01 1Mac-Chem Products (India) Pvt.Ltd.
01 1(주)에스지바이오켐
01 1Hydrocortisone sodium succinate
01 1India
Hydrocortisone sodium succinate
Registrant Name : (주)에스지바이오켐
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
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PharmaCompass offers a list of Hydrocortisone Sodium Succinate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Hydrocortisone Sodium Succinate manufacturer or Hydrocortisone Sodium Succinate supplier for your needs.
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A Solu-Cortef manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Solu-Cortef, including repackagers and relabelers. The FDA regulates Solu-Cortef manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Solu-Cortef API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Solu-Cortef supplier is an individual or a company that provides Solu-Cortef active pharmaceutical ingredient (API) or Solu-Cortef finished formulations upon request. The Solu-Cortef suppliers may include Solu-Cortef API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Solu-Cortef Drug Master File in Korea (Solu-Cortef KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Solu-Cortef. The MFDS reviews the Solu-Cortef KDMF as part of the drug registration process and uses the information provided in the Solu-Cortef KDMF to evaluate the safety and efficacy of the drug.
After submitting a Solu-Cortef 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 Solu-Cortef API can apply through the Korea Drug Master File (KDMF).
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