Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 2ACS DOBFAR SPA
03 1Eli Lilly
04 1Lark laboratories
05 1Zhejiang Anglikang Pharmaceutical
06 1elm-plastic GmbH
07 1Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-11
Pay. Date : 2013-01-11
DMF Number : 13210
Submission : 1998-04-30
Status :
Type : II
21
PharmaCompass offers a list of Cephalexin Monohydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cephalexin Monohydrate manufacturer or Cephalexin Monohydrate supplier for your needs.
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A Prindex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prindex, including repackagers and relabelers. The FDA regulates Prindex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prindex 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 Prindex supplier is an individual or a company that provides Prindex active pharmaceutical ingredient (API) or Prindex finished formulations upon request. The Prindex suppliers may include Prindex API manufacturers, exporters, distributors and traders.
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A Prindex DMF (Drug Master File) is a document detailing the whole manufacturing process of Prindex active pharmaceutical ingredient (API) in detail. Different forms of Prindex DMFs exist exist since differing nations have different regulations, such as Prindex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prindex DMF submitted to regulatory agencies in the US is known as a USDMF. Prindex USDMF includes data on Prindex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prindex USDMF is kept confidential to protect the manufacturer’s intellectual property.
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