01 1Zhejiang Huahai Pharmaceutical
01 1NEVIRAPINE HEMIHYDRATE USP
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-11-17
Pay. Date : 2016-07-26
DMF Number : 29606
Submission : 2016-07-14
Status : Active
Type : II
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A Nevirapine hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nevirapine hemihydrate, including repackagers and relabelers. The FDA regulates Nevirapine hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nevirapine hemihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Nevirapine hemihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Nevirapine hemihydrate supplier is an individual or a company that provides Nevirapine hemihydrate active pharmaceutical ingredient (API) or Nevirapine hemihydrate finished formulations upon request. The Nevirapine hemihydrate suppliers may include Nevirapine hemihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Nevirapine hemihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Nevirapine hemihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Nevirapine hemihydrate active pharmaceutical ingredient (API) in detail. Different forms of Nevirapine hemihydrate DMFs exist exist since differing nations have different regulations, such as Nevirapine hemihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nevirapine hemihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Nevirapine hemihydrate USDMF includes data on Nevirapine hemihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nevirapine hemihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nevirapine hemihydrate suppliers with USDMF on PharmaCompass.
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