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

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01 Dr. Reddy's Laboratories (1)

02 DKSH (1)

03 LGM Pharma (1)

04 HRV Global Life Sciences (1)

05 Sigmak Lifesciences (1)

06 Arch Pharmalabs (2)

07 Archimica (1)

08 Aspen Biopharma Labs (1)

09 Beijing Fukangren Biopharmaceutical (1)

10 Beijing Lunarsun Pharmaceutical Co., Ltd (1)

11 Benzo Chem Industries Pvt. Ltd. (1)

12 Biesterfeld Spezialchemie GmbH (1)

13 Bo-Chem Pvt Ltd (1)

14 ChemGenix Laboratories Pvt Ltd (1)

15 Cipla (1)

16 Dishman Carbogen Amcis (2)

17 Eli Lilly (1)

18 Emcure Pharmaceuticals (2)

19 Farmhispania (1)

20 Fresenius Kabi AB Brunna (1)

21 Fresenius Kabi AG (1)

22 Fresenius Kabi Oncology Limited (3)

23 Fuan Pharmaceutical (1)

24 Fujian South Pharmaceutical (1)

25 GLAND CHEMICALS PRIVATE LIMITED (1)

26 Guangzhou Tosun Pharmaceutical (1)

27 Hangzhou Think Chemical Co.Ltd (1)

28 Hansoh Pharma (2)

29 Hetero Drugs (2)

30 Hoventa Pharma (2)

31 Intas Pharmaceuticals (2)

32 JARI Pharmaceutical Co., Ltd. (1)

33 Jiangsu Chiatai Qingjiang Pharmaceutical (1)

34 Jin Dun Medical (1)

35 Kekule Pharma (1)

36 Laurus Labs (2)

37 MSN Laboratories (1)

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

39 Mustafa Nevzat Ilac Sanayi A S (1)

40 NEWEDGE Overseas (1)

41 NINGBO TEAM PHARMACEUTICAL CO., LTD. CN 315 201 Ningbo (1)

42 Nishchem International Pvt. Ltd (1)

43 Olon S.p.A (1)

44 PharmaEssentia (1)

45 Plantex Ltd. (1)

46 Qilu Pharmaceutical (1)

47 Sakar Healthcare (1)

48 ScinoPharm Taiwan, Ltd (1)

49 Shandong Anhong Pharmaceutical (1)

50 Shenzhen Haorui (1)

51 Shilpa Medicare (2)

52 Sun Pharmaceutical Industries Limited (1)

53 Synthland (1)

54 Tecoland Corporation (1)

55 Teva API (2)

56 Teva Pharmaceutical Industries (2)

57 Vannsh Life Sciences (1)

58 Viatris (1)

59 Vinkem Labs Ltd (1)

60 Yangtze River Pharmaceutical Group (1)

61 Zhejiang Hisun Pharmaceutical (1)

62 Zydus Lifesciences (1)

63 Zyphars Biopharmaceuticals (1)

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01 China (19)

02 Germany (2)

03 India (39)

04 Israel (5)

05 Italy (2)

06 Spain (1)

07 Sweden (1)

08 Switzerland (1)

09 Taiwan (1)

10 Turkey (1)

11 U.S.A (4)

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01 Active (21)

02 Inactive (10)

03 Blank (45)

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01 Expired (1)

02 Valid (19)

03 Withdrawn by EDQM Failure to CEP procedure (2)

04 Withdrawn by Holder (2)

05 Blank (52)

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01 220MF10243 (1)

02 220MF10259 (1)

03 221MF10017 (1)

04 221MF10018 (1)

05 221MF10023 (1)

06 221MF10118 (1)

07 224MF10027 (1)

08 224MF10032 (1)

09 225MF10174 (1)

10 229MF10063 (1)

11 230MF10056 (1)

12 230MF10069 (1)

13 230MF10173 (1)

14 Blank (63)

filter

01 WC-0039 (1)

02 WC-0041 (1)

03 WC-0115 (1)

04 WC-0135 (1)

05 WC-0135A (1)

06 WC-0138 (1)

07 WC-0148 (1)

08 WC-0159 (1)

09 WC-0213 (1)

10 WC-0226 (1)

11 WC-0275 (1)

12 WC-0349 (1)

13 WC-0353 (1)

14 Blank (63)

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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
18857
R1-CEP 2007-075 - Rev 06
220MF10243
Indian CDSCO WC-0039
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
GEMCITABINE HYDROCHLORIDE at 8-2-33...
Gemcitabine Hydrochloride
Issue/Submission Date
2005-10-11
2021-06-18
2008-12-04
2022-06-06
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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
Status
 
Filing Details
Issue/Submission Date
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

Swiss Biotech Day

Not Confirmed

envelop Contact Supplier
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USDMF

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CEP/COS

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Japanese DMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Sigmak Lifesciences CB

Swiss Biotech Day

Not Confirmed

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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
22229
R0-CEP 2022-499 - Rev 00
230MF10173
Indian CDSCO WC-0041
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride, GA proce...
Gemcitabine hydrochloride [D] at 7-...
Gemcitabine Hydrochloride (USP/Ph. ...
Issue/Submission Date
2008-11-26
2023-02-28
2018-12-21
2022-09-16
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Caution WC

Application Number
24136
R1-CEP 2006-222 - Rev 01
221MF10017
Indian CDSCO WC-0148
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-02
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
Gemcitabine hydrochloride at 10/80,...
Gemcitabine Hydrochloride (USP/Ph. ...
Issue/Submission Date
2011-03-04
2023-02-23
2009-01-13
2019-07-05
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
31892
CEP 2017-187 - Rev 02
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP (PROC...
Gemcitabine hydrochloride, Process-...
Issue/Submission Date
2017-07-18
2024-01-04
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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
20979
Status
Active
Fees Paid
Reviewed
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2007-10-29
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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
27402
Status
Active
Fees Paid
Reviewed
 
Filing Details
GEMCITABINE HYDROCHLORIDE (A-MESYLR...
Issue/Submission Date
2014-02-20
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
23339
Indian CDSCO WC-0226
Status
Active
Fees Paid
N/A
 
Expired
2022-07-02
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine Hydrochloride (USP, Ph ...
Issue/Submission Date
2009-12-04
2019-10-07
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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
27617
Status
Active
Fees Paid
Reviewed
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP (PROC...
Issue/Submission Date
2013-10-25
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
19427
R1-CEP 2007-021 - Rev 01
221MF10018
Indian CDSCO WC-0159
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-25
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
GEMCITABINE HYDROCHLORIDE at SUN HO...
Gemcitabine Hydrochloride (USP/EP/B...
Issue/Submission Date
2006-05-16
2015-07-28
2009-01-28
2022-06-08
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
27043
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
 
Valid
2025-05-05
Filing Details
GEMCITABINE HYDROCHLORIDE USP [ROUT...
Gemcitabine Hydrochloride (USP)
Issue/Submission Date
2013-05-30
2022-09-02
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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
31117
Status
Active
Fees Unpaid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE NON-STERI...
Issue/Submission Date
2018-11-04
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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
31481
Status
Active
Fees Paid
Reviewed
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2017-03-24
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
25938
Indian CDSCO WC-0353
Status
Active
Fees Paid
Reviewed
 
Expired
2022-01-18
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine Hydrochloride USP/EP
Issue/Submission Date
2012-06-06
2019-12-05
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
24893
R0-CEP 2011-117 - Rev 01
Status
Active
Fees Paid
Reviewed
Withdrawn by Holder
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
Issue/Submission Date
2011-04-26
2015-02-05
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Close WC

Application Number
19053
R1-CEP 2006-272 - Rev 06
221MF10023
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
Gemcitabine Hydrochloride at No. 1,...
Issue/Submission Date
2005-12-19
2022-09-08
2009-01-28
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
22748
R0-CEP 2022-092 - Rev 00
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride, Process ...
Issue/Submission Date
2009-04-15
2022-07-13
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
36573
R1-CEP 2009-089 - Rev 02
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP (PROC...
Gemcitabine hydrochloride
Issue/Submission Date
2021-12-24
2022-07-13
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
22800
R1-CEP 2009-026 - Rev 02
230MF10069
Indian CDSCO WC-0213
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
Gemcitabine Hydrochloride at 2nd Fl...
Gemcitabine Hydrchloride (USP/BP/IH...
Issue/Submission Date
2009-05-16
2023-01-24
2018-06-05
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
21399
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2008-04-22
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USDMF

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CEP/COS

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Application Number
23516
Status
Inactive
Fees Paid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2010-02-12
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USDMF

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CEP/COS

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Application Number
24278
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2010-10-14
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USDMF

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CEP/COS

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Application Number
21274
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2008-01-22
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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
18810
R1-CEP 2017-076 - Rev 00
229MF10063
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP (NON-...
Gemcitabine hydrochloride
Gemcitabine Hydrochloride at 9 Dong...
Issue/Submission Date
2005-09-24
2023-02-28
2017-03-07
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USDMF

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Application Number
24341
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2010-10-29
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USDMF

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Application Number
22199
Status
Inactive
Fees Paid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2008-10-23
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USDMF

Caution USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
27649
Indian CDSCO WC-0135A
Status
Inactive
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
GEMCITABINE HYDROCHLORIDE
Gemcitabine Hydrochloride BP/USP/EP
Issue/Submission Date
2013-10-21
2019-12-03
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Looking for 122111-03-9 / Gemcitabine API manufacturers, exporters & distributors?

Gemcitabine manufacturers, exporters & distributors 1

91

PharmaCompass offers a list of Gemcitabine 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 Gemcitabine manufacturer or Gemcitabine supplier for your needs.

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

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

API | Excipient name

Gemcitabine

Synonyms

Gemcitabine hcl, 122111-03-9, Gemzar, Ly188011 hydrochloride, Gemcitabine (hydrochloride), 2'-deoxy-2',2'-difluorocytidine monohydrochloride

Cas Number

122111-03-9

Unique Ingredient Identifier (UNII)

U347PV74IL

About Gemcitabine

A deoxycytidine antimetabolite used as an antineoplastic agent.

Gemcitabine Hydrochloride Manufacturers

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

Gemcitabine Hydrochloride Suppliers

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

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

Gemcitabine Hydrochloride Manufacturers | Traders | Suppliers

Gemcitabine Hydrochloride Manufacturers, Traders, Suppliers 1
24

We have 63 companies offering Gemcitabine Hydrochloride

Get in contact with the supplier of your choice:

  1. Dr. Reddy's Laboratories
  2. DKSH
  3. LGM Pharma
  4. HRV Global Life Sciences
  5. Sigmak Lifesciences
  6. Arch Pharmalabs
  7. Archimica
  8. Aspen Biopharma Labs
  9. Beijing Fukangren Biopharmaceutical
  10. Beijing Lunarsun Pharmaceutical Co., Ltd
  11. Benzo Chem Industries Pvt. Ltd.
  12. Biesterfeld Spezialchemie GmbH
  13. Bo-Chem Pvt Ltd
  14. ChemGenix Laboratories Pvt Ltd
  15. Cipla
  16. Dishman Carbogen Amcis
  17. Eli Lilly
  18. Emcure Pharmaceuticals
  19. Farmhispania
  20. Fresenius Kabi AB Brunna
  21. Fresenius Kabi AG
  22. Fresenius Kabi Oncology Limited
  23. Fuan Pharmaceutical
  24. Fujian South Pharmaceutical
  25. GLAND CHEMICALS PRIVATE LIMITED
  26. Guangzhou Tosun Pharmaceutical
  27. Hangzhou Think Chemical Co.Ltd
  28. Hansoh Pharma
  29. Hetero Drugs
  30. Hoventa Pharma
  31. Intas Pharmaceuticals
  32. JARI Pharmaceutical Co., Ltd.
  33. Jiangsu Chiatai Qingjiang Pharmaceutical
  34. Jin Dun Medical
  35. Kekule Pharma
  36. Laurus Labs
  37. Mac-Chem Products (India) Pvt.Ltd
  38. MSN Laboratories
  39. Mustafa Nevzat Ilac Sanayi A S
  40. NEWEDGE Overseas
  41. NINGBO TEAM PHARMACEUTICAL CO., LTD. CN 315 201 Ningbo
  42. Nishchem International Pvt. Ltd
  43. Olon S.p.A
  44. PharmaEssentia
  45. Plantex Ltd.
  46. Qilu Pharmaceutical
  47. Sakar Healthcare
  48. ScinoPharm Taiwan, Ltd
  49. Shandong Anhong Pharmaceutical
  50. Shenzhen Haorui
  51. Shilpa Medicare
  52. Sun Pharmaceutical Industries Limited
  53. Synthland
  54. Tecoland Corporation
  55. Teva API
  56. Teva Pharmaceutical Industries
  57. Vannsh Life Sciences
  58. Viatris
  59. Vinkem Labs Ltd
  60. Yangtze River Pharmaceutical Group
  61. Zhejiang Hisun Pharmaceutical
  62. Zydus Lifesciences
  63. Zyphars Biopharmaceuticals
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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