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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epinephrine Bitartrate, including repackagers and relabelers. The FDA regulates Epinephrine Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epinephrine Bitartrate 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epinephrine Bitartrate supplier is an individual or a company that provides Epinephrine Bitartrate active pharmaceutical ingredient (API) or Epinephrine Bitartrate finished formulations upon request. The Epinephrine Bitartrate suppliers may include Epinephrine Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Epinephrine Bitartrate 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 Drug Master File in Japan (Epinephrine Bitartrate JDMF) empowers Epinephrine Bitartrate 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Epinephrine Bitartrate 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 suppliers with JDMF on PharmaCompass.
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