01 1Glaxo Wellcome Manufacturing Pte Ltd@[micronization process manufacturing company] Glaxo Operations UK Ltd
01 1GlaxoSmithKline Inc.
01 1Eumeclidinium bromide
01 1United Kingdom
Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2014-07-01
Registration Number : Su2480-13-ND
Manufacturer Name : Glaxo Wellcome Manufacturing...
Manufacturer Address : 1 Pioneer Sector 1, Singapore 628413@Priory Street, Ware, Hertfordshire, SG12 0DJ, Un...
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A ANORO ELLIPTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ANORO ELLIPTA, including repackagers and relabelers. The FDA regulates ANORO ELLIPTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ANORO ELLIPTA 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 ANORO ELLIPTA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ANORO ELLIPTA supplier is an individual or a company that provides ANORO ELLIPTA active pharmaceutical ingredient (API) or ANORO ELLIPTA finished formulations upon request. The ANORO ELLIPTA suppliers may include ANORO ELLIPTA API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ANORO ELLIPTA Drug Master File in Korea (ANORO ELLIPTA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ANORO ELLIPTA. The MFDS reviews the ANORO ELLIPTA KDMF as part of the drug registration process and uses the information provided in the ANORO ELLIPTA KDMF to evaluate the safety and efficacy of the drug.
After submitting a ANORO ELLIPTA 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 ANORO ELLIPTA API can apply through the Korea Drug Master File (KDMF).
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