01 1Korea Biochem Pharmaceutical Co., Ltd.
02 1Lonza AG
03 1PLIVA Croatia Ltd
04 1SK Biotek Ireland Limited
01 2AstraZeneca Korea Ltd.
02 1Korea Biochem Pharmaceutical Co., Ltd.
03 1Samoh Pharmaceutical Co., Ltd.
01 2Saxagliptin hydrate
02 2Saxagliptin monohydrate
01 1Croatia
02 1South Korea
03 2U.S.A
Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.
Registration Date : 2024-04-03
Registration Number : 2152-23-ND
Manufacturer Name : Korea Biochem Pharmaceutical...
Manufacturer Address : Korea Biochem Pharmaceutical Co., Ltd. 204 Sandan-gil, Jeonui-myeon, Sejong Special S...
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2019-12-23
Registration Number : Su248-13-ND
Manufacturer Name : Lonza AG
Manufacturer Address : Lonzastrasse, 3930 Visp, Switzerland
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2017-06-09
Registration Number : 207-34-ND
Manufacturer Name : PLIVA Croatia Ltd
Manufacturer Address : 10291 Prigorje Brdovecko, Prudnicka cesta 54, Republic of Croatia
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2011-01-10
Registration Number : Su335-5-ND
Manufacturer Name : SK Biotek Ireland Limited
Manufacturer Address : Watery Lane, Swords, Co. Dublin, K67 AY91, Ireland
A Saxagliptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Saxagliptin, including repackagers and relabelers. The FDA regulates Saxagliptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Saxagliptin 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 Saxagliptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Saxagliptin supplier is an individual or a company that provides Saxagliptin active pharmaceutical ingredient (API) or Saxagliptin finished formulations upon request. The Saxagliptin suppliers may include Saxagliptin API manufacturers, exporters, distributors and traders.
click here to find a list of Saxagliptin 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 Saxagliptin Drug Master File in Korea (Saxagliptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Saxagliptin. The MFDS reviews the Saxagliptin KDMF as part of the drug registration process and uses the information provided in the Saxagliptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Saxagliptin 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 Saxagliptin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Saxagliptin suppliers with KDMF on PharmaCompass.
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