Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Polpharma
02 2TAPI Technology & API Services
03 1American Chemical Products
04 1Amoli Organics
05 1CTX Lifesciences
06 1Corden Pharma Bergamo S.p.A
07 1DMFs Not Supported
08 1Dasami Lab
09 1F.I.S. Fabbrica Italiana Sintetici
10 1Jubilant Generics
11 1RP SCHERER GMBH & CO. KG
12 1Recordati
13 1SAFC
14 2Siegfried AG
15 1Taro Pharmaceutical Industries
16 2Zhejiang Jiuzhou Pharmaceutical
17 3Blank
01 8CARBAMAZEPINE
02 1CARBAMAZEPINE (CARBATOL)
03 1CARBAMAZEPINE BULK DRUG SUBSTANCE
04 1CARBAMAZEPINE PROCESS B
05 8CARBAMAZEPINE USP
06 1CARBAMAZEPINE-13C1, 15N1 FOR CLINICAL RESEARCH
07 1DIETHYL CARBAMAZINE
08 1TEGRETOL S.R. CAPSULES
01 2China
02 1Germany
03 4India
04 2Israel
05 3Italy
06 1Poland
07 2Switzerland
08 3U.S.A
09 4Blank
01 11Active
02 11Inactive
01 7Complete
02 15Blank
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-16
Pay. Date : 2015-06-25
DMF Number : 26266
Submission : 2012-07-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 4719
Submission : 1982-11-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13125
Submission : 1998-08-11
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-27
Pay. Date : 2013-01-15
DMF Number : 23170
Submission : 2009-10-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 24195
Submission : 2010-09-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6641
Submission : 1986-10-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-01
Pay. Date : 2014-07-25
DMF Number : 14410
Submission : 1999-09-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4341
Submission : 1981-11-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15195
Submission : 2000-12-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4929
Submission : 1983-03-17
Status : Active
Type : II
A Carbamazepine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbamazepine, including repackagers and relabelers. The FDA regulates Carbamazepine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbamazepine 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 Carbamazepine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carbamazepine supplier is an individual or a company that provides Carbamazepine active pharmaceutical ingredient (API) or Carbamazepine finished formulations upon request. The Carbamazepine suppliers may include Carbamazepine API manufacturers, exporters, distributors and traders.
click here to find a list of Carbamazepine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbamazepine DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbamazepine active pharmaceutical ingredient (API) in detail. Different forms of Carbamazepine DMFs exist exist since differing nations have different regulations, such as Carbamazepine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbamazepine DMF submitted to regulatory agencies in the US is known as a USDMF. Carbamazepine USDMF includes data on Carbamazepine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbamazepine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbamazepine suppliers with USDMF on PharmaCompass.
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