01 1RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA
01 1Ilsung IS Co., Ltd.
01 1Verapamil hydrochloride
01 1U.S.A
Registrant Name : Ilsung IS Co., Ltd.
Registration Date : 2021-06-22
Registration Number : 20210622-209-J-1032
Manufacturer Name : RECORDATI INDUSTRIA CHIMICA ...
Manufacturer Address : Via Mediana Cisterna, 4 - 04011 APRILIA (LT)
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A Isoptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isoptin, including repackagers and relabelers. The FDA regulates Isoptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isoptin 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 Isoptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Isoptin supplier is an individual or a company that provides Isoptin active pharmaceutical ingredient (API) or Isoptin finished formulations upon request. The Isoptin suppliers may include Isoptin API manufacturers, exporters, distributors and traders.
click here to find a list of Isoptin suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Isoptin Drug Master File in Korea (Isoptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isoptin. The MFDS reviews the Isoptin KDMF as part of the drug registration process and uses the information provided in the Isoptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isoptin 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 Isoptin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isoptin suppliers with KDMF on PharmaCompass.
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