Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem Dunkerque Production
02 2Metrochem API Private Limited
03 1AstraZeneca AB
04 1Glenmark Pharmaceuticals Limited
05 1Sun Pharmaceutical Industries Ltd.@[Partial Process Outsourcing (Manufacturer)_Stage Ⅰ]Sun Pharmaceutical Industries Ltd.
06 1UNION QUIMICO FARMACEUTICA, SA
07 1Union Quimico Farmaceutica, SA
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Registrant Name : AstraZeneca Korea Ltd.
Registration Date : 2011-11-04
Registration Number : 20111104-127-H-192-07
Manufacturer Name : Minakem Dunkerque Production
Manufacturer Address : 224 avenue de la Dordogne Zone d'Entreprises du Nord Gracht 59640 Dunkerque, France
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2019-11-05
Registration Number : 20171031-127-H-320-29(2)
Manufacturer Name : Metrochem API Private Limite...
Manufacturer Address : Unit-Ⅰ, Plot. No. 62/C/6, Pipeline Road Phase-I, IDA, Jeedimetla, Quthbullapur Mand...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Registrant Name : Hiple Co., Ltd.
Registration Date : 2017-10-31
Registration Number : 20171031-127-H-320-29
Manufacturer Name : Metrochem API Private Limite...
Manufacturer Address : Unit-Ⅰ, Plot. No. 62/C/6, Pipeline Road Phase-I, IDA, Jeedimetla, Quthbullapur Mand...
A Esomeprazole Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Esomeprazole Sodium, including repackagers and relabelers. The FDA regulates Esomeprazole Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Esomeprazole Sodium 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 Esomeprazole Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Esomeprazole Sodium supplier is an individual or a company that provides Esomeprazole Sodium active pharmaceutical ingredient (API) or Esomeprazole Sodium finished formulations upon request. The Esomeprazole Sodium suppliers may include Esomeprazole Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Esomeprazole Sodium 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 Esomeprazole Sodium Drug Master File in Korea (Esomeprazole Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Esomeprazole Sodium. The MFDS reviews the Esomeprazole Sodium KDMF as part of the drug registration process and uses the information provided in the Esomeprazole Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Esomeprazole Sodium 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 Esomeprazole Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Esomeprazole Sodium suppliers with KDMF on PharmaCompass.
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