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

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01 Dr. Reddy's Laboratories (1)

02 LGM Pharma (1)

03 Sun Pharmaceutical Industries Limited (1)

04 HRV Global Life Sciences (1)

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

06 NEWEDGE Overseas (1)

07 Sigmak Lifesciences (1)

08 Teva API (2)

09 Arch Pharmalabs (2)

10 Archimica (1)

11 Aspen Biopharma Labs (1)

12 Beijing Fukangren Biopharmaceutical (1)

13 Beijing Lunarsun Pharmaceutical Co., Ltd (1)

14 Benzo Chem Industries Pvt. Ltd. (1)

15 Biesterfeld Spezialchemie GmbH (1)

16 Bo-Chem Pvt Ltd (1)

17 ChemGenix Laboratories Pvt Ltd (1)

18 Cipla (1)

19 Dishman Carbogen Amcis (2)

20 Eli Lilly (1)

21 Emcure Pharmaceuticals (2)

22 Farmhispania (1)

23 Fresenius Kabi AB Brunna (1)

24 Fresenius Kabi AG (1)

25 Fresenius Kabi Oncology Limited (3)

26 Fuan Pharmaceutical (1)

27 Fujian South Pharmaceutical (1)

28 GLAND CHEMICALS PRIVATE LIMITED (1)

29 Guangzhou Tosun Pharmaceutical (1)

30 Hangzhou Think Chemical Co.Ltd (1)

31 Hansoh Pharma (2)

32 Hetero Drugs (2)

33 Hoventa Pharma (2)

34 Intas Pharmaceuticals (2)

35 JARI Pharmaceutical Co., Ltd. (1)

36 Jiangsu Chiatai Qingjiang Pharmaceutical (1)

37 Jin Dun Medical (1)

38 Kekule Pharma (1)

39 Laurus Labs (2)

40 MSN Laboratories (1)

41 Mustafa Nevzat Ilac Sanayi A S (1)

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

43 Nishchem International Pvt. Ltd (1)

44 Olon S.p.A (1)

45 PharmaEssentia (1)

46 Plantex Ltd. (1)

47 Qilu Pharmaceutical (1)

48 Sakar Healthcare (1)

49 ScinoPharm Taiwan, Ltd (1)

50 Shandong Anhong Pharmaceutical (1)

51 Shenzhen Haorui (1)

52 Shilpa Medicare (2)

53 Synthland (1)

54 Tecoland Corporation (1)

55 Teva Pharmaceutical Industries (2)

56 Vannsh Life Sciences (1)

57 Viatris (1)

58 Vinkem Labs Ltd (1)

59 Yangtze River Pharmaceutical Group (1)

60 Zhejiang Hisun Pharmaceutical (1)

61 Zydus Lifesciences (1)

62 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 Taiwan (1)

09 Turkey (1)

10 U.S.A (4)

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01 Active (21)

02 Inactive (10)

03 Blank (44)

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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 (51)

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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 (62)

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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 (62)

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USDMF

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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
HRV Global Life Sciences Company Banner

EMWA 2024

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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Written Confirmation

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

EMWA 2024

Not Confirmed

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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

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

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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USDMF

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CEP/COS

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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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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

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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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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 HCl Manufacturers

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

Gemcitabine HCl Suppliers

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

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

Gemcitabine HCl Manufacturers | Traders | Suppliers

Gemcitabine HCl 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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