 2007-09-20
Status :
Type : II
A Memantine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Memantine, including repackagers and relabelers. The FDA regulates Memantine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Memantine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Memantine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Memantine supplier is an individual or a company that provides Memantine active pharmaceutical ingredient (API) or Memantine finished formulations upon request. The Memantine suppliers may include Memantine API manufacturers, exporters, distributors and traders.
click here to find a list of Memantine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Memantine DMF (Drug Master File) is a document detailing the whole manufacturing process of Memantine active pharmaceutical ingredient (API) in detail. Different forms of Memantine DMFs exist exist since differing nations have different regulations, such as Memantine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Memantine DMF submitted to regulatory agencies in the US is known as a USDMF. Memantine USDMF includes data on Memantine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Memantine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Memantine suppliers with USDMF on PharmaCompass.
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