Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Seqens
03 3Aspen API
04 1Cohance Lifesciences
05 1Erregierre SpA
06 2Fareva
07 1IBI Spa
08 1Mankind Pharma
09 2Medilux Laboratories
10 1Medtronic Plc
11 1Novartis Pharmaceuticals Corporation
12 1Piramal Pharma Solutions
13 3Resolution Chemicals Limited
14 1Sumitomo Chemical
15 1Unichem Laboratories Limited
16 1Viatris
17 1Viyash Life Sciences
18 1Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-08
Pay. Date : 2012-12-11
DMF Number : 18014
Submission : 2005-01-20
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-30
DMF Number : 7077
Submission : 1987-07-14
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6421
Submission : 1986-06-18
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 : 2018-12-29
Pay. Date : 2018-11-26
DMF Number : 33302
Submission : 2018-11-09
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35224
Submission : 2020-10-16
Status :
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12541
Submission : 1997-04-17
Status :
Type : IV
A Baclofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baclofen, including repackagers and relabelers. The FDA regulates Baclofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baclofen 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 Baclofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Baclofen supplier is an individual or a company that provides Baclofen active pharmaceutical ingredient (API) or Baclofen finished formulations upon request. The Baclofen suppliers may include Baclofen API manufacturers, exporters, distributors and traders.
click here to find a list of Baclofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Baclofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Baclofen active pharmaceutical ingredient (API) in detail. Different forms of Baclofen DMFs exist exist since differing nations have different regulations, such as Baclofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Baclofen DMF submitted to regulatory agencies in the US is known as a USDMF. Baclofen USDMF includes data on Baclofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Baclofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Baclofen suppliers with USDMF on PharmaCompass.
We have 17 companies offering Baclofen
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