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List of Drug Master Files (KDMF) for Gemcitabine Hydrochloride Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Dr. Reddy's Laboratories Limited (1)

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

03 Dr. Reddy's Laboratories Ltd.; (2)

04 Evonik Corporation (1)

05 Euticals SpA (1)

06 Fresenius Kabi Oncology Ltd. (2)

07 Hetero Labs LIMITED (1)

08 Hetero Labs Limited (1)

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

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

11 Kyungbo Pharmaceutical Co., Ltd. (1)

12 Laurus Labs Limited (8)

13 Laurus Labs Private Limited (2)

14 Leeyeon Pharmaceutical Co., Ltd. (1)

15 Plantex Ltd. (1)

16 ScinoPharm Taiwan Ltd (1)

17 ScinoPharm Taiwan, Ltd. (1)

18 Shilpa Medicare Limited (1)

19 Shilpa Pharma Lifesciences Limited (2)

20 Sun Pharmaceutical Industries Ltd. (1)

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01 Alvogen Korea Co., Ltd. (1)

02 Boryeong Co., Ltd. (1)

03 Chong Kun Dang Co., Ltd. (1)

04 Dasan Pharmaceutical Co., Ltd. (1)

05 Iksoo Pharmaceutical Co., Ltd. (1)

06 Korea United Pharmaceutical Co., Ltd. (2)

07 Kyungbo Pharmaceutical Co., Ltd. (1)

08 Leesung International Co., Ltd. (2)

09 Leeyeon Pharmaceutical Co., Ltd. (2)

10 Masung LS Co., Ltd. (1)

11 Pfizer Pharmaceuticals Korea Co., Ltd. (2)

12 Pharmapia Co., Ltd. (2)

13 Repure Healthcare Co., Ltd. (1)

14 Samo Pharmaceutical Co., Ltd. (3)

15 Sampoong Pharmachem Co., Ltd. (1)

16 Samyang Holdings Co., Ltd. (1)

17 Sandoz Korea Co., Ltd. (1)

18 Sangjin Trading Co., Ltd. (2)

19 Shinpoong Pharmaceutical Co., Ltd. (1)

20 Sungwoo Chemical Co., Ltd. (1)

21 Wonpoong Pharmaceutical Co., Ltd. (1)

22 Yuhan Corporation (2)

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01 Gemcitabine hydrochloride (7)

02 gemcitabine hydrochloride (24)

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01 China (2)

02 Germany (1)

03 India (20)

04 Israel (1)

05 Italy (1)

06 South Korea (1)

07 Sweden (2)

08 Taiwan (2)

09 Blank (1)

Korea United Pharmaceutical Co., Ltd.
2012-05-18
20070928-86-D-51-03(3)
Dr. Reddy's Laboratories ...
India
CTO - Unit-I, Plot Nos. 1...
URL Supplier Web Content
Boryeong Co., Ltd.
2007-12-28
20071228-86-D-24-04
Evonik Corporation
U.S.A
Tippecanoe Laboratories L...
Sangjin Trading Co., Ltd.
2007-09-28
20070928-86-D-51-03
Dr. Reddy's Laboratories ...
India
CTO - Unit-I, Plot Nos. 1...
Yuhan Corporation
2011-05-31
20070928-86-D-51-03(1)
Dr. Reddy's Laboratories ...
India
CTO - Unit-I, Plot Nos. 1...
Shinpoong Pharmaceutical Co., Ltd.
2011-07-29
20070928-86-D-51-03(2)
Dr. Reddy's Laboratories ...
India
CTO - Unit-I, Plot Nos. 1...
URL Supplier Web Content
Sampoong Pharmachem Co., Ltd.
2021-06-14
20210614-86-D-158-23
Jiangsu Hansoh Pharmaceut...
China
Kaitai Road, Dapu Industr...
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URL Supplier Web Content
Samyang Holdings Co., Ltd.
2021-07-13
20110516-86-D-100-15(6)
Laurus Labs Limited
India
Plot No. 21, Jawaharlal N...
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Iksoo Pharmaceutical Co., Ltd.
2021-03-31
20110516-86-D-100-15(5)
Laurus Labs Limited
India
Plot No.21, Jawaharlal Ne...
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Samo Pharmaceutical Co., Ltd.
2022-12-05
20221205-86-D-160-25
ScinoPharm Taiwan, Ltd.
Taiwan
No. 1, Nan-Ke 8th Road, S...
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Repure Healthcare Co., Ltd.
2021-07-11
20210711-86-D-159-24
Sun Pharmaceutical Indust...
India
A-7/A-8, MIDC Industrial ...
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Looking for 122111-03-9 / Gemcitabine API manufacturers, exporters & distributors?

Gemcitabine manufacturers, exporters & distributors 1

91

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 Hydrochloride Manufacturers

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

Gemcitabine Hydrochloride Suppliers

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

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

Gemcitabine Hydrochloride KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Gemcitabine Hydrochloride Drug Master File in Korea (Gemcitabine Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemcitabine Hydrochloride. The MFDS reviews the Gemcitabine Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Gemcitabine Hydrochloride KDMF to evaluate the safety and efficacy of the drug.

After submitting a Gemcitabine Hydrochloride KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Gemcitabine Hydrochloride API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Gemcitabine Hydrochloride suppliers with KDMF on PharmaCompass.

Gemcitabine Hydrochloride Manufacturers | Traders | Suppliers

Gemcitabine Hydrochloride 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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