Veranova: A CDMO that manages complexity with confidence.
01 1Macfarlan Smith Limited
02 1Pioneer Agro Industries (Pharmaceutical Division) Prop. Sanvin Laboratories Pvt. Ltd.
01 1Buprenorphine Hydrochloride
02 1Buprenorphine hydrochloride
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 SUBOXONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUBOXONE, including repackagers and relabelers. The FDA regulates SUBOXONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUBOXONE 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 SUBOXONE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SUBOXONE supplier is an individual or a company that provides SUBOXONE active pharmaceutical ingredient (API) or SUBOXONE finished formulations upon request. The SUBOXONE suppliers may include SUBOXONE API manufacturers, exporters, distributors and traders.
click here to find a list of SUBOXONE 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 SUBOXONE Drug Master File in Japan (SUBOXONE JDMF) empowers SUBOXONE 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 SUBOXONE JDMF during the approval evaluation for pharmaceutical products. At the time of SUBOXONE 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 SUBOXONE suppliers with JDMF on PharmaCompass.
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