01 1Jiangsu Hi-Stone Pharmaceutical Co. , Ltd.
02 1Quimica Syntetica S. A.
01 2Ranitidine hydrochloride
01 1China
02 1Spain
Registration Number : 218MF10877
Registrant's Address : Yaozhen Village, Zhitang Town, Changshu City, Jiangsu Province, China
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2006-11-10
Registration Number : 226MF10189
Registrant's Address : Calle Dulcinea, s/n 28805 Alcala De Henares Madrid Spain
Initial Date of Registration : 2014-09-30
Latest Date of Registration : 2014-09-30
A Zantac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zantac, including repackagers and relabelers. The FDA regulates Zantac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zantac 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 Zantac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Zantac supplier is an individual or a company that provides Zantac active pharmaceutical ingredient (API) or Zantac finished formulations upon request. The Zantac suppliers may include Zantac API manufacturers, exporters, distributors and traders.
click here to find a list of Zantac 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 Zantac Drug Master File in Japan (Zantac JDMF) empowers Zantac 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 Zantac JDMF during the approval evaluation for pharmaceutical products. At the time of Zantac 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 Zantac suppliers with JDMF on PharmaCompass.
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