01 1Zydus Lifesciences Limited
01 1MPK Korea Co., Ltd.
01 1Benzoyl peroxide
01 1India
Registrant Name : MPK Korea Co., Ltd.
Registration Date : 2025-09-16
Registration Number : 20250916-211-J-2023
Manufacturer Name : Zydus Lifesciences Limited
Manufacturer Address : Plot No. 291, GIDC Estate, City - Ankleshwar - 393 002, Dist. - Bharuch, Gujarat Stat...
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A ONEXTON manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ONEXTON, including repackagers and relabelers. The FDA regulates ONEXTON manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ONEXTON 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 ONEXTON manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ONEXTON supplier is an individual or a company that provides ONEXTON active pharmaceutical ingredient (API) or ONEXTON finished formulations upon request. The ONEXTON suppliers may include ONEXTON API manufacturers, exporters, distributors and traders.
click here to find a list of ONEXTON 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 ONEXTON Drug Master File in Korea (ONEXTON KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ONEXTON. The MFDS reviews the ONEXTON KDMF as part of the drug registration process and uses the information provided in the ONEXTON KDMF to evaluate the safety and efficacy of the drug.
After submitting a ONEXTON 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 ONEXTON API can apply through the Korea Drug Master File (KDMF).
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