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List of Drug Master Files (DMF) of Temozolamide Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ChemWerth Inc (1)

02 Fareva (1)

03 Seqens (1)

04 American Pacific Corporation (1)

05 Beijing Lunarsun Pharmaceutical Co., Ltd (1)

06 Cipla (1)

07 Formosa Laboratories (1)

08 GLOPEC INTERNATIONAL INC (1)

09 Hetero Drugs (1)

10 Hubei Haosun Pharmaceutical Co., Ltd. (1)

11 ITF CHEMICAL LTDA (1)

12 Ind Swift Laboratories Limited (1)

13 Jiangsu Tasly Diyi Pharmaceutical Co., Ltd. CN 223 002 Huai'an (1)

14 Reliance Life Sciences Private Limited (1)

15 Shilpa Medicare (1)

16 Sun Pharmaceutical Industries Limited (1)

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01 TEMOZOLOMIDE (7)

02 TEMOZOLOMIDE (BULK, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT) (1)

03 TEMOZOLOMIDE (NON-STERILE BULK DRUG SUBSTANCE) (1)

04 TEMOZOLOMIDE USP (5)

05 TEMOZOLOMIDE, USP (2)

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01 Brazil (1)

02 Canada (1)

03 China (3)

04 France (1)

05 India (6)

06 Luxembourg (1)

07 Taiwan (1)

08 U.S.A (2)

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01 Active (15)

02 Inactive (1)

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01 Complete (8)

02 Blank (8)

URL Supplier Web Content
23158
Active
2009-10-06
Complete
2013-07-25
2012-12-03
II
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URL Supplier Web Content
24173
Active
2010-08-06
N/A
II
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URL Supplier Web Content
24298
Active
2010-12-17
Complete
2014-02-04
2013-11-25
II
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URL Supplier Web Content
21669
Active
2008-05-25
N/A
II
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URL Supplier Web Content
22775
Active
2009-05-12
Complete
2013-10-09
2013-05-29
II
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URL Supplier Web Content
23479
Active
2010-01-22
Complete
2013-09-10
2013-09-03
II
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URL Supplier Web Content
23553
Active
2010-03-08
N/A
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Looking for 85622-93-1 / Temozolomide API manufacturers, exporters & distributors?

Temozolomide manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Temozolomide API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Temozolomide manufacturer or Temozolomide supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Temozolomide manufacturer or Temozolomide supplier.

PharmaCompass also assists you with knowing the Temozolomide API Price utilized in the formulation of products. Temozolomide API Price is not always fixed or binding as the Temozolomide Price is obtained through a variety of data sources. The Temozolomide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Temozolomide

Synonyms

85622-93-1, Methazolastone, Temodar, Temodal, Temozolamide, 3-methyl-4-oxo-3,4-dihydroimidazo[5,1-d][1,2,3,5]tetrazine-8-carboxamide

Cas Number

85622-93-1

Unique Ingredient Identifier (UNII)

YF1K15M17Y

About Temozolomide

A dacarbazine derivative that is used as an alkylating antineoplastic agent for the treatment of MALIGNANT GLIOMA and MALIGNANT MELANOMA.

Temozolamide Manufacturers

A Temozolamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Temozolamide, including repackagers and relabelers. The FDA regulates Temozolamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Temozolamide 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 Temozolamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Temozolamide Suppliers

A Temozolamide supplier is an individual or a company that provides Temozolamide active pharmaceutical ingredient (API) or Temozolamide finished formulations upon request. The Temozolamide suppliers may include Temozolamide API manufacturers, exporters, distributors and traders.

click here to find a list of Temozolamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Temozolamide USDMF

A Temozolamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Temozolamide active pharmaceutical ingredient (API) in detail. Different forms of Temozolamide DMFs exist exist since differing nations have different regulations, such as Temozolamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Temozolamide DMF submitted to regulatory agencies in the US is known as a USDMF. Temozolamide USDMF includes data on Temozolamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Temozolamide USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Temozolamide suppliers with USDMF on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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