01 1MSN Pharmachem Private Limited
02 1ORIL Industry
03 2Symed Labs Limited
01 1Aging Life Science Co., Ltd.
02 1Hiple Co., Ltd.
03 1Korea Serviette Co., Ltd.
04 1Pharmapia Co., Ltd.
01 4agomelatine
01 1France
02 1India
03 2Malaysia
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2023-10-05
Registration Number : 434-59-ND
Manufacturer Name : MSN Pharmachem Private Limit...
Manufacturer Address : Plot No. 212/A, B, C, D, Phase-II, IDA Pashamylaram, Pashamylaram(Village), Patancher...
Registrant Name : Korea Serviette Co., Ltd.
Registration Date : 2010-05-27
Registration Number : Su3056-1-ND
Manufacturer Name : ORIL Industry
Manufacturer Address : 13, rue Auguste Desgenetais, BOLBEC, 76210, France
Registrant Name : Hiple Co., Ltd.
Registration Date : 2016-12-02
Registration Number : Su50-1-ND
Manufacturer Name : Symed Labs Limited
Manufacturer Address : UNIT-II, Plot No. 25/B, Phase-III, IDA, Jeedimetla (Village), Quthbullapur (Mandal), ...
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2021-04-16
Registration Number : Su50-1-ND(1)
Manufacturer Name : Symed Labs Limited
Manufacturer Address : Plot No.25/B, Phase-III, IDA Jeedimetla Hyderabad-500 055, Telangana State, India
A Agomelatine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Agomelatine, including repackagers and relabelers. The FDA regulates Agomelatine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Agomelatine 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 Agomelatine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Agomelatine supplier is an individual or a company that provides Agomelatine active pharmaceutical ingredient (API) or Agomelatine finished formulations upon request. The Agomelatine suppliers may include Agomelatine API manufacturers, exporters, distributors and traders.
click here to find a list of Agomelatine 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 Agomelatine Drug Master File in Korea (Agomelatine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Agomelatine. The MFDS reviews the Agomelatine KDMF as part of the drug registration process and uses the information provided in the Agomelatine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Agomelatine 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 Agomelatine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Agomelatine suppliers with KDMF on PharmaCompass.
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