DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories Ltd.
02 1Hetero Labs Limited
03 1Shilpa Pharma Lifesciences Limited
01 2Azacitidine
02 1Azacitidine "D"
01 3India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 302MF10075
Registrant's Address : 8-2-337, Road No. 3, Banjara Hills, Hyderabad 500 034, TELANGANA, INDIA
Initial Date of Registration : 2020-07-01
Latest Date of Registration : 2020-07-01
Registration Number : 301MF10047
Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...
Initial Date of Registration : 2019-08-20
Latest Date of Registration : 2019-08-20
Registration Number : 303MF10033
Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India
Initial Date of Registration : 2021-02-16
Latest Date of Registration : 2021-11-02
A Vidaza manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vidaza, including repackagers and relabelers. The FDA regulates Vidaza manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vidaza 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 Vidaza manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vidaza supplier is an individual or a company that provides Vidaza active pharmaceutical ingredient (API) or Vidaza finished formulations upon request. The Vidaza suppliers may include Vidaza API manufacturers, exporters, distributors and traders.
click here to find a list of Vidaza 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 Vidaza Drug Master File in Japan (Vidaza JDMF) empowers Vidaza 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 Vidaza JDMF during the approval evaluation for pharmaceutical products. At the time of Vidaza 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 Vidaza suppliers with JDMF on PharmaCompass.
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