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01 1TEMAD CO ACTIVE PHARMACEUTICAL INGREDIENTS
02 1DIVI'S LABORATORIES LIMITED
01 1Dextromethorphan base
02 1Japanese Pharmacy Hydrofluoric Acid Dextromethorphan
01 1India
02 1Iran
Dextromethorphan Hydrobromide, Japanese Pharmacopoeia
Registration Number : 219MF10366
Registrant's Address : No. 3 Bisotown St. Fatemi Sq. Tehran,Iran
Initial Date of Registration : 2007-12-13
Latest Date of Registration : 2007-12-13
Registration Number : 220MF10194
Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber Hills, Gachibowli, Hyderabad-500 032, ...
Initial Date of Registration : 2008-08-28
Latest Date of Registration : 2022-09-08
A Dextromethorphan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dextromethorphan, including repackagers and relabelers. The FDA regulates Dextromethorphan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dextromethorphan 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 Dextromethorphan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dextromethorphan supplier is an individual or a company that provides Dextromethorphan active pharmaceutical ingredient (API) or Dextromethorphan finished formulations upon request. The Dextromethorphan suppliers may include Dextromethorphan API manufacturers, exporters, distributors and traders.
click here to find a list of Dextromethorphan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Dextromethorphan Drug Master File in Japan (Dextromethorphan JDMF) empowers Dextromethorphan API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Dextromethorphan JDMF during the approval evaluation for pharmaceutical products. At the time of Dextromethorphan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Dextromethorphan suppliers with JDMF on PharmaCompass.
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