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