01 1Henan Lihua Pharmaceutical Co.,Ltd.
01 1Otran Korea Co., Ltd.
01 1Undifferentiated desonide
01 1China
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2026-03-12
Registration Number : 20260312-209-J-2144
Manufacturer Name : Henan Lihua Pharmaceutical C...
Manufacturer Address : Qilidian, North part of Antang Road, Longan District, Anyang 455000, China
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A Zotinar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zotinar, including repackagers and relabelers. The FDA regulates Zotinar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zotinar 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 Zotinar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Zotinar supplier is an individual or a company that provides Zotinar active pharmaceutical ingredient (API) or Zotinar finished formulations upon request. The Zotinar suppliers may include Zotinar API manufacturers, exporters, distributors and traders.
click here to find a list of Zotinar 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 Zotinar Drug Master File in Korea (Zotinar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Zotinar. The MFDS reviews the Zotinar KDMF as part of the drug registration process and uses the information provided in the Zotinar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Zotinar 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 Zotinar API can apply through the Korea Drug Master File (KDMF).
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