Apex Healthcare Limited: ISO 9001:2008, WHO-GMP, US FDA-audited manufacturer & exporter of APIs, bulk drugs, and formulations.
01 1Apex Healthcare Limited
02 1Arch Pharmalabs
03 1Dipharma
04 1Esteve Quimica
05 1F.I.S. Fabbrica Italiana Sintetici
06 1Krka
07 1Ramdev Chemicals Pvt Ltd
08 1Sifavitor srl
09 1Unichem Laboratories Limited
10 1Wockhardt
11 3Blank
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 : 36841
Submission : 2022-02-25
Status :
Type : II
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A C15H13N3O4S manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C15H13N3O4S, including repackagers and relabelers. The FDA regulates C15H13N3O4S manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C15H13N3O4S 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 C15H13N3O4S supplier is an individual or a company that provides C15H13N3O4S active pharmaceutical ingredient (API) or C15H13N3O4S finished formulations upon request. The C15H13N3O4S suppliers may include C15H13N3O4S API manufacturers, exporters, distributors and traders.
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A C15H13N3O4S DMF (Drug Master File) is a document detailing the whole manufacturing process of C15H13N3O4S active pharmaceutical ingredient (API) in detail. Different forms of C15H13N3O4S DMFs exist exist since differing nations have different regulations, such as C15H13N3O4S USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C15H13N3O4S DMF submitted to regulatory agencies in the US is known as a USDMF. C15H13N3O4S USDMF includes data on C15H13N3O4S's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C15H13N3O4S USDMF is kept confidential to protect the manufacturer’s intellectual property.
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