01 1BGP Healthcare Pvt. Ltd
02 1Siegfried Ltd
01 2Nicotine
01 1India
02 1Switzerland
Registration Number : 303MF10099
Registrant's Address : Plot No. 3707, GIDC, Ankleshwar 393 002, Bharuch Dist. Gujarat State, India
Initial Date of Registration : 2021-07-01
Latest Date of Registration : 2022-10-26
Registration Number : 219MF10004
Registrant's Address : Untere Bru(¨)hlstrasse 4,CH-4800 Zofingen Switzerland
Initial Date of Registration : 2007-01-18
Latest Date of Registration : 2016-12-26
A (-)-Nicotine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Nicotine, including repackagers and relabelers. The FDA regulates (-)-Nicotine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Nicotine 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 (-)-Nicotine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (-)-Nicotine supplier is an individual or a company that provides (-)-Nicotine active pharmaceutical ingredient (API) or (-)-Nicotine finished formulations upon request. The (-)-Nicotine suppliers may include (-)-Nicotine API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Nicotine 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 (-)-Nicotine Drug Master File in Japan ((-)-Nicotine JDMF) empowers (-)-Nicotine 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 (-)-Nicotine JDMF during the approval evaluation for pharmaceutical products. At the time of (-)-Nicotine 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 (-)-Nicotine suppliers with JDMF on PharmaCompass.
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