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 Apolar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apolar, including repackagers and relabelers. The FDA regulates Apolar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apolar 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 Apolar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Apolar supplier is an individual or a company that provides Apolar active pharmaceutical ingredient (API) or Apolar finished formulations upon request. The Apolar suppliers may include Apolar API manufacturers, exporters, distributors and traders.
click here to find a list of Apolar 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 Apolar Drug Master File in Korea (Apolar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Apolar. The MFDS reviews the Apolar KDMF as part of the drug registration process and uses the information provided in the Apolar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Apolar 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 Apolar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Apolar suppliers with KDMF on PharmaCompass.
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