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List of Drug Master Files (JDMF) for Gemcitabine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Dr. Reddy's Laboratories Ltd. (1)

02 Farmhispania S. A. (1)

03 Fresenius Kabi Oncology Ltd. (1)

04 Hetero Labs Limited (1)

05 Jiangsu Chiatai Qingjiang Pharmaceutical Co. , Ltd. (1)

06 Jiangsu Hansoh Pharmaceutical Group Co. , Ltd. (1)

07 LAURUS LABS LIMITED. (1)

08 LAURUS LABS PRIVATE LIMITED. (1)

09 Plantex Ltd. (1)

10 SHILPA MEDICARE LIMITED. (1)

11 SUN PHARMACEUTICAL INDUSTRIES LIMITED. (1)

12 ScinoPharm Taiwan, Ltd. (1)

13 Shandong Anhong Pharmaceutical Co. , Ltd. (1)

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01 GEMCITABINE HYDROCHLORIDE (2)

02 Gemcitabine Hydrochloride (3)

03 Gemcitabine hydrochloride (5)

04 Gemcitabine hydrochloride (1)

05 Gemcitabine hydrochloride "Teva" (1)

06 Gemcitabine hydrochloride [D] (1)

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01 China (3)

02 Germany (1)

03 India (6)

04 Israel (1)

05 Spain (1)

06 Taiwan (1)

URL Supplier Web Content
220MF10259
Balmes 85, Atico, 08008 (Barcelona)...
2014-01-08
2008-12-22
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229MF10063
9 Dongjin Road, Economic & Technica...
2018-03-30
2017-03-07
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230MF10173
7-2-A2,Hetero Corporate,Industrial ...
2018-12-21
2018-12-21
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225MF10174
No. 9 Hantai North Road, Qinghe Dis...
2013-08-28
2013-08-28
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230MF10069
2nd Floor, Serene Chambers, Road No...
2018-06-05
2018-06-05
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224MF10027
2nd Floor, Serene Chambers, Road No...
2013-05-22
2012-02-07
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221MF10023
No. 1, Nan-Ke 8th Road, Shan-Hua, T...
2021-09-17
2009-01-28
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230MF10056
No. 29 Huayuan Street Linyi County,...
2018-04-23
2018-04-23
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221MF10017
10/80, RAJENDRA GUNJ, RAICHUR-584 1...
2014-11-17
2009-01-13
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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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Gemcitabine Drug Master File in Japan (Gemcitabine JDMF) empowers Gemcitabine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Gemcitabine JDMF during the approval evaluation for pharmaceutical products. At the time of Gemcitabine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Gemcitabine suppliers with JDMF 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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