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 Onglyza Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Onglyza Hydrate, including repackagers and relabelers. The FDA regulates Onglyza Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Onglyza Hydrate 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 Onglyza Hydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Onglyza Hydrate supplier is an individual or a company that provides Onglyza Hydrate active pharmaceutical ingredient (API) or Onglyza Hydrate finished formulations upon request. The Onglyza Hydrate suppliers may include Onglyza Hydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Onglyza Hydrate 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 Onglyza Hydrate Drug Master File in Korea (Onglyza Hydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Onglyza Hydrate. The MFDS reviews the Onglyza Hydrate KDMF as part of the drug registration process and uses the information provided in the Onglyza Hydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Onglyza Hydrate 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 Onglyza Hydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Onglyza Hydrate suppliers with KDMF on PharmaCompass.
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