01 1RL Fine Chem Pvt Ltd
01 1Samoh Pharmaceutical Co., Ltd.
01 1Orphenadrine citrate
01 1India
Registrant Name : Samoh 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...
A Orphenadrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Orphenadrine, including repackagers and relabelers. The FDA regulates Orphenadrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Orphenadrine 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 Orphenadrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Orphenadrine supplier is an individual or a company that provides Orphenadrine active pharmaceutical ingredient (API) or Orphenadrine finished formulations upon request. The Orphenadrine suppliers may include Orphenadrine API manufacturers, exporters, distributors and traders.
click here to find a list of Orphenadrine 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 Orphenadrine Drug Master File in Korea (Orphenadrine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Orphenadrine. The MFDS reviews the Orphenadrine KDMF as part of the drug registration process and uses the information provided in the Orphenadrine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Orphenadrine 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 Orphenadrine API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Orphenadrine suppliers with KDMF on PharmaCompass.
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