01 1[Raw material pharmaceutical manufacturing] Abbvie Ireland NL BV@[Intermediate 1-5 manufacturing] Procos SpA
02 1AbbVie Srl
01 1AbbVie Korea Co., Ltd.
02 1AbbVie Korea Inc.
01 2Pibrentasvir
01 1Italy
02 1U.S.A
Registrant Name : AbbVie Korea Inc.
Registration Date : 2017-12-15
Registration Number : Su325-8-ND
Manufacturer Name : [Raw material pharmaceutical...
Manufacturer Address : Manorhamilton Road, Sligo, Ireland@Via Matteotti, 249 28062 Cameri(NO), Italy
Registrant Name : AbbVie Korea Co., Ltd.
Registration Date : 2020-10-08
Registration Number : Su325-13-ND
Manufacturer Name : AbbVie Srl
Manufacturer Address : SR 148 Pontina km 52, Snc - Campoverde di Aprilia, 04011 Aprilia (LT), Italy
A Pibrentasvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pibrentasvir, including repackagers and relabelers. The FDA regulates Pibrentasvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pibrentasvir 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 Pibrentasvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pibrentasvir supplier is an individual or a company that provides Pibrentasvir active pharmaceutical ingredient (API) or Pibrentasvir finished formulations upon request. The Pibrentasvir suppliers may include Pibrentasvir API manufacturers, exporters, distributors and traders.
click here to find a list of Pibrentasvir 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 Pibrentasvir Drug Master File in Korea (Pibrentasvir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Pibrentasvir. The MFDS reviews the Pibrentasvir KDMF as part of the drug registration process and uses the information provided in the Pibrentasvir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Pibrentasvir 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 Pibrentasvir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Pibrentasvir suppliers with KDMF on PharmaCompass.
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