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 Lekoptin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lekoptin, including repackagers and relabelers. The FDA regulates Lekoptin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lekoptin 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 Lekoptin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lekoptin supplier is an individual or a company that provides Lekoptin active pharmaceutical ingredient (API) or Lekoptin finished formulations upon request. The Lekoptin suppliers may include Lekoptin API manufacturers, exporters, distributors and traders.
click here to find a list of Lekoptin 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 Lekoptin Drug Master File in Korea (Lekoptin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lekoptin. The MFDS reviews the Lekoptin KDMF as part of the drug registration process and uses the information provided in the Lekoptin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lekoptin 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 Lekoptin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lekoptin suppliers with KDMF on PharmaCompass.
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