Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1Antibiotice SA
03 4Bristol Myers Squibb
04 1Olon S.p.A
05 1Pfizer Inc
06 1VUAB Pharma
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 : 2013-08-07
Pay. Date : 2013-07-29
DMF Number : 13523
Submission : 1998-09-01
Status :
Type : II
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A MYCOLOG-II manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MYCOLOG-II, including repackagers and relabelers. The FDA regulates MYCOLOG-II manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MYCOLOG-II 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 MYCOLOG-II supplier is an individual or a company that provides MYCOLOG-II active pharmaceutical ingredient (API) or MYCOLOG-II finished formulations upon request. The MYCOLOG-II suppliers may include MYCOLOG-II API manufacturers, exporters, distributors and traders.
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A MYCOLOG-II DMF (Drug Master File) is a document detailing the whole manufacturing process of MYCOLOG-II active pharmaceutical ingredient (API) in detail. Different forms of MYCOLOG-II DMFs exist exist since differing nations have different regulations, such as MYCOLOG-II USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MYCOLOG-II DMF submitted to regulatory agencies in the US is known as a USDMF. MYCOLOG-II USDMF includes data on MYCOLOG-II's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MYCOLOG-II USDMF is kept confidential to protect the manufacturer’s intellectual property.
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