DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories Ltd.
02 1Farmhispania S. A.
03 1Fresenius Kabi Oncology Ltd.
04 1Hetero Labs Limited
05 1Jiangsu Chiatai Qingjiang Pharmaceutical Co. , Ltd.
06 1Jiangsu Hansoh Pharmaceutical Group Co. , Ltd.
07 1LAURUS LABS LIMITED.
08 1LAURUS LABS PRIVATE LIMITED.
09 1SHILPA MEDICARE LIMITED.
10 1SUN PHARMACEUTICAL INDUSTRIES LIMITED.
11 1ScinoPharm Taiwan, Ltd.
12 1Shandong Anhong Pharmaceutical Co. , Ltd.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Registration Number : 220MF10243
Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA
Initial Date of Registration : 2008-12-04
Latest Date of Registration : 2024-08-22
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Registration Number : 220MF10259
Registrant's Address : Balmes 85, Atico, 08008 (Barcelona), Spain
Initial Date of Registration : 2008-12-22
Latest Date of Registration : 2014-01-08
A Gemcitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemcitabine, including repackagers and relabelers. The FDA regulates Gemcitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemcitabine 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 Gemcitabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemcitabine supplier is an individual or a company that provides Gemcitabine active pharmaceutical ingredient (API) or Gemcitabine finished formulations upon request. The Gemcitabine suppliers may include Gemcitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Gemcitabine 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 Gemcitabine Drug Master File in Japan (Gemcitabine JDMF) empowers Gemcitabine 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 Gemcitabine JDMF during the approval evaluation for pharmaceutical products. At the time of Gemcitabine 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 Gemcitabine suppliers with JDMF on PharmaCompass.
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