01 1Mac-Chem Products (India) Pvt.Ltd.
01 1SG Biochem Co., Ltd.
01 1sodium hydrocortisone succinate
01 1India
sodium hydrocortisone succinate
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2025-03-07
Registration Number : 20250307-210-J-1693
Manufacturer Name : Mac-Chem Products (India) Pv...
Manufacturer Address : N-211/2/10, MIDC, Boisar, Dist. Palghar 401 506, State Maharashtra, India
49
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A Rapicort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rapicort, including repackagers and relabelers. The FDA regulates Rapicort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rapicort 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 Rapicort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rapicort supplier is an individual or a company that provides Rapicort active pharmaceutical ingredient (API) or Rapicort finished formulations upon request. The Rapicort suppliers may include Rapicort API manufacturers, exporters, distributors and traders.
click here to find a list of Rapicort 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 Rapicort Drug Master File in Korea (Rapicort KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rapicort. The MFDS reviews the Rapicort KDMF as part of the drug registration process and uses the information provided in the Rapicort KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rapicort 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 Rapicort API can apply through the Korea Drug Master File (KDMF).
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