01 1Amsa
02 1Abbott Laboratories
03 1Cambrex Corporation
04 1China Chemical & Pharmaceutical
05 1J.B.Chemicals & Pharmaceuticals
06 1Kreative Organics
07 1Lupin Ltd
08 1Olon S.p.A
09 1Pfizer Inc
10 1Sri Krishna Pharmaceuticals
11 1Sumitomo Chemical
12 1Taizhou Highsun Pharmaceutical Co.,Ltd.
13 1USV Private Limited
14 1Unichem Laboratories Limited
15 1Urquima S.A. Grupo Uriach
16 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-21
Pay. Date : 2013-09-23
DMF Number : 13101
Submission : 1998-07-30
Status :
Type : II
76
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A Glucotrol XL, Glucotrol, Glipizide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glucotrol XL, Glucotrol, Glipizide, including repackagers and relabelers. The FDA regulates Glucotrol XL, Glucotrol, Glipizide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glucotrol XL, Glucotrol, Glipizide 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 Glucotrol XL, Glucotrol, Glipizide supplier is an individual or a company that provides Glucotrol XL, Glucotrol, Glipizide active pharmaceutical ingredient (API) or Glucotrol XL, Glucotrol, Glipizide finished formulations upon request. The Glucotrol XL, Glucotrol, Glipizide suppliers may include Glucotrol XL, Glucotrol, Glipizide API manufacturers, exporters, distributors and traders.
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A Glucotrol XL, Glucotrol, Glipizide DMF (Drug Master File) is a document detailing the whole manufacturing process of Glucotrol XL, Glucotrol, Glipizide active pharmaceutical ingredient (API) in detail. Different forms of Glucotrol XL, Glucotrol, Glipizide DMFs exist exist since differing nations have different regulations, such as Glucotrol XL, Glucotrol, Glipizide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glucotrol XL, Glucotrol, Glipizide DMF submitted to regulatory agencies in the US is known as a USDMF. Glucotrol XL, Glucotrol, Glipizide USDMF includes data on Glucotrol XL, Glucotrol, Glipizide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glucotrol XL, Glucotrol, Glipizide USDMF is kept confidential to protect the manufacturer’s intellectual property.
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