Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
01 1Centrient Pharmaceuticals
02 1ACS DOBFAR SPA
03 1ADL BioPharma
04 2Aurobindo Pharma Limited
05 1Bayer AG
06 3Bristol Myers Squibb
07 1CSPC Pharmaceutical Group
08 1CordenPharma
09 1Fermenta Biotech Limited
10 1Fresenius Kabi AB Brunna
11 3GSK
12 2Inner Mongolia Changsheng Pharmaceutical
13 1Kopran
14 1North China Pharmaceutical Co., Ltd.
15 1Pfizer Inc
16 1Pierrel
17 1Plantex Ltd.
18 1Royal DSM
19 1Sandoz B2B
20 1Sinopharm Weiqida Pharmaceutical Co Ltd
21 1Sun Pharmaceutical Industries Limited
22 1Teva Pharmaceutical Industries
23 1Zhuhai United Laboratories Co ., Ltd.
24 7Blank
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26505
Submission : 2012-10-30
Status :
Type : II
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A AMPICILLIN TRIHYDRATE STERILE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMPICILLIN TRIHYDRATE STERILE, including repackagers and relabelers. The FDA regulates AMPICILLIN TRIHYDRATE STERILE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMPICILLIN TRIHYDRATE STERILE 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 AMPICILLIN TRIHYDRATE STERILE supplier is an individual or a company that provides AMPICILLIN TRIHYDRATE STERILE active pharmaceutical ingredient (API) or AMPICILLIN TRIHYDRATE STERILE finished formulations upon request. The AMPICILLIN TRIHYDRATE STERILE suppliers may include AMPICILLIN TRIHYDRATE STERILE API manufacturers, exporters, distributors and traders.
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A AMPICILLIN TRIHYDRATE STERILE DMF (Drug Master File) is a document detailing the whole manufacturing process of AMPICILLIN TRIHYDRATE STERILE active pharmaceutical ingredient (API) in detail. Different forms of AMPICILLIN TRIHYDRATE STERILE DMFs exist exist since differing nations have different regulations, such as AMPICILLIN TRIHYDRATE STERILE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AMPICILLIN TRIHYDRATE STERILE DMF submitted to regulatory agencies in the US is known as a USDMF. AMPICILLIN TRIHYDRATE STERILE USDMF includes data on AMPICILLIN TRIHYDRATE STERILE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMPICILLIN TRIHYDRATE STERILE USDMF is kept confidential to protect the manufacturer’s intellectual property.
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