01 1(주)국전약품@[조품만주조소]Zhejiang Zhebang Pharmaceutical Co., Ltd.
02 1Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.
03 1Shanghai New Hualian Pharmaceutical Co.,Ltd
01 1Ace Biopharm Co., Ltd.
02 1Eltek Pharmachem Co., Ltd.
03 1Kukjeon Pharmaceutical Co., Ltd.
01 3Isotretinoin
01 2China
02 1South Korea
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2017-12-26
Registration Number : 20171226-209-J-4
Manufacturer Name : Chongqing Huapont Shengchem ...
Manufacturer Address : No. 666 Rongjun Road, Nanjin Avenue Hechuan District, Chongqing China
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2019-03-27
Registration Number : 20190327-209-J-207
Manufacturer Name : (주)국전약품@[조품만...
Manufacturer Address : 8@No.3 , Balan Industrial Complex Road, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Weiwu...
Registrant Name : Eltek Pharmachem Co., Ltd.
Registration Date : 2018-07-12
Registration Number : 20180712-209-J-72
Manufacturer Name : Shanghai New Hualian Pharmac...
Manufacturer Address : No.217, Minle Road, Development Zone, Haiwan Town, Fengxian District, Shanghai, China
A Isotretinoin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Isotretinoin, including repackagers and relabelers. The FDA regulates Isotretinoin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Isotretinoin 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 Isotretinoin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Isotretinoin supplier is an individual or a company that provides Isotretinoin active pharmaceutical ingredient (API) or Isotretinoin finished formulations upon request. The Isotretinoin suppliers may include Isotretinoin API manufacturers, exporters, distributors and traders.
click here to find a list of Isotretinoin 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 Isotretinoin Drug Master File in Korea (Isotretinoin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Isotretinoin. The MFDS reviews the Isotretinoin KDMF as part of the drug registration process and uses the information provided in the Isotretinoin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Isotretinoin 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 Isotretinoin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Isotretinoin suppliers with KDMF on PharmaCompass.
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