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List of all Manufacturers, Suppliers & Exporters of Temozolamide API listed on PharmaCompass with details of regulatory filings

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 ChemWerth Inc (1)

03 Suanfarma (1)

04 Fareva (1)

05 Seqens (1)

06 LGM Pharma (1)

07 Tofigh Daru (1)

08 American Pacific Corporation (1)

09 Aspire Lifesciences Pvt Ltd (1)

10 Beijing Fukangren Biopharmaceutical (1)

11 Beijing Lunarsun Pharmaceutical Co., Ltd (1)

12 Beijing Mesochem Technology (1)

13 Berr Chemical Company Ltd (1)

14 ChemGenix Laboratories Pvt Ltd (1)

15 Cipla (1)

16 Formosa Laboratories (1)

17 Fujian South Pharmaceutical (1)

18 GLOPEC INTERNATIONAL INC (1)

19 Guangzhou Tosun Pharmaceutical (1)

20 Hetero Drugs (1)

21 Hoventa Pharma (2)

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

23 ITF CHEMICAL LTDA (1)

24 Ind Swift Laboratories Limited (1)

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

26 Jiwan Pharmaceutical Technology Co., Ltd (1)

27 Kekule Pharma (1)

28 Laurus Labs (1)

29 Mac-Chem Products (India) Pvt.Ltd (1)

30 NEWEDGE Overseas (1)

31 Reliance Life Sciences Private Limited (1)

32 Sakar Healthcare (1)

33 Shilpa Medicare (1)

34 Shivalik Rasayan (1)

35 Sionc Pharmaceuticals (1)

36 Stason Pharmaceuticals, Inc. (1)

37 Sun Pharmaceutical Industries Limited (1)

38 Suzhou Lixin Pharmaceutical (1)

39 Synthland (1)

40 Tecoland Corporation (1)

41 Vannsh Life Sciences (1)

42 Zyphars Biopharmaceuticals (1)

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01 Brazil (1)

02 Canada (1)

03 China (11)

04 France (1)

05 India (20)

06 Iran (1)

07 Luxembourg (1)

08 Spain (1)

09 Taiwan (1)

10 U.S.A (5)

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01 Active (15)

02 Inactive (1)

03 Blank (27)

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01 Valid (7)

02 Blank (36)

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01 228MF10125 (1)

02 228MF10143 (1)

03 302MF10046 (1)

04 Blank (40)

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01 WC-0003 (1)

02 WC-0041 (1)

03 WC-0138 (1)

04 WC-0148 (1)

05 WC-0159 (1)

06 WC-0198 (1)

07 WC-0213 (1)

08 WC-0273 (1)

09 Blank (35)

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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
R0-CEP 2019-053 - Rev 00
Status
Valid
 
Filing Details
Temozolomide
Issue/Submission Date
2021-02-16
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
23547
Status
Active
Fees Paid
N/A
 
Filing Details
TEMOZOLOMIDE (NON-STERILE BULK DRUG...
Issue/Submission Date
2010-02-17
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26032
302MF10046
Status
Active
Fees Paid
Reviewed
 
Filing Details
TEMOZOLOMIDE
Temozolomide at NUERNBERGER STRASSE...
Issue/Submission Date
2012-08-16
2020-04-17
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
19347
CEP 2020-426 - Rev 01
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
TEMOZOLOMIDE
Temozolomide
Issue/Submission Date
2006-04-10
2023-09-14
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
27715
Status
Active
Fees Paid
N/A
 
Filing Details
TEMOZOLOMIDE
Issue/Submission Date
2013-10-22
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26534
Status
Active
Fees Paid
Reviewed
 
Filing Details
TEMOZOLOMIDE, USP
Issue/Submission Date
2012-10-10
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USDMF

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CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Caution WC

Application Number
23479
R1-CEP 2016-277 - Rev 00
228MF10125
Indian CDSCO WC-0148
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-02
Filing Details
TEMOZOLOMIDE USP
Temozolomide
Temozolomide at Shilpa House, #12-6...
Temozolomide (IH)
Issue/Submission Date
2010-01-22
2022-07-12
2016-07-12
2019-07-05
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
23158
R0-CEP 2017-245 - Rev 00
228MF10143
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
TEMOZOLOMIDE
Temozolomide
Temozolomide at 36 Hoping Street, L...
Issue/Submission Date
2009-10-06
2019-06-04
2016-08-03
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
28580
Status
Active
Fees Paid
Reviewed
 
Filing Details
TEMOZOLOMIDE
Issue/Submission Date
2014-09-25
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
25344
CEP 2017-270 - Rev 01
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
TEMOZOLOMIDE, USP
Temozolomide, FORM-III
Temozolomide (USP/IH)
Issue/Submission Date
2011-10-03
2024-01-16
2022-09-16
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
22775
Indian CDSCO WC-0198
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-21
Filing Details
TEMOZOLOMIDE USP
Temozolomide (USP/EP)
Issue/Submission Date
2009-05-12
2022-08-31
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
23553
Indian CDSCO WC-0159
Status
Active
Fees Paid
N/A
 
Valid
2025-07-25
Filing Details
TEMOZOLOMIDE USP
Temozolomide (USP)
Issue/Submission Date
2010-03-08
2022-06-08
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
24173
Status
Active
Fees Unpaid
N/A
 
Filing Details
TEMOZOLOMIDE
Issue/Submission Date
2010-08-06
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USDMF

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Application Number
24352
Status
Active
Fees Unpaid
N/A
 
Filing Details
TEMOZOLOMIDE
Issue/Submission Date
2010-11-09
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USDMF

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Japanese DMF

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Application Number
21669
Status
Active
Fees Unpaid
N/A
 
Filing Details
TEMOZOLOMIDE (BULK, NON-STERILE ACT...
Issue/Submission Date
2008-05-25
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
24298
Indian CDSCO WC-0003
Status
Active
Fees Paid
Reviewed
 
Valid
2025-05-27
Filing Details
TEMOZOLOMIDE USP
Temozolomide (USP)
Issue/Submission Date
2010-12-17
2022-06-03
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USDMF

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CEP/COS

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Application Number
29028
Indian CDSCO WC-0138
Status
Inactive
Fees Paid
N/A
 
Expired
2022-08-08
Filing Details
TEMOZOLOMIDE USP
Temozolomide (USP)/IH
Issue/Submission Date
2015-01-30
2019-08-09
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USDMF

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Issue/Submission Date
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USDMF

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CEP/COS

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Written Confirmation

Caution WC

Application Number
Indian CDSCO WC-0273
Status
 
Expired
2023-05-11
Filing Details
Temozolomid IH
Issue/Submission Date
2020-07-23
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USDMF

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USDMF

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USDMF

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Japanese DMF

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Application Number
R0-CEP 2020-359 - Rev 00
Status
Valid
 
Filing Details
Temozolomide
Issue/Submission Date
2022-04-26
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USDMF

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CEP/COS

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Application Number
Indian CDSCO WC-0213
Status
 
Valid
2025-07-02
Filing Details
Temozolamide
Issue/Submission Date
2023-07-03
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
CEP 2021-394 - Rev 00
Status
Valid
 
Filing Details
Temozolomide
Issue/Submission Date
2023-11-07
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Looking for 85622-93-1 / Temozolomide API manufacturers, exporters & distributors?

Temozolomide manufacturers, exporters & distributors 1

90

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.

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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