01 1Unimark Remedies
02 1Acebright India Pharma Private Limited
03 1Aurisco Pharmaceutical
04 1Aurobindo Pharma Limited
05 1Chromo Laboratories
06 2Cipla
07 2Emcure Pharmaceuticals
08 1Emnar Pharma
09 2Hetero Drugs
10 3Laurus Labs
11 1Lupin Ltd
12 1Macleods Pharmaceuticals Limited
13 1Qilu Antibiotics Pharmaceutical Co., Ltd.
14 1SeQuent Scientific
15 1Shanghai Desano Bio-Pharmaceutical
16 1Shijiazhuang Lonzeal Pharmac.Co. ltd
17 1Solara Active Pharma Sciences
18 1Styrax
19 1Sun Pharmaceutical Industries Limited
20 1Tyche Industries Ltd
21 2Viatris
22 1Viyash Life Sciences
23 1Zhejiang Candorly Pharmaceutical
24 1Zhejiang Huahai Pharmaceutical
25 1Zhejiang Supor Pharmaceuticals Co., LTD
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26319
Submission : 2012-08-29
Status :
Type : II
33
PharmaCompass offers a list of Tenofovir Disoproxil Fumarate 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 Tenofovir Disoproxil Fumarate manufacturer or Tenofovir Disoproxil Fumarate supplier for your needs.
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A Tenofovir Disoproxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenofovir Disoproxil, including repackagers and relabelers. The FDA regulates Tenofovir Disoproxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenofovir Disoproxil 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 Tenofovir Disoproxil supplier is an individual or a company that provides Tenofovir Disoproxil active pharmaceutical ingredient (API) or Tenofovir Disoproxil finished formulations upon request. The Tenofovir Disoproxil suppliers may include Tenofovir Disoproxil API manufacturers, exporters, distributors and traders.
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A Tenofovir Disoproxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Tenofovir Disoproxil active pharmaceutical ingredient (API) in detail. Different forms of Tenofovir Disoproxil DMFs exist exist since differing nations have different regulations, such as Tenofovir Disoproxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tenofovir Disoproxil DMF submitted to regulatory agencies in the US is known as a USDMF. Tenofovir Disoproxil USDMF includes data on Tenofovir Disoproxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tenofovir Disoproxil USDMF is kept confidential to protect the manufacturer’s intellectual property.
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