01 1Pharmacostec Co., Ltd.
02 1Recordati Industria Chimica e Farmaceutica SpA
01 1HKINNOEN Co., Ltd.
02 1Pharmacostec Co., Ltd.
01 1Manidipine hydrochloride
02 1Manidipine hydrochloride (micronized)
01 1South Korea
02 1U.S.A
Registrant Name : Pharmacostec Co., Ltd.
Registration Date : 2023-12-11
Registration Number : 20231211-209-J-1580
Manufacturer Name : Pharmacostec Co., Ltd.
Manufacturer Address : Block 35-2, Balan Local Industrial Complex, 47, Pharmaceutical Complex, Hyangnam-eup,...
Manidipine hydrochloride (micronized)
Registrant Name : HKINNOEN Co., Ltd.
Registration Date : 2021-05-18
Registration Number : 20210518-209-J-801
Manufacturer Name : Recordati Industria Chimica ...
Manufacturer Address : Via Mediana Cisterna, 4, 04011 Campoverde di Aprilia (LT) - Italy
A Manidipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Manidipine, including repackagers and relabelers. The FDA regulates Manidipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Manidipine 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 Manidipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Manidipine supplier is an individual or a company that provides Manidipine active pharmaceutical ingredient (API) or Manidipine finished formulations upon request. The Manidipine suppliers may include Manidipine API manufacturers, exporters, distributors and traders.
click here to find a list of Manidipine 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 Manidipine Drug Master File in Korea (Manidipine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Manidipine. The MFDS reviews the Manidipine KDMF as part of the drug registration process and uses the information provided in the Manidipine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Manidipine 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 Manidipine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Manidipine suppliers with KDMF on PharmaCompass.
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