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 Letairis manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Letairis, including repackagers and relabelers. The FDA regulates Letairis manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Letairis 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 Letairis manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Letairis supplier is an individual or a company that provides Letairis active pharmaceutical ingredient (API) or Letairis finished formulations upon request. The Letairis suppliers may include Letairis API manufacturers, exporters, distributors and traders.
click here to find a list of Letairis 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 Letairis Drug Master File in Korea (Letairis KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Letairis. The MFDS reviews the Letairis KDMF as part of the drug registration process and uses the information provided in the Letairis KDMF to evaluate the safety and efficacy of the drug.
After submitting a Letairis 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 Letairis API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Letairis suppliers with KDMF on PharmaCompass.
