Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
01 1Apex Healthcare Limited
02 1Unimark Remedies
03 1Alkermes Plc
04 1Amsa Spa
05 1Arch Pharmalabs
06 1Assertio Therapeutics
07 1Aurobindo Pharma Limited
08 1Bidachem
09 1Boehringer Ingelheim GmbH
10 1Cadila Pharmaceuticals
11 1Cipla
12 1Derivados Quimicos SAU
13 1Esteve Quimica
14 1Iroko Pharmaceuticals
15 1Micro Labs Limited
16 1Quimica Sintetica
17 1Ramdev Chemicals Pvt Ltd
18 1SICHUAN SANCHINE SUNNYHOPE PHARMACEUTICAL CO LTD
19 1Shandong Xinhua Pharmaceutical
20 1Swati Spentose
21 1Unichem Laboratories Limited
22 1Zydus Lifesciences
Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39911
Submission : 2024-05-06
Status :
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18286
Submission : 2005-04-19
Status :
Type : II
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A Coxflam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Coxflam, including repackagers and relabelers. The FDA regulates Coxflam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Coxflam 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 Coxflam supplier is an individual or a company that provides Coxflam active pharmaceutical ingredient (API) or Coxflam finished formulations upon request. The Coxflam suppliers may include Coxflam API manufacturers, exporters, distributors and traders.
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A Coxflam DMF (Drug Master File) is a document detailing the whole manufacturing process of Coxflam active pharmaceutical ingredient (API) in detail. Different forms of Coxflam DMFs exist exist since differing nations have different regulations, such as Coxflam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Coxflam DMF submitted to regulatory agencies in the US is known as a USDMF. Coxflam USDMF includes data on Coxflam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Coxflam USDMF is kept confidential to protect the manufacturer’s intellectual property.
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