01 1Esteve Quimica, SA
02 1Yuhan Chemical
01 2Gilead Sciences Korea Ltd.
01 2Ledipasvir
01 1South Korea
02 1Spain
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2015-10-12
Registration Number : Su6273-5-ND
Manufacturer Name : Esteve Quimica, SA
Manufacturer Address : C/ Ter, 94 Polígon Industrial 17460 Celrà (Girona), Spain
Registrant Name : Gilead Sciences Korea Ltd.
Registration Date : 2015-08-26
Registration Number : Su6273-3-ND
Manufacturer Name : Yuhan Chemical
Manufacturer Address : 45 Jiwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do
64
PharmaCompass offers a list of Ledipasvir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ledipasvir manufacturer or Ledipasvir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ledipasvir manufacturer or Ledipasvir supplier.
A Ledipasvir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ledipasvir, including repackagers and relabelers. The FDA regulates Ledipasvir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ledipasvir 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 Ledipasvir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ledipasvir supplier is an individual or a company that provides Ledipasvir active pharmaceutical ingredient (API) or Ledipasvir finished formulations upon request. The Ledipasvir suppliers may include Ledipasvir API manufacturers, exporters, distributors and traders.
click here to find a list of Ledipasvir 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 Ledipasvir Drug Master File in Korea (Ledipasvir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ledipasvir. The MFDS reviews the Ledipasvir KDMF as part of the drug registration process and uses the information provided in the Ledipasvir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ledipasvir 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 Ledipasvir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ledipasvir suppliers with KDMF on PharmaCompass.
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