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
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A Adrenalini tartras manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Adrenalini tartras, including repackagers and relabelers. The FDA regulates Adrenalini tartras manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Adrenalini tartras API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Adrenalini tartras supplier is an individual or a company that provides Adrenalini tartras active pharmaceutical ingredient (API) or Adrenalini tartras finished formulations upon request. The Adrenalini tartras suppliers may include Adrenalini tartras API manufacturers, exporters, distributors and traders.
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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 Adrenalini tartras Drug Master File in Japan (Adrenalini tartras JDMF) empowers Adrenalini tartras 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 Adrenalini tartras JDMF during the approval evaluation for pharmaceutical products. At the time of Adrenalini tartras JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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