01 1Apothecon Pharmaceuticals Pvt. Ltd.
02 1Lusochimica SpA
01 1Agerson Bio Co., Ltd.
02 1Samoh Pharmaceutical Co., Ltd.
01 2Nicardipine hydrochloride
01 1India
02 1Italy
Registrant Name : Agerson Bio Co., Ltd.
Registration Date : 2023-04-04
Registration Number : 20230404-210-J-1467
Manufacturer Name : Apothecon Pharmaceuticals Pv...
Manufacturer Address : PLOT NO 1134, 1135, 1136, 1137, 1143B, 1144 A&B, 1138 A&B, Padra Jambusar Highway, Ta...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-08-09
Registration Number : 20230809-210-J-1488
Manufacturer Name : Lusochimica SpA
Manufacturer Address : Via Giotto 9, 23871 Lomagna (LC), Italy
A Nicardipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nicardipine, including repackagers and relabelers. The FDA regulates Nicardipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nicardipine 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 Nicardipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nicardipine supplier is an individual or a company that provides Nicardipine active pharmaceutical ingredient (API) or Nicardipine finished formulations upon request. The Nicardipine suppliers may include Nicardipine API manufacturers, exporters, distributors and traders.
click here to find a list of Nicardipine 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 Nicardipine Drug Master File in Korea (Nicardipine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nicardipine. The MFDS reviews the Nicardipine KDMF as part of the drug registration process and uses the information provided in the Nicardipine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Nicardipine 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 Nicardipine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Nicardipine suppliers with KDMF on PharmaCompass.
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