Veranova: A CDMO that manages complexity with confidence.
01 1Veranova
02 1Cohance Lifesciences
03 1Granules India Limited
04 1Alembic Pharmaceuticals Limited
05 1Amoli Organics
06 1Aurobindo Pharma Limited
07 1CHEMO IBERICA SA
08 1Cipla
09 1Dipharma
10 1Glenmark Life Sciences
11 1HONOUR LAB LTD
12 1Jubilant Generics
13 1Laurus Labs
14 1Lupin Ltd
15 1MSN Laboratories
16 1Macleods Pharmaceuticals Limited
17 1Micro Labs Limited
18 1Optimus Pharma
19 1Procos
20 1Raks Pharma
21 1SIMS Srl
22 1SMS Pharmaceuticals
23 1Shilpa Medicare
24 1Signa S.A. de C.V.
25 1Viatris
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-27
Pay. Date : 2018-03-30
DMF Number : 32680
Submission : 2018-03-30
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-20
Pay. Date : 2018-03-01
DMF Number : 32201
Submission : 2017-10-28
Status :
Type : II
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-19
Pay. Date : 2018-08-03
DMF Number : 30922
Submission : 2016-09-30
Status :
Type : II
A Pirfenidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pirfenidone, including repackagers and relabelers. The FDA regulates Pirfenidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pirfenidone 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 Pirfenidone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pirfenidone supplier is an individual or a company that provides Pirfenidone active pharmaceutical ingredient (API) or Pirfenidone finished formulations upon request. The Pirfenidone suppliers may include Pirfenidone API manufacturers, exporters, distributors and traders.
click here to find a list of Pirfenidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pirfenidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Pirfenidone active pharmaceutical ingredient (API) in detail. Different forms of Pirfenidone DMFs exist exist since differing nations have different regulations, such as Pirfenidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pirfenidone DMF submitted to regulatory agencies in the US is known as a USDMF. Pirfenidone USDMF includes data on Pirfenidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pirfenidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pirfenidone suppliers with USDMF on PharmaCompass.
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