ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
01 1ChemWerth Inc
02 1Seqens
03 1American Pacific Corporation
04 1Beijing Lunarsun Pharmaceutical Co., Ltd
05 1Cipla
06 1Fareva
07 1Formosa Laboratories
08 1GLOPEC INTERNATIONAL INC
09 1Hetero Drugs
10 1Hubei Haosun Pharmaceutical Co., Ltd.
11 1ITF CHEMICAL LTDA
12 1Ind Swift Laboratories Limited
13 1Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. CN 223 002 Huai'an
14 1Reliance Life Sciences Private Limited
15 1Shilpa Medicare
16 1Sun Pharmaceutical Industries Limited
01 7TEMOZOLOMIDE
02 1TEMOZOLOMIDE (BULK, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT)
03 1TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE)
04 5TEMOZOLOMIDE USP
05 2TEMOZOLOMIDE, USP
01 1Brazil
02 1Canada
03 3China
04 1France
05 6India
06 1Luxembourg
07 1Taiwan
08 2U.S.A
01 15Active
02 1Inactive
01 8Complete
02 8Blank
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23547
Submission : 2010-02-17
Status : Active
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19347
Submission : 2006-04-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24352
Submission : 2010-11-09
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-25
Pay. Date : 2012-12-03
DMF Number : 23158
Submission : 2009-10-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24173
Submission : 2010-08-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-04
Pay. Date : 2013-11-25
DMF Number : 24298
Submission : 2010-12-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21669
Submission : 2008-05-25
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-09
Pay. Date : 2013-05-29
DMF Number : 22775
Submission : 2009-05-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-09-03
DMF Number : 23479
Submission : 2010-01-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23553
Submission : 2010-03-08
Status : Active
Type : II
A Temozolomide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temozolomide, including repackagers and relabelers. The FDA regulates Temozolomide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temozolomide 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 Temozolomide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Temozolomide supplier is an individual or a company that provides Temozolomide active pharmaceutical ingredient (API) or Temozolomide finished formulations upon request. The Temozolomide suppliers may include Temozolomide API manufacturers, exporters, distributors and traders.
click here to find a list of Temozolomide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Temozolomide DMF (Drug Master File) is a document detailing the whole manufacturing process of Temozolomide active pharmaceutical ingredient (API) in detail. Different forms of Temozolomide DMFs exist exist since differing nations have different regulations, such as Temozolomide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Temozolomide DMF submitted to regulatory agencies in the US is known as a USDMF. Temozolomide USDMF includes data on Temozolomide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Temozolomide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Temozolomide suppliers with USDMF on PharmaCompass.
We have 16 companies offering Temozolomide
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