AMI Lifesciences is Driven by Chemistry. Powered by People.
01 1Ami Lifesciences Private Limited
02 1Sumitomo Chemicals Co., Ltd. Gifu Plant, Oita Works
01 1Aging Life Science Co., Ltd.
02 1Jeil Pharmaceutical Co., Ltd.
01 2Vibegron
01 1India
02 1Japan
AMI Lifesciences is Driven by Chemistry. Powered by People.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2024-11-07
Registration Number : 434-69-ND
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi – 391 45...
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2022-10-31
Registration Number : Su216-24-ND
Manufacturer Name : Sumitomo Chemicals Co., Ltd....
Manufacturer Address : 3750, Azajuhachicho, Maki, Ampachicho, Ampachi-Gun, Gifu 503-0125, Japan
A Vibegron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vibegron, including repackagers and relabelers. The FDA regulates Vibegron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vibegron 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 Vibegron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vibegron supplier is an individual or a company that provides Vibegron active pharmaceutical ingredient (API) or Vibegron finished formulations upon request. The Vibegron suppliers may include Vibegron API manufacturers, exporters, distributors and traders.
click here to find a list of Vibegron 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 Vibegron Drug Master File in Korea (Vibegron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vibegron. The MFDS reviews the Vibegron KDMF as part of the drug registration process and uses the information provided in the Vibegron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vibegron 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 Vibegron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vibegron suppliers with KDMF on PharmaCompass.
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