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List of Certificates of Suitability (CEPs) for Gemcitabine Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 DR. REDDY'S LABORATORIES LIMITED Hyderabad IN (1)

02 ARCH PHARMALABS LIMITED Mumbai IN (2)

03 CIPLA LIMITED Mumbai IN (1)

04 Eli Lilly And Company Indianapolis US (1)

05 FARMHISPANIA GROUP (SUISSE) SA Lugano CH (1)

06 FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN (3)

07 FUAN PHARMACEUTICAL GROUP NINGBO TEAM PHARMACEUTICAL CO., LTD. Ningbo CN (1)

08 HETERO LABS LIMITED Hyderabad IN (2)

09 INTAS PHARMACEUTICALS LIMITED Ahmedabad IN (2)

10 JIANGSU HANSOH PHARMACEUTICAL GROUP CO., LTD. Lianyungang City CN (1)

11 LAURUS LABS LIMITED Hyderabad IN (1)

12 LAURUS LABS PRIVATE LIMITED Hyderabad IN (1)

13 SCINOPHARM TAIWAN, LTD. Shan-Hua TW (1)

14 SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN (2)

15 SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN (1)

16 TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL (2)

17 Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN (1)

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01 Gemcitabine hydrochloride (15)

02 Gemcitabine hydrochloride, Alternate Process-2 (1)

03 Gemcitabine hydrochloride, Alternate process (1)

04 Gemcitabine hydrochloride, GA process (1)

05 Gemcitabine hydrochloride, Process III (1)

06 Gemcitabine hydrochloride, Process-2 (2)

07 Gemcitabine hydrochloride, Product code: GAI (1)

08 Gemcitabine hydrochloride, Product code: GMI (1)

09 Gemcitabine hydrochloride, alpha-Mesylribose process (1)

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01 China (3)

02 India (16)

03 Israel (2)

04 Spain (1)

05 Taiwan (1)

06 U.S.A (1)

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01 Expired (1)

02 Valid (19)

03 Withdrawn by EDQM Failure to CEP procedure (2)

04 Withdrawn by Holder (2)

URL Supplier Web Content
R1-CEP 2008-131 - Rev 04
Valid
Chemical
2022-02-11
2306
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R1-CEP 2017-076 - Rev 00
Valid
Chemical
2023-02-28
2306
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R0-CEP 2022-499 - Rev 00
Valid
Chemical
2023-02-28
2306
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R0-CEP 2022-092 - Rev 00
Valid
Chemical
2022-07-13
2306
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R1-CEP 2009-026 - Rev 02
Valid
Chemical
2023-01-24
2306
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R1-CEP 2006-272 - Rev 06
Valid
Chemical
2022-09-08
2306
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CEP 2017-187 - Rev 02
Valid
Chemical
2024-01-04
2306
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R1-CEP 2006-222 - Rev 01
Valid
Chemical
2023-02-23
2306
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R1-CEP 2007-021 - Rev 01
Valid
Chemical
2015-07-28
2306
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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 CEP

A Gemcitabine CEP of the European Pharmacopoeia monograph is often referred to as a Gemcitabine Certificate of Suitability (COS). The purpose of a Gemcitabine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gemcitabine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gemcitabine to their clients by showing that a Gemcitabine CEP has been issued for it. The manufacturer submits a Gemcitabine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gemcitabine CEP holder for the record. Additionally, the data presented in the Gemcitabine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gemcitabine DMF.

A Gemcitabine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gemcitabine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Gemcitabine suppliers with CEP (COS) 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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