01 1CSPC Innovation Pharmaceutical Co., Ltd.
02 1Shanghai Ethypharm Pharmaceuticals Co., Ltd.@CSPC Innovation Pharmaceutical Co., Ltd.
01 2Alvogen Korea Co., Ltd.
01 2Theophylline
01 2China
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2025-02-14
Registration Number : 20250214-209-J-1767
Manufacturer Name : CSPC Innovation Pharmaceutic...
Manufacturer Address : No.62 Zhangju Road, Luancheng County, Shijiazhuang City, Hebei Province, China
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2025-02-14
Registration Number : 20250214-209-J-1768
Manufacturer Name : Shanghai Ethypharm Pharmaceu...
Manufacturer Address : No.278, Qianyun Road, South of No.16 Bridge, State Road 318, Xujing, Qingpu District,...
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PharmaCompass offers a list of Theophylline API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Theophylline manufacturer or Theophylline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Theophylline manufacturer or Theophylline supplier.
A Hylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hylate, including repackagers and relabelers. The FDA regulates Hylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hylate 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 Hylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Hylate supplier is an individual or a company that provides Hylate active pharmaceutical ingredient (API) or Hylate finished formulations upon request. The Hylate suppliers may include Hylate API manufacturers, exporters, distributors and traders.
click here to find a list of Hylate 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 Hylate Drug Master File in Korea (Hylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Hylate. The MFDS reviews the Hylate KDMF as part of the drug registration process and uses the information provided in the Hylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Hylate 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 Hylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Hylate suppliers with KDMF on PharmaCompass.
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