Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2021-11-30
Registration Number : 20210309-211-J-857(3)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Insung Trading Co., Ltd.
Registration Date : 2021-03-09
Registration Number : 20210309-211-J-857
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2021-07-05
Registration Number : 20210309-211-J-857(2)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist – 500055, T...
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2021-06-04
Registration Number : 20210309-211-J-857(1)
Manufacturer Name : Granules India Limited
Manufacturer Address : 15A/1, IDA, Phase-III, Jeedimetla, Quthbullapur Mandal, Malkajgiri Dist-500 055.,Tela...
A Oresol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oresol, including repackagers and relabelers. The FDA regulates Oresol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oresol 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 Oresol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oresol supplier is an individual or a company that provides Oresol active pharmaceutical ingredient (API) or Oresol finished formulations upon request. The Oresol suppliers may include Oresol API manufacturers, exporters, distributors and traders.
click here to find a list of Oresol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price 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 Oresol Drug Master File in Korea (Oresol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oresol. The MFDS reviews the Oresol KDMF as part of the drug registration process and uses the information provided in the Oresol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oresol 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 Oresol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oresol suppliers with KDMF on PharmaCompass.
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