01 1Apotex Pharmachem India Private Limited.
02 1Hanseochem Co., Ltd.
03 2Hwail Pharmaceutical Co., Ltd.
04 1Kyungdong Pharmaceutical Co., Ltd.
05 1Maithri Drugs Private Limited
06 1Pfizer Ireland Pharmaceuticals
01 1Aging Life Science Co., Ltd.
02 1Hanseochem Co., Ltd.
03 2Hwail Pharmaceutical Co., Ltd.
04 1Korea Pfizer Pharmaceutical Co., Ltd.
05 1Kyungdong Pharmaceutical Co., Ltd.
06 1Samoh Pharmaceutical Co., Ltd.
01 1Varenicline
02 1Varenicline besylate monohydrate
03 1Varenicline fumarate
04 1Varenicline salicylate
05 3Varenicline tartrate
01 1Canada
02 1India
03 4South Korea
04 1U.S.A
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2017-09-25
Registration Number : 207-35-ND
Manufacturer Name : Apotex Pharmachem India Priv...
Manufacturer Address : Plot No. 1A, Bommasandra Industrial Area, 4th Phase, Bommasandra Industrial Estate (P...
Registrant Name : Hanseochem Co., Ltd.
Registration Date : 2018-03-21
Registration Number : 2295-10-ND
Manufacturer Name : Hanseochem Co., Ltd.
Manufacturer Address : 41 Poseung Industrial Complex-ro, Poseung-eup, Pyeongtaek-si, Gyeonggi-do
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2018-10-10
Registration Number : 2014-17-ND
Manufacturer Name : Hwail Pharmaceutical Co., Lt...
Manufacturer Address : 57, Yakjakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2017-12-04
Registration Number : 2014-13-ND
Manufacturer Name : Hwail Pharmaceutical Co., Lt...
Manufacturer Address : 57, Yakjakgongdan 3-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Varenicline besylate monohydrate
Registrant Name : Kyungdong Pharmaceutical Co., Ltd.
Registration Date : 2018-09-10
Registration Number : 1574-3-ND
Manufacturer Name : Kyungdong Pharmaceutical Co....
Manufacturer Address : 15, Balan Industrial Complex Road 2-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-09-17
Registration Number : 434-21-ND
Manufacturer Name : Maithri Drugs Private Limite...
Manufacturer Address : Sy. No. 205, 222 to 226, IDA Bonthapally, Bonthapally(Village), Gummadidala(Mandal), ...
Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.
Registration Date : 2018-08-24
Registration Number : 87-24-ND
Manufacturer Name : Pfizer Ireland Pharmaceutica...
Manufacturer Address : Ringaskiddy API Plant, PO Box 140, Ringaskiddy, Co. Cork, Ireland
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.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Varenicline Drug Master File in Korea (Varenicline KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Varenicline. The MFDS reviews the Varenicline KDMF as part of the drug registration process and uses the information provided in the Varenicline KDMF to evaluate the safety and efficacy of the drug.
After submitting a Varenicline KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Varenicline API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Varenicline suppliers with KDMF on PharmaCompass.
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