01 1Alembic Pharmaceuticals Limited
01 1Sungwoo Chemical Co., Ltd.
01 1Prasugrel
01 1India
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2015-12-02
Registration Number : No. 4579-7-ND
Manufacturer Name : Alembic Pharmaceuticals Limi...
Manufacturer Address : Plot No. 842-843, TAL-Padra, City : Karakhadi - 391 450, Dist : Vadodara, Gujarat Sta...
A Prasugrel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prasugrel, including repackagers and relabelers. The FDA regulates Prasugrel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prasugrel 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 Prasugrel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prasugrel supplier is an individual or a company that provides Prasugrel active pharmaceutical ingredient (API) or Prasugrel finished formulations upon request. The Prasugrel suppliers may include Prasugrel API manufacturers, exporters, distributors and traders.
click here to find a list of Prasugrel 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 Prasugrel Drug Master File in Korea (Prasugrel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prasugrel. The MFDS reviews the Prasugrel KDMF as part of the drug registration process and uses the information provided in the Prasugrel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Prasugrel 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 Prasugrel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Prasugrel suppliers with KDMF on PharmaCompass.
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