01 3PolyPeptide Laboratories (Sweden) AB
01 1Dongkook Pharmaceutical Co., Ltd.
02 1Hanlim Pharmaceutical Co., Ltd.
03 1Korea Ferring Pharmaceutical Co., Ltd.
01 3Atosiban
01 3Switzerland
Registrant Name : Dongkook Pharmaceutical Co., Ltd.
Registration Date : 2015-03-30
Registration Number : 20121121-192-I-106-01(1)
Manufacturer Name : PolyPeptide Laboratories (Sw...
Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn, Sweden
Registrant Name : Korea Ferring Pharmaceutical Co., Ltd.
Registration Date : 2012-11-21
Registration Number : 20121121-192-I-106-01
Manufacturer Name : PolyPeptide Laboratories (Sw...
Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn
Registrant Name : Hanlim Pharmaceutical Co., Ltd.
Registration Date : 2015-09-09
Registration Number : 20121121-192-I-106-01(2)
Manufacturer Name : PolyPeptide Laboratories (Sw...
Manufacturer Address : Hogerudsgatan 21 SE-216 13 Limhamn
A Atosiban manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Atosiban, including repackagers and relabelers. The FDA regulates Atosiban manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Atosiban 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 Atosiban manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Atosiban supplier is an individual or a company that provides Atosiban active pharmaceutical ingredient (API) or Atosiban finished formulations upon request. The Atosiban suppliers may include Atosiban API manufacturers, exporters, distributors and traders.
click here to find a list of Atosiban 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 Atosiban Drug Master File in Korea (Atosiban KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Atosiban. The MFDS reviews the Atosiban KDMF as part of the drug registration process and uses the information provided in the Atosiban KDMF to evaluate the safety and efficacy of the drug.
After submitting a Atosiban 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 Atosiban API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Atosiban suppliers with KDMF on PharmaCompass.
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