01 1Cipla Limited.
01 1Pharmapia Co., Ltd.
01 1Ambrisentan
01 1India
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2025-02-18
Registration Number : Su258-30-ND
Manufacturer Name : Cipla Limited.
Manufacturer Address : Plot Nos. A-2, A-33 & A-37/2/2,MIDC, Patalganga, Raigad 410220 Maharashtra State, Ind...
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A Volibris manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Volibris, including repackagers and relabelers. The FDA regulates Volibris manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Volibris 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 Volibris manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Volibris supplier is an individual or a company that provides Volibris active pharmaceutical ingredient (API) or Volibris finished formulations upon request. The Volibris suppliers may include Volibris API manufacturers, exporters, distributors and traders.
click here to find a list of Volibris 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 Volibris Drug Master File in Korea (Volibris KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Volibris. The MFDS reviews the Volibris KDMF as part of the drug registration process and uses the information provided in the Volibris KDMF to evaluate the safety and efficacy of the drug.
After submitting a Volibris 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 Volibris API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Volibris suppliers with KDMF on PharmaCompass.
