01 1Zhejiang Huahai Pharmaceutical Co. , Ltd.
01 1Nevirapine
01 1China
Registration Number : 227MF10149
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2015-05-26
Latest Date of Registration : 2021-03-17
A Nevirapine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nevirapine, including repackagers and relabelers. The FDA regulates Nevirapine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nevirapine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nevirapine supplier is an individual or a company that provides Nevirapine active pharmaceutical ingredient (API) or Nevirapine finished formulations upon request. The Nevirapine suppliers may include Nevirapine API manufacturers, exporters, distributors and traders.
click here to find a list of Nevirapine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Nevirapine Drug Master File in Japan (Nevirapine JDMF) empowers Nevirapine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Nevirapine JDMF during the approval evaluation for pharmaceutical products. At the time of Nevirapine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Nevirapine suppliers with JDMF on PharmaCompass.
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