01 1Alembic Pharmaceuticals Limited
01 1Seongwoo Chemical Co., Ltd.
01 1Prasugrel
01 1India
Registrant Name : Seongwoo Chemical Co., Ltd.
Registration Date : 2015-12-02
Registration Number : Su4579-7-ND
Manufacturer Name : Alembic Pharmaceuticals Limi...
Manufacturer Address : Plot No. 842-843, TAL-Padra, City : Karakhadi - 391 450, Dist : Vadodara, Gujarat Sta...
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A Effient manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Effient, including repackagers and relabelers. The FDA regulates Effient manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Effient 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 Effient manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Effient supplier is an individual or a company that provides Effient active pharmaceutical ingredient (API) or Effient finished formulations upon request. The Effient suppliers may include Effient API manufacturers, exporters, distributors and traders.
click here to find a list of Effient suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Effient Drug Master File in Korea (Effient KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Effient. The MFDS reviews the Effient KDMF as part of the drug registration process and uses the information provided in the Effient KDMF to evaluate the safety and efficacy of the drug.
After submitting a Effient 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 Effient API can apply through the Korea Drug Master File (KDMF).
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