01 1AMSA - ANONIMA MATERIE SINTETICHE & AFFINI SPA
01 1Donghwa Pharmaceutical Co., Ltd.
01 1Metoclopramide
01 1Italy
Registrant Name : Donghwa Pharmaceutical Co., Ltd.
Registration Date : 2022-03-17
Registration Number : 20220317-209-J-1251
Manufacturer Name : AMSA - ANONIMA MATERIE SINTE...
Manufacturer Address : VIA G. di VITTORIO, 6 - 22100 COMO (CO)
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A Gastrobid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gastrobid, including repackagers and relabelers. The FDA regulates Gastrobid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gastrobid 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 Gastrobid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Gastrobid supplier is an individual or a company that provides Gastrobid active pharmaceutical ingredient (API) or Gastrobid finished formulations upon request. The Gastrobid suppliers may include Gastrobid API manufacturers, exporters, distributors and traders.
click here to find a list of Gastrobid 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 Gastrobid Drug Master File in Korea (Gastrobid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gastrobid. The MFDS reviews the Gastrobid KDMF as part of the drug registration process and uses the information provided in the Gastrobid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gastrobid 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 Gastrobid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gastrobid suppliers with KDMF on PharmaCompass.
