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01 1SANOFI WINTHROP INDUSTRIE
02 1Dandong Yichuang Pharmaceutical Co. ,Ltd
01 2Promethazine hydrochloride
01 1China
02 1France
Registration Number : 220MF10196
Registrant's Address : 82 Avenue Raspail 94250 Gentilly France
Initial Date of Registration : 2008-08-28
Latest Date of Registration : 2011-11-17
Registration Number : 218MF10771
Registrant's Address : No. 64 Xingqi Road, Zhexing District, Dandong, Liaoning, China
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2009-06-30
A Promethazine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Promethazine Hydrochloride, including repackagers and relabelers. The FDA regulates Promethazine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Promethazine Hydrochloride 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 Promethazine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Promethazine Hydrochloride supplier is an individual or a company that provides Promethazine Hydrochloride active pharmaceutical ingredient (API) or Promethazine Hydrochloride finished formulations upon request. The Promethazine Hydrochloride suppliers may include Promethazine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Promethazine Hydrochloride 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 Promethazine Hydrochloride Drug Master File in Japan (Promethazine Hydrochloride JDMF) empowers Promethazine Hydrochloride 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 Promethazine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Promethazine Hydrochloride 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 Promethazine Hydrochloride suppliers with JDMF on PharmaCompass.
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