01 1Nippon Rika Co., Ltd. Ashikaga Plant
02 1Nippon Rika Co., Ltd. Ashikaga Plant@KYORIN Pharmaceutical Group Facilities Co., Ltd. Noshiro Plant
01 2Handok Co., Ltd.
01 2Ibudilast
01 2Japan
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-08-20
Registration Number : 20210820-209-J-1095
Manufacturer Name : Nippon Rika Co., Ltd. Ashika...
Manufacturer Address : 610, Yanada-cho, Ashikaga-shi, Tochigi 326-0321, Japan@1, Matsubara, Noshiro-shi, Aki...
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-07-29
Registration Number : 20210729-209-J-1082
Manufacturer Name : Nippon Rika Co., Ltd. Ashika...
Manufacturer Address : 610, Yanada-cho, Ashikaga-shi, Tochigi 326-0321, Japan
A Ibudilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibudilast, including repackagers and relabelers. The FDA regulates Ibudilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibudilast 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 Ibudilast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibudilast supplier is an individual or a company that provides Ibudilast active pharmaceutical ingredient (API) or Ibudilast finished formulations upon request. The Ibudilast suppliers may include Ibudilast API manufacturers, exporters, distributors and traders.
click here to find a list of Ibudilast 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 Ibudilast Drug Master File in Korea (Ibudilast KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ibudilast. The MFDS reviews the Ibudilast KDMF as part of the drug registration process and uses the information provided in the Ibudilast KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ibudilast 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 Ibudilast API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ibudilast suppliers with KDMF on PharmaCompass.
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