01 1Syn-Tech Chem. & Pharm. Co. , Ltd.
01 1Epinephrine Hydrogentrate
01 1Taiwan
Registration Number : 303MF10034
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2021-02-16
Latest Date of Registration : 2021-02-16
A (-)-Epinephrine (+)-bitartrate salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (-)-Epinephrine (+)-bitartrate salt, including repackagers and relabelers. The FDA regulates (-)-Epinephrine (+)-bitartrate salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (-)-Epinephrine (+)-bitartrate salt 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 (-)-Epinephrine (+)-bitartrate salt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (-)-Epinephrine (+)-bitartrate salt supplier is an individual or a company that provides (-)-Epinephrine (+)-bitartrate salt active pharmaceutical ingredient (API) or (-)-Epinephrine (+)-bitartrate salt finished formulations upon request. The (-)-Epinephrine (+)-bitartrate salt suppliers may include (-)-Epinephrine (+)-bitartrate salt API manufacturers, exporters, distributors and traders.
click here to find a list of (-)-Epinephrine (+)-bitartrate salt 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 (-)-Epinephrine (+)-bitartrate salt Drug Master File in Japan ((-)-Epinephrine (+)-bitartrate salt JDMF) empowers (-)-Epinephrine (+)-bitartrate salt 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 (-)-Epinephrine (+)-bitartrate salt JDMF during the approval evaluation for pharmaceutical products. At the time of (-)-Epinephrine (+)-bitartrate salt 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 (-)-Epinephrine (+)-bitartrate salt suppliers with JDMF on PharmaCompass.
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