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List of API Suppliers of Gemcitabine API listed on PharmaCompass.com

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USDMF

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Japanese DMF

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Written Confirmation

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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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HRV Global Life Sciences Company Banner

Biotechgate Digital

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Sigmak Lifesciences CB

Biotechgate Digital

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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

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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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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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Application Number
20979
Status
Active
Fees Paid
Reviewed
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2007-10-29
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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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Application Number
23516
Status
Inactive
Fees Paid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2010-02-12
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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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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

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Written Confirmation

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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

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Written Confirmation

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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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Application Number
24278
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE
Issue/Submission Date
2010-10-14
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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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Application Number
23433
Status
Inactive
Fees Paid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2010-01-06
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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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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
31481
Status
Active
Fees Paid
Reviewed
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2017-03-24
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USDMF

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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

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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
23633
R0-CEP 2011-023 - Rev 01
Status
Active
Fees Paid
N/A
Withdrawn by EDQM Failure to CEP procedure
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride, Product ...
Issue/Submission Date
2010-03-31
2014-04-25
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USDMF

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Application Number
23801
R0-CEP 2011-025 - Rev 01
Status
Active
Fees Paid
N/A
Withdrawn by EDQM Failure to CEP procedure
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP (CODE...
Gemcitabine hydrochloride, Product ...
Issue/Submission Date
2010-05-26
2014-04-25
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Application Number
27442
R1-CEP 2013-226 - Rev 00
Indian CDSCO WC-0138
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Expired
2022-08-08
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride
Gemcitabine Hydrochloride IH (BP/US...
Issue/Submission Date
2013-09-13
2020-05-12
2019-08-09
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USDMF

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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

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

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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

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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

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Written Confirmation

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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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Application Number
23833
Status
Inactive
Fees Paid
N/A
 
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Issue/Submission Date
2010-05-26
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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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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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Application Number
R1-CEP 2007-063 - Rev 00
Status
Valid
 
Filing Details
Gemcitabine hydrochloride
Issue/Submission Date
2014-11-07
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Application Number
CEP 2023-271 - Rev 00
Status
Valid
 
Filing Details
Gemcitabine hydrochloride, Alternat...
Issue/Submission Date
2023-12-06
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Application Number
Indian CDSCO WC-0135
Status
 
Expired
2022-07-02
Filing Details
Gemcitabine Hydrochloride BP/USP/Ph...
Issue/Submission Date
2019-07-22
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Application Number
R1-CEP 2012-080 - Rev 01
Status
Valid
 
Filing Details
Gemcitabine hydrochloride, Alternat...
Issue/Submission Date
2019-10-08
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Application Number
R1-CEP 2008-131 - Rev 04
Indian CDSCO WC-0115
Status
Valid
 
Expired
2022-07-07
Filing Details
Gemcitabine hydrochloride
Gemcitabine Hydrochloride (Ph. Eur....
Issue/Submission Date
2022-02-11
2019-07-08
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Application Number
R1-CEP 2008-161 - Rev 02
Status
Valid
 
Filing Details
Gemcitabine hydrochloride
Issue/Submission Date
2021-12-20
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Application Number
Indian CDSCO WC-0275
Status
 
Expired
2023-08-01
Filing Details
gemcitabin hydrochloride
Issue/Submission Date
2021-01-22
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Application Number
R0-CEP 2015-054 - Rev 00
224MF10027
Status
Expired
 
Filing Details
Gemcitabine hydrochloride, Process-...
Gemcitabine hydrochloride at 2nd Fl...
Issue/Submission Date
2015-07-31
2012-02-07
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Application Number
R1-CEP 2013-218 - Rev 02
Status
Valid
 
Filing Details
Gemcitabine hydrochloride, alpha-Me...
Issue/Submission Date
2021-12-20
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Application Number
R1-CEP 2011-032 - Rev 01
220MF10259
Status
Valid
 
Filing Details
Gemcitabine hydrochloride
Gemcitabine hydrochloride at Balmes...
Issue/Submission Date
2017-09-27
2008-12-22
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Application Number
R1-CEP 2009-208 - Rev 02
Status
Valid
 
Filing Details
Gemcitabine hydrochloride
Issue/Submission Date
2020-11-02
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Application Number
R1-CEP 2009-042 - Rev 01
Status
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Filing Details
Gemcitabine hydrochloride
Issue/Submission Date
2015-10-16
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  • INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
  • SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

Looking for 122111-03-9 / Gemcitabine API manufacturers, exporters & distributors?

Gemcitabine manufacturers, exporters & distributors 1

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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 Manufacturers

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

Gemcitabine Suppliers

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

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

Gemcitabine Manufacturers | Traders | Suppliers

Gemcitabine Manufacturers, Traders, Suppliers 1
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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