Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 2Alembic Pharmaceuticals Limited
03 1Alkaloida Chemical Company Zrt
04 1Aurobindo Pharma Limited
05 1Cilag AG
06 1Cipla
07 2Dishman Carbogen Amcis
08 1Divis Laboratories
09 1Glenmark Life Sciences
10 1Global Calcium
11 1Hetero Drugs
12 1Johnson & Johnson Innovative Medicine
13 1Lupin Ltd
14 1MSN Laboratories
15 1ScinoPharm Taiwan, Ltd
16 1Signa S.A. de C.V.
17 1Sun Pharmaceutical Industries Limited
18 1Torrent Pharmaceuticals Limited
19 1Unichem Laboratories Limited
20 2Unimark Remedies Limited
21 1Zhejiang Huahai Pharmaceutical
22 1Zydus Lifesciences
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-03
Pay. Date : 2013-05-21
DMF Number : 20581
Submission : 2007-06-06
Status :
Type : II
A Topiramate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Topiramate, including repackagers and relabelers. The FDA regulates Topiramate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Topiramate 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 Topiramate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Topiramate supplier is an individual or a company that provides Topiramate active pharmaceutical ingredient (API) or Topiramate finished formulations upon request. The Topiramate suppliers may include Topiramate API manufacturers, exporters, distributors and traders.
click here to find a list of Topiramate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Topiramate DMF (Drug Master File) is a document detailing the whole manufacturing process of Topiramate active pharmaceutical ingredient (API) in detail. Different forms of Topiramate DMFs exist exist since differing nations have different regulations, such as Topiramate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Topiramate DMF submitted to regulatory agencies in the US is known as a USDMF. Topiramate USDMF includes data on Topiramate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Topiramate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Topiramate suppliers with USDMF on PharmaCompass.
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