01 1Syn-Tech Chem &Pharm. Co., Ltd.
01 1Wooshin Labotach Co., Ltd.
01 1Pramoxine hydrochloride
01 1Taiwan
Registrant Name : Wooshin Labotach Co., Ltd.
Registration Date : 2022-10-20
Registration Number : 20221020-211-J-1385
Manufacturer Name : Syn-Tech Chem &Pharm. Co., L...
Manufacturer Address : No. 168 Kai Yuan Rd., Hsin-Ying, Tainan City, 73055, Taiwan
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A Proctocream-HC manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Proctocream-HC, including repackagers and relabelers. The FDA regulates Proctocream-HC manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Proctocream-HC 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 Proctocream-HC manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Proctocream-HC supplier is an individual or a company that provides Proctocream-HC active pharmaceutical ingredient (API) or Proctocream-HC finished formulations upon request. The Proctocream-HC suppliers may include Proctocream-HC API manufacturers, exporters, distributors and traders.
click here to find a list of Proctocream-HC 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 Proctocream-HC Drug Master File in Korea (Proctocream-HC KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Proctocream-HC. The MFDS reviews the Proctocream-HC KDMF as part of the drug registration process and uses the information provided in the Proctocream-HC KDMF to evaluate the safety and efficacy of the drug.
After submitting a Proctocream-HC 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 Proctocream-HC API can apply through the Korea Drug Master File (KDMF).
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