Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1TAPI Technology & API Services
03 2ACS DOBFAR SPA
04 1Ajanta Pharma Limited
05 1Aurobindo Pharma Limited
06 1Bristol Myers Squibb
07 1CordenPharma
08 1Hikma Pharmaceuticals
09 1Lupin Ltd
10 1Orchid Pharma
11 2Sun Pharmaceutical Industries Limited
12 3Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-01-11
DMF Number : 13749
Submission : 1998-09-01
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 17509
Submission : 2004-07-01
Status :
Type : II
24
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A Ultracef manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultracef, including repackagers and relabelers. The FDA regulates Ultracef manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultracef 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 Ultracef supplier is an individual or a company that provides Ultracef active pharmaceutical ingredient (API) or Ultracef finished formulations upon request. The Ultracef suppliers may include Ultracef API manufacturers, exporters, distributors and traders.
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A Ultracef DMF (Drug Master File) is a document detailing the whole manufacturing process of Ultracef active pharmaceutical ingredient (API) in detail. Different forms of Ultracef DMFs exist exist since differing nations have different regulations, such as Ultracef USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ultracef DMF submitted to regulatory agencies in the US is known as a USDMF. Ultracef USDMF includes data on Ultracef's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ultracef USDMF is kept confidential to protect the manufacturer’s intellectual property.
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