01 1Zhejiang Hisun Pharmaceutical Co., Ltd.
01 1Ace Biopharm Co., Ltd.
01 1Ivermectin
01 1China
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-02-21
Registration Number : 20250221-211-J-1776
Manufacturer Name : Zhejiang Hisun Pharmaceutica...
Manufacturer Address : 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, People's Republi...
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A Mectizan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mectizan, including repackagers and relabelers. The FDA regulates Mectizan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mectizan 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 Mectizan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Mectizan supplier is an individual or a company that provides Mectizan active pharmaceutical ingredient (API) or Mectizan finished formulations upon request. The Mectizan suppliers may include Mectizan API manufacturers, exporters, distributors and traders.
click here to find a list of Mectizan 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 Mectizan Drug Master File in Korea (Mectizan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mectizan. The MFDS reviews the Mectizan KDMF as part of the drug registration process and uses the information provided in the Mectizan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mectizan 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 Mectizan API can apply through the Korea Drug Master File (KDMF).
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