Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 3Farmak, as
02 1Sanofi Chimie
03 2Centaur Pharmaceuticals Pvt. Ltd
04 2Centaur Pharmaceuticals Pvt. Ltd.
05 1Tianish Laboratories Private Limited (Unit-1)
01 2Hanapharmaceutical Co., Ltd.
02 1Handok Co., Ltd.
03 1Hanmi Pharmaceutical Co., Ltd.
04 2Hwanin Pharmaceutical Co., Ltd.
05 1Korea Pharma Co., Ltd.
06 1Korea Pharmaceutical Co., Ltd.
07 1Sungjin Exim Co., Ltd.
01 9Zolpidem tartrate
01 3Czech Republic
02 1France
03 4India
04 1U.S.A
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registrant Name : Korea Pharmaceutical Co., Ltd.
Registration Date : 2021-03-09
Registration Number : 20200515-209-J-477(2)
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-03-22
Registration Number : 20210322-209-J-901
Manufacturer Name : Sanofi Chimie
Manufacturer Address : 45, chemin de Météline Boîte Postale 15 04201 Sisteron Cedex, France
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2020-09-04
Registration Number : 20200515-209-J-477(1)
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2020-05-15
Registration Number : 20200515-209-J-477
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Registrant Name : Hanapharmaceutical Co., Ltd.
Registration Date : 2024-01-05
Registration Number : 20210727-209-J-1081(A)
Manufacturer Name : Centaur Pharmaceuticals Pvt....
Manufacturer Address : Plot no. 75,76 & 76/1, Chikhloli MIDC Ambernath (West) Dist. Thane – 421 501, Mahar...
Registrant Name : Hanapharmaceutical Co., Ltd.
Registration Date : 2022-01-12
Registration Number : 20210727-209-J-1081(1)
Manufacturer Name : Centaur Pharmaceuticals Pvt....
Manufacturer Address : Plot no. 75,76 & 76/1, Chikhloli MIDC Ambernath (West) Dist. Thane – 421 501, Mahar...
Registrant Name : Hwanin Pharmaceutical Co., Ltd.
Registration Date : 2023-02-03
Registration Number : 20210727-209-J-1081(2)
Manufacturer Name : Centaur Pharmaceuticals Pvt....
Manufacturer Address : Plot No. 75, 76 & 76/1, Chikhloli MIDC Ambernath (West), District: Thane - 421 501, M...
Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2021-07-27
Registration Number : 20210727-209-J-1081
Manufacturer Name : Centaur Pharmaceuticals Pvt....
Manufacturer Address : Plot No. 75, 76 & 76/1, Chikhloli MIDC Ambernath (West), District: Thane - 421 501, M...
Registrant Name : Korea Pharma Co., Ltd.
Registration Date : 2021-05-13
Registration Number : 20210513-209-J-986
Manufacturer Name : Tianish Laboratories Private...
Manufacturer Address : Survey No. 10, Gaddapotharam Kazipally Industrial Area Sangareddy District-502319 Tel...
A Zolpidem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zolpidem, including repackagers and relabelers. The FDA regulates Zolpidem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zolpidem 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 Zolpidem manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zolpidem supplier is an individual or a company that provides Zolpidem active pharmaceutical ingredient (API) or Zolpidem finished formulations upon request. The Zolpidem suppliers may include Zolpidem API manufacturers, exporters, distributors and traders.
click here to find a list of Zolpidem 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 Zolpidem Drug Master File in Korea (Zolpidem KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zolpidem. The MFDS reviews the Zolpidem KDMF as part of the drug registration process and uses the information provided in the Zolpidem KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zolpidem 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 Zolpidem API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Zolpidem suppliers with KDMF on PharmaCompass.
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