Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
01 1Bachem AG
02 1Sanofi
03 1Aspen API
04 1TAPI Technology & API Services
05 1ALP Pharm
06 1AmbioPharm
07 1Anygen
08 1Auro Peptides Limited
09 1BCN Peptides
10 1Chemi SpA
11 1Chinese Peptide Company
12 2Mallinckrodt Pharmaceuticals
13 1Peninsula Laboratories
14 1Piramal Pharma Solutions
15 2PolyPeptide Group
16 1ReaLi Tide Biological Technology
17 1Sun Pharmaceutical Industries Limited
18 6Takeda Pharmaceutical
19 1Viatris
20 1Zhejiang Peptites Biotech Co.,Ltd
21 2Blank
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : Complete
Rev. Date : 2016-09-02
Pay. Date : 2016-04-29
DMF Number : 13822
Submission : 1998-11-06
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14440
Submission : 1999-10-08
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-29
Pay. Date : 2020-11-09
DMF Number : 28808
Submission : 2014-11-06
Status :
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15189
Submission : 2000-12-11
Status :
Type : II
A Leuprolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Leuprolide, including repackagers and relabelers. The FDA regulates Leuprolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Leuprolide 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 Leuprolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Leuprolide supplier is an individual or a company that provides Leuprolide active pharmaceutical ingredient (API) or Leuprolide finished formulations upon request. The Leuprolide suppliers may include Leuprolide API manufacturers, exporters, distributors and traders.
click here to find a list of Leuprolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Leuprolide DMF (Drug Master File) is a document detailing the whole manufacturing process of Leuprolide active pharmaceutical ingredient (API) in detail. Different forms of Leuprolide DMFs exist exist since differing nations have different regulations, such as Leuprolide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Leuprolide DMF submitted to regulatory agencies in the US is known as a USDMF. Leuprolide USDMF includes data on Leuprolide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Leuprolide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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