01 1RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA S. P. A.
01 1Papaverine Hydrochloride
01 1Italy
Registration Number : 231MF10018
Registrant's Address : VIA M. Civitali, 1-20148 MILANO, ITALY
Initial Date of Registration : 2019-01-29
Latest Date of Registration : 2019-01-29
A Papaverine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Papaverine Hydrochloride, including repackagers and relabelers. The FDA regulates Papaverine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Papaverine 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 Papaverine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Papaverine Hydrochloride supplier is an individual or a company that provides Papaverine Hydrochloride active pharmaceutical ingredient (API) or Papaverine Hydrochloride finished formulations upon request. The Papaverine Hydrochloride suppliers may include Papaverine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Papaverine 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 Papaverine Hydrochloride Drug Master File in Japan (Papaverine Hydrochloride JDMF) empowers Papaverine 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 Papaverine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Papaverine 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 Papaverine Hydrochloride suppliers with JDMF on PharmaCompass.
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