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 Mycostatin, Nilstat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mycostatin, Nilstat, including repackagers and relabelers. The FDA regulates Mycostatin, Nilstat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mycostatin, Nilstat 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 Mycostatin, Nilstat supplier is an individual or a company that provides Mycostatin, Nilstat active pharmaceutical ingredient (API) or Mycostatin, Nilstat finished formulations upon request. The Mycostatin, Nilstat suppliers may include Mycostatin, Nilstat API manufacturers, exporters, distributors and traders.
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A Mycostatin, Nilstat DMF (Drug Master File) is a document detailing the whole manufacturing process of Mycostatin, Nilstat active pharmaceutical ingredient (API) in detail. Different forms of Mycostatin, Nilstat DMFs exist exist since differing nations have different regulations, such as Mycostatin, Nilstat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mycostatin, Nilstat DMF submitted to regulatory agencies in the US is known as a USDMF. Mycostatin, Nilstat USDMF includes data on Mycostatin, Nilstat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mycostatin, Nilstat USDMF is kept confidential to protect the manufacturer’s intellectual property.
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