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

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01 Dr. Reddy's Laboratories (1)

02 Arch Pharmalabs (2)

03 Archimica (1)

04 Benzo Chem Industries Pvt. Ltd. (1)

05 Cipla (1)

06 Dishman Carbogen Amcis (1)

07 Emcure Pharmaceuticals (2)

08 Fresenius Kabi AB Brunna (1)

09 GLAND CHEMICALS PRIVATE LIMITED (1)

10 Hansoh Pharma (2)

11 Hetero Drugs (1)

12 Intas Pharmaceuticals (2)

13 JARI Pharmaceutical Co., Ltd. (1)

14 Laurus Labs (1)

15 MSN Laboratories (1)

16 Olon S.p.A (1)

17 PharmaEssentia (1)

18 ScinoPharm Taiwan, Ltd (1)

19 Shilpa Medicare (2)

20 Sun Pharmaceutical Industries Limited (1)

21 Teva API (2)

22 Viatris (1)

23 Yangtze River Pharmaceutical Group (1)

24 Zhejiang Hisun Pharmaceutical (1)

25 Zydus Lifesciences (1)

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01 GEMCITABINE HYDROCHLORIDE (7)

02 GEMCITABINE HYDROCHLORIDE (A-MESYLRIBOSE PROCESS) (1)

03 GEMCITABINE HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE (1)

04 GEMCITABINE HYDROCHLORIDE USP (16)

05 GEMCITABINE HYDROCHLORIDE USP (CODE: GMI) (1)

06 GEMCITABINE HYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) (1)

07 GEMCITABINE HYDROCHLORIDE USP (PROCESS -2) (1)

08 GEMCITABINE HYDROCHLORIDE USP (PROCESS II) (1)

09 GEMCITABINE HYDROCHLORIDE USP (PROCESS-III) (1)

10 GEMCITABINE HYDROCHLORIDE USP [ROUTE CODE - "GH"] (1)

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01 China (6)

02 India (18)

03 Israel (2)

04 Italy (2)

05 Sweden (1)

06 Taiwan (1)

07 U.S.A (1)

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01 Active (21)

02 Inactive (10)

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01 Complete (13)

02 Blank (18)

URL Supplier Web Content
23633
Active
2010-03-31
N/A
II
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23339
Active
2009-12-04
N/A
II
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21399
Active
2008-04-22
Complete
2013-02-08
2012-12-19
II
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22229
Active
2008-11-26
N/A
II
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22748
Active
2009-04-15
N/A
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22800
Active
2009-05-16
Complete
2012-11-23
2012-11-16
II
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19053
Active
2005-12-19
Complete
2014-01-14
2013-11-21
II
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19427
Active
2006-05-16
N/A
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20979
Active
2007-10-29
Complete
2012-12-20
2012-12-03
II
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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 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 USDMF

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

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

click here to find a list of Gemcitabine 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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