01 1RL Fine Chem Pvt Ltd
01 1Sam-O Pharmaceutical Co., Ltd.
01 1Orphenadrine citrate
01 1India
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2020-10-13
Registration Number : 20201013-209-J-733
Manufacturer Name : RL Fine Chem Pvt Ltd
Manufacturer Address : Plot No. IP-27-29, KIADB Industrial Area, 1st Phase, Kudumalakunte Village, Gowribida...
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A Disipal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Disipal, including repackagers and relabelers. The FDA regulates Disipal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Disipal 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 Disipal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Disipal supplier is an individual or a company that provides Disipal active pharmaceutical ingredient (API) or Disipal finished formulations upon request. The Disipal suppliers may include Disipal API manufacturers, exporters, distributors and traders.
click here to find a list of Disipal 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 Disipal Drug Master File in Korea (Disipal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Disipal. The MFDS reviews the Disipal KDMF as part of the drug registration process and uses the information provided in the Disipal KDMF to evaluate the safety and efficacy of the drug.
After submitting a Disipal 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 Disipal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Disipal suppliers with KDMF on PharmaCompass.
