Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1Moehs Iberica
02 1TAPI Technology & API Services
03 2Bayer AG
04 1Cadila Pharmaceuticals
05 2Catalent Pharma Solutions
06 1China Chemical & Pharmaceutical
07 1Cipla
08 1Dipharma
09 1F.I.S. Fabbrica Italiana Sintetici
10 2J.B.Chemicals & Pharmaceuticals
11 1Kremers Urban Pharmaceuticals
12 1Krka
13 1Lek Pharmaceuticals
14 1Lusochimica
15 1NORDIC SYNTHESIS AB
16 1PROMETIC BIOSCIENCES LTD
17 6RP SCHERER GMBH & CO. KG
18 1Sharon Bio-Medicine Limited
19 1Shilpa Medicare
20 1Siegfried AG
21 1Unichem Laboratories Limited
22 9Blank
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-02
Pay. Date : 2013-03-25
DMF Number : 7504
Submission : 1988-06-03
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 : 2012-11-30
Pay. Date : 2012-11-09
DMF Number : 6197
Submission : 1985-12-03
Status :
Type : II
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A N0528 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of N0528, including repackagers and relabelers. The FDA regulates N0528 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. N0528 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A N0528 supplier is an individual or a company that provides N0528 active pharmaceutical ingredient (API) or N0528 finished formulations upon request. The N0528 suppliers may include N0528 API manufacturers, exporters, distributors and traders.
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A N0528 DMF (Drug Master File) is a document detailing the whole manufacturing process of N0528 active pharmaceutical ingredient (API) in detail. Different forms of N0528 DMFs exist exist since differing nations have different regulations, such as N0528 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A N0528 DMF submitted to regulatory agencies in the US is known as a USDMF. N0528 USDMF includes data on N0528's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The N0528 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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