Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
01 1Farmhispania
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Veranova
04 1Dr. Reddy's Laboratories
05 1CQ INTERNATIONAL CO INC
06 1Emcure Pharmaceuticals
07 1Fresenius Kabi AB Brunna
08 1Hansoh Pharma
09 1ITF CHEMICAL LTDA
10 1Intas Pharmaceuticals
11 1Lunan Pharmaceutical
12 1MSN Laboratories
13 1Qilu Pharmaceutical
14 1Reliance Life Sciences Private Limited
15 2ScinoPharm Taiwan, Ltd
16 1Shilpa Medicare
17 1Sun Pharmaceutical Industries Limited
18 1Wuhan Calmland Pharmaceuticals
19 1Zhejiang Hisun Pharmaceutical
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34163
Submission : 2019-10-08
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-04
Pay. Date : 2016-01-06
DMF Number : 29697
Submission : 2015-09-30
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25218
Submission : 2011-08-18
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23596
Submission : 2010-03-03
Status :
Type : II
A Decitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Decitabine, including repackagers and relabelers. The FDA regulates Decitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Decitabine 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 Decitabine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Decitabine supplier is an individual or a company that provides Decitabine active pharmaceutical ingredient (API) or Decitabine finished formulations upon request. The Decitabine suppliers may include Decitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Decitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Decitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Decitabine active pharmaceutical ingredient (API) in detail. Different forms of Decitabine DMFs exist exist since differing nations have different regulations, such as Decitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Decitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Decitabine USDMF includes data on Decitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Decitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Decitabine suppliers with USDMF on PharmaCompass.
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