01 1Lee Pharma Limited
01 1Varenicline Tartrate
01 1India
Registration Number : 303MF10142
Registrant's Address : SY, No. :257 & 258/1, Door No: 11-6/56-C, Opp: IDPL Factory, Moosapet, Balanagar (Pos...
Initial Date of Registration : 2021-09-02
Latest Date of Registration : 2021-09-02
A Varenicline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Varenicline, including repackagers and relabelers. The FDA regulates Varenicline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Varenicline 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 Varenicline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Varenicline supplier is an individual or a company that provides Varenicline active pharmaceutical ingredient (API) or Varenicline finished formulations upon request. The Varenicline suppliers may include Varenicline API manufacturers, exporters, distributors and traders.
click here to find a list of Varenicline 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 Varenicline Drug Master File in Japan (Varenicline JDMF) empowers Varenicline 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 Varenicline JDMF during the approval evaluation for pharmaceutical products. At the time of Varenicline 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 Varenicline suppliers with JDMF on PharmaCompass.
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