Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 1Ami Lifesciences Private Limited
03 1Amoli Organics
04 1Archimica
05 1Aurore Life Sciences
06 2CTX Lifesciences
07 1Corden Pharma Bergamo S.p.A
08 2Dasami Lab
09 1ERREDUE S.P.A. IT 24040 Isso
10 2F.I.S. Fabbrica Italiana Sintetici
11 1Glenmark Life Sciences
12 1Hubei Gedian Humanwell Pharmaceutical
13 2Jubilant Generics
14 1Konduskar Laboratories
15 1MATRIX LABORATORIES XIAMEN LTD.
16 1MSN Laboratories
17 1Micro Labs Limited
18 1Siegfried AG
19 1Signa S.A. de C.V.
20 1Sun Pharmaceutical Industries Limited
21 1Taro Pharmaceutical Industries
22 1Trifarma
23 2Zhejiang Jiuzhou Pharmaceutical
01 1OXCARBAZEPHIN USP
02 14OXCARBAZEPINE
03 1OXCARBAZEPINE CO-PRECIPITATE
04 1OXCARBAZEPINE MICRONIZED
05 10OXCARBAZEPINE USP
06 1OXCARBAZEPINE USP (PROCESS-II)
01 4China
02 14India
03 6Italy
04 1Mexico
05 1Poland
06 1Switzerland
07 1U.S.A
01 19Active
02 9Inactive
01 15Complete
02 13Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2020-08-04
Pay. Date : 2020-02-03
DMF Number : 34418
Submission : 2019-12-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38017
Submission : 2023-03-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2017-10-16
DMF Number : 23191
Submission : 2009-10-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-26
Pay. Date : 2013-02-06
DMF Number : 16588
Submission : 2003-05-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-11-21
Pay. Date : 2013-09-20
DMF Number : 16597
Submission : 2003-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20938
Submission : 2007-10-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-19
DMF Number : 16430
Submission : 2003-03-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-02-28
Pay. Date : 2017-09-28
DMF Number : 17988
Submission : 2005-01-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-15
Pay. Date : 2014-01-02
DMF Number : 18504
Submission : 2005-07-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16339
Submission : 2002-12-26
Status : Active
Type : II
A Oxcarbazepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxcarbazepine, including repackagers and relabelers. The FDA regulates Oxcarbazepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxcarbazepine 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 Oxcarbazepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxcarbazepine supplier is an individual or a company that provides Oxcarbazepine active pharmaceutical ingredient (API) or Oxcarbazepine finished formulations upon request. The Oxcarbazepine suppliers may include Oxcarbazepine API manufacturers, exporters, distributors and traders.
click here to find a list of Oxcarbazepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxcarbazepine DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxcarbazepine active pharmaceutical ingredient (API) in detail. Different forms of Oxcarbazepine DMFs exist exist since differing nations have different regulations, such as Oxcarbazepine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxcarbazepine DMF submitted to regulatory agencies in the US is known as a USDMF. Oxcarbazepine USDMF includes data on Oxcarbazepine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxcarbazepine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxcarbazepine suppliers with USDMF on PharmaCompass.
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