AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1AMI LIFE SCIENCES PVT. LTD.
02 2ALCHYMARS ICM SM PRIVATE LIMITED.
03 2Bidachem S. p. A
04 1Cambrex Profarmaco Milano S. r. l.
05 1Chemiclear Inc.
06 1DONG WHA PHARM. IND. C.O. , LTD.
07 2Dong Wha Pharm. Co. , Ltd.
08 1ERREGIERRE S. p. A.
09 1Shilpa Pharma Lifesciences Limited
10 1Shizuoka Caffeine Industry Co., Ltd.
11 1Yamamoto Chemical Industry Co., Ltd.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registration Number : 305MF10118
Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...
Initial Date of Registration : 2023-11-01
Latest Date of Registration : 2023-11-01
A Ambroxol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambroxol Hydrochloride, including repackagers and relabelers. The FDA regulates Ambroxol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambroxol 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 Ambroxol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambroxol Hydrochloride supplier is an individual or a company that provides Ambroxol Hydrochloride active pharmaceutical ingredient (API) or Ambroxol Hydrochloride finished formulations upon request. The Ambroxol Hydrochloride suppliers may include Ambroxol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ambroxol 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 Ambroxol Hydrochloride Drug Master File in Japan (Ambroxol Hydrochloride JDMF) empowers Ambroxol 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 Ambroxol Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ambroxol 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 Ambroxol Hydrochloride suppliers with JDMF on PharmaCompass.
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