01 1Hetero Labs Limited
02 1SUN PHARMACEUTICAL INDUSTRIES LIMITED.
01 1Cilazapril
02 1Cilazapril hydrate [CP]
01 2India
Registration Number : 226MF10204
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Andhra Prad...
Initial Date of Registration : 2014-10-27
Latest Date of Registration : 2014-10-27
Registration Number : 219MF10214
Registrant's Address : SUN HOUSE, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Ma...
Initial Date of Registration : 2007-06-25
Latest Date of Registration : 2007-06-25
A Cilazapril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cilazapril, including repackagers and relabelers. The FDA regulates Cilazapril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cilazapril 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 Cilazapril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cilazapril supplier is an individual or a company that provides Cilazapril active pharmaceutical ingredient (API) or Cilazapril finished formulations upon request. The Cilazapril suppliers may include Cilazapril API manufacturers, exporters, distributors and traders.
click here to find a list of Cilazapril 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 Cilazapril Drug Master File in Japan (Cilazapril JDMF) empowers Cilazapril 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 Cilazapril JDMF during the approval evaluation for pharmaceutical products. At the time of Cilazapril 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 Cilazapril suppliers with JDMF on PharmaCompass.
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