01 1HETERO DRUGS LIMITED.
01 1Ritonavir
01 1India
Registration Number : 306MF10153
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2024-11-27
Latest Date of Registration : 2024-11-27
A Ritonavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ritonavir, including repackagers and relabelers. The FDA regulates Ritonavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ritonavir 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 Ritonavir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ritonavir supplier is an individual or a company that provides Ritonavir active pharmaceutical ingredient (API) or Ritonavir finished formulations upon request. The Ritonavir suppliers may include Ritonavir API manufacturers, exporters, distributors and traders.
click here to find a list of Ritonavir 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 Ritonavir Drug Master File in Japan (Ritonavir JDMF) empowers Ritonavir 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 Ritonavir JDMF during the approval evaluation for pharmaceutical products. At the time of Ritonavir 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 Ritonavir suppliers with JDMF on PharmaCompass.
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