01 1[Intermediate 3 and raw pharmaceutical product manufacturing] AbbVie Srl@ [Intermediate L and Intermediate 2 manufacturing] Jilin Asymchem Laboratories Co., Ltd@ [Intermediate 1 manufacturing] Lundbeck Pharmaceuticals Italy SpA
02 1[Intermediate 3 and raw pharmaceutical product manufacturing] Abbvie Ireland NL BV@[Intermediate 1 manufacturing] Lundbeck Pharmaceuticals Italy SpA@[Intermediate L and Intermediate 2 manufacturing] Jilin Asymchem Laboratories Co., Ltd
01 2AbbVie Korea Inc.
01 2Glecaprevir
01 2U.S.A
Registrant Name : AbbVie Korea Inc.
Registration Date : 2018-06-27
Registration Number : Su325-9-ND
Manufacturer Name : [Intermediate 3 and raw phar...
Manufacturer Address : [Intermediate 3 and raw pharmaceutical product manufacturing]SR 148 Pontina, km 52 Sn...
Registrant Name : AbbVie Korea Inc.
Registration Date : 2017-12-15
Registration Number : Su325-7-ND
Manufacturer Name : [Intermediate 3 and raw phar...
Manufacturer Address : Manorhamilton Road, Sligo, Ireland@Zona Industriale Quarta Strada 2 Stab. To Ang. Via...
A Glecaprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glecaprevir, including repackagers and relabelers. The FDA regulates Glecaprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glecaprevir 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 Glecaprevir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glecaprevir supplier is an individual or a company that provides Glecaprevir active pharmaceutical ingredient (API) or Glecaprevir finished formulations upon request. The Glecaprevir suppliers may include Glecaprevir API manufacturers, exporters, distributors and traders.
click here to find a list of Glecaprevir 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 Glecaprevir Drug Master File in Korea (Glecaprevir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Glecaprevir. The MFDS reviews the Glecaprevir KDMF as part of the drug registration process and uses the information provided in the Glecaprevir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Glecaprevir 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 Glecaprevir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Glecaprevir suppliers with KDMF on PharmaCompass.
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