01 1Shandong Anhong Pharmaceutical Co. , Ltd.
01 1Ropivacaine Hydrochloride Hydrate
01 1China
Ropivacaine hydrochloride hydrate
Registration Number : 305MF10079
Registrant's Address : No. 29 Huayuan Street Linyi County, Dezhou, Shandong, China
Initial Date of Registration : 2023-07-12
Latest Date of Registration : 2023-07-12
A Naropin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naropin, including repackagers and relabelers. The FDA regulates Naropin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naropin 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 Naropin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naropin supplier is an individual or a company that provides Naropin active pharmaceutical ingredient (API) or Naropin finished formulations upon request. The Naropin suppliers may include Naropin API manufacturers, exporters, distributors and traders.
click here to find a list of Naropin 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 Naropin Drug Master File in Japan (Naropin JDMF) empowers Naropin 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 Naropin JDMF during the approval evaluation for pharmaceutical products. At the time of Naropin 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 Naropin suppliers with JDMF on PharmaCompass.
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