Veranova: A CDMO that manages complexity with confidence.
01 1Veranova, LP
01 1GlaxoSmithKline Inc.
01 1Ambrisentan
01 1U.S.A
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-08-22
Registration Number : Su2480-15-ND
Manufacturer Name : Veranova, LP
Manufacturer Address : 25 Patton road, Devens, MA 01434 USA
A Ambrisentan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambrisentan, including repackagers and relabelers. The FDA regulates Ambrisentan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambrisentan 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 Ambrisentan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambrisentan supplier is an individual or a company that provides Ambrisentan active pharmaceutical ingredient (API) or Ambrisentan finished formulations upon request. The Ambrisentan suppliers may include Ambrisentan API manufacturers, exporters, distributors and traders.
click here to find a list of Ambrisentan 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 Ambrisentan Drug Master File in Korea (Ambrisentan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ambrisentan. The MFDS reviews the Ambrisentan KDMF as part of the drug registration process and uses the information provided in the Ambrisentan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ambrisentan 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 Ambrisentan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ambrisentan suppliers with KDMF on PharmaCompass.
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