01 1Apothecon Pharmaceuticals Pvt. Limited
01 1HO Pharm Co., Ltd.
01 1Camustin
01 1India
Registrant Name : HO Pharm Co., Ltd.
Registration Date : 2021-04-26
Registration Number : 20210426-210-J-954
Manufacturer Name : Apothecon Pharmaceuticals Pv...
Manufacturer Address : PLOT NO 1134, 1135, 1136, 1137, 1143B, 1144 A&B, 1138 A&B, Padra Jambusar Highway, Ta...
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PharmaCompass offers a list of Carmustine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Carmustine manufacturer or Carmustine supplier for your needs.
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A Gliadel Wafer manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gliadel Wafer, including repackagers and relabelers. The FDA regulates Gliadel Wafer manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gliadel Wafer API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Gliadel Wafer supplier is an individual or a company that provides Gliadel Wafer active pharmaceutical ingredient (API) or Gliadel Wafer finished formulations upon request. The Gliadel Wafer suppliers may include Gliadel Wafer API manufacturers, exporters, distributors and traders.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gliadel Wafer Drug Master File in Korea (Gliadel Wafer KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gliadel Wafer. The MFDS reviews the Gliadel Wafer KDMF as part of the drug registration process and uses the information provided in the Gliadel Wafer KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gliadel Wafer 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 Gliadel Wafer API can apply through the Korea Drug Master File (KDMF).
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