Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
01 1EGIS PHARMACEUTICALS PRIVATE LIMITED COMPANY
02 1Dandong Yichuang Pharmaceutical Co. ,Ltd
01 1Promethazine Hydrochloride
02 1Promethazine hydrochloride
01 1China
02 1Hungary
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Registration Number : 307MF10033
Registrant's Address : H-1106 BUDAPEST KERESZTURI UT 30-38 HUNGARY
Initial Date of Registration : 2025-02-07
Latest Date of Registration : 2025-02-07
Registration Number : 218MF10771
Registrant's Address : No. 64 Xingqi Road, Zhexing District, Dandong, Liaoning, China
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2009-06-30
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A PROMETHAZINE WITH CODEINE-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of PROMETHAZINE WITH CODEINE-1, including repackagers and relabelers. The FDA regulates PROMETHAZINE WITH CODEINE-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. PROMETHAZINE WITH CODEINE-1 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 PROMETHAZINE WITH CODEINE-1 supplier is an individual or a company that provides PROMETHAZINE WITH CODEINE-1 active pharmaceutical ingredient (API) or PROMETHAZINE WITH CODEINE-1 finished formulations upon request. The PROMETHAZINE WITH CODEINE-1 suppliers may include PROMETHAZINE WITH CODEINE-1 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 PROMETHAZINE WITH CODEINE-1 Drug Master File in Japan (PROMETHAZINE WITH CODEINE-1 JDMF) empowers PROMETHAZINE WITH CODEINE-1 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 PROMETHAZINE WITH CODEINE-1 JDMF during the approval evaluation for pharmaceutical products. At the time of PROMETHAZINE WITH CODEINE-1 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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