AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
02 1Medichem S.A
03 3TAPI Technology & API Services
04 3Alembic Pharmaceuticals Limited
05 1Amoli Organics
06 1Apotex Pharmachem
07 2Atul Bioscience Ltd
08 1Aurore Life Sciences
09 1Cadila Pharmaceuticals
10 1Hetero Drugs
11 1Hikal
12 1Hubei Haosun Pharmaceutical Co., Ltd.
13 1Lupin Ltd
14 2MSN Laboratories
15 1Macleods Pharmaceuticals Limited
16 1Siegfried AG
17 1Viatris
18 1Wockhardt
19 1Zhejiang Apeloa Jiayuan Pharmaceutical
20 2Zydus Lifesciences
21 1Blank
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38066
Submission : 2023-03-03
Status :
Type : II
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-02-01
Pay. Date : 2019-01-28
DMF Number : 25612
Submission : 2011-12-22
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 : 2013-06-06
Pay. Date : 2012-11-07
DMF Number : 25749
Submission : 2012-01-30
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 : 2024-06-24
Pay. Date : 2024-06-17
DMF Number : 26357
Submission : 2012-08-26
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 25747
Submission : 2012-01-30
Status :
Type : II
A Pristiq manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pristiq, including repackagers and relabelers. The FDA regulates Pristiq manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pristiq 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 Pristiq manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pristiq supplier is an individual or a company that provides Pristiq active pharmaceutical ingredient (API) or Pristiq finished formulations upon request. The Pristiq suppliers may include Pristiq API manufacturers, exporters, distributors and traders.
click here to find a list of Pristiq suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pristiq DMF (Drug Master File) is a document detailing the whole manufacturing process of Pristiq active pharmaceutical ingredient (API) in detail. Different forms of Pristiq DMFs exist exist since differing nations have different regulations, such as Pristiq USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pristiq DMF submitted to regulatory agencies in the US is known as a USDMF. Pristiq USDMF includes data on Pristiq's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pristiq USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pristiq suppliers with USDMF on PharmaCompass.
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