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01 1Macfarlan Smith Limited
02 1Pioneer Agro Industries (Pharmaceutical Division) Prop. Sanvin Laboratories Pvt. Ltd.
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01 1Buprenorphine Hydrochloride
02 1Buprenorphine hydrochloride
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01 1India
02 1U.S.A
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2013-11-11
Registration Number : 231MF10001
Registrant's Address : 206, Eric House, 16th Road, Chembur, Mumbai-400071. INDIA
Initial Date of Registration : 2019-01-10
Latest Date of Registration : 2019-01-10
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BUPRENORPHINE HYDROCHLORIDE AND NALOXONE 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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE supplier is an individual or a company that provides BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE active pharmaceutical ingredient (API) or BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE finished formulations upon request. The BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE suppliers may include BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE 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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE Drug Master File in Japan (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE JDMF) empowers BUPRENORPHINE HYDROCHLORIDE AND NALOXONE 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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE 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 BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE suppliers with JDMF on PharmaCompass.
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