01 1Cerbios Pharma SA@[Spray Drying Plant] Micro-Sphere SA
01 1MediHelpline Co., Ltd.
01 1Tiotropium bromide
01 1Switzerland
Registrant Name : MediHelpline Co., Ltd.
Registration Date : 2019-08-01
Registration Number : 20190801-211-J-399
Manufacturer Name : Cerbios Pharma SA@[Spray Dry...
Manufacturer Address : Via Figino 6, 6917 Barbengo, Switzerland@[Spray drying factory]Via Cantonale 77, 6998...
A Tiotropium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tiotropium, including repackagers and relabelers. The FDA regulates Tiotropium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tiotropium 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 Tiotropium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tiotropium supplier is an individual or a company that provides Tiotropium active pharmaceutical ingredient (API) or Tiotropium finished formulations upon request. The Tiotropium suppliers may include Tiotropium API manufacturers, exporters, distributors and traders.
click here to find a list of Tiotropium 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 Tiotropium Drug Master File in Korea (Tiotropium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tiotropium. The MFDS reviews the Tiotropium KDMF as part of the drug registration process and uses the information provided in the Tiotropium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tiotropium 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 Tiotropium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tiotropium suppliers with KDMF on PharmaCompass.
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