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

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$ API Ref.Price (USD/KG) : 4,670Xls
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01 1Dr. Reddy's Laboratories Ltd.

02 1Farmhispania S. A.

03 1Fresenius Kabi Oncology Ltd.

04 1Hetero Labs Limited

05 1Jiangsu Chiatai Qingjiang Pharmaceutical Co. , Ltd.

06 1Jiangsu Hansoh Pharmaceutical Group Co. , Ltd.

07 1LAURUS LABS LIMITED.

08 1LAURUS LABS PRIVATE LIMITED.

09 1SHILPA MEDICARE LIMITED.

10 1SUN PHARMACEUTICAL INDUSTRIES LIMITED.

11 1ScinoPharm Taiwan, Ltd.

12 1Shandong Anhong Pharmaceutical Co. , Ltd.

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

GEMCITABINE HYDROCHLORIDE

Registration Number : 220MF10243

Registrant's Address : 8-2-337, Road No. 3,Banjara Hills,Hyderabad 500 034,TELANGANA,INDIA

Initial Date of Registration : 2008-12-04

Latest Date of Registration : 2024-08-22

Dr Reddy Company Banner

02

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AAPS 2024
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFarmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.

Gemcitabine hydrochloride

Registration Number : 220MF10259

Registrant's Address : Balmes 85, Atico, 08008 (Barcelona), Spain

Initial Date of Registration : 2008-12-22

Latest Date of Registration : 2014-01-08

Farmhispania

03

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Gemcitabine Hydrochloride

Registration Number : 229MF10063

Registrant's Address : 9 Dongjin Road, Economic & Technical Development Zone, Lianyungang, Jiangsu 222069, C...

Initial Date of Registration : 2017-03-07

Latest Date of Registration : 2018-03-30

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04

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Gemcitabine hydrochloride [D]

Registration Number : 230MF10173

Registrant's Address : 7-2-A2,Hetero Corporate,Industrial Estates Sanath Nagar,Hyderabad-500 018 Telangana I...

Initial Date of Registration : 2018-12-21

Latest Date of Registration : 2018-12-21

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05

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Gemcitabine hydrochloride "For manufacturing only"

Registration Number : 225MF10174

Registrant's Address : No. 9 Hantai North Road, Qinghe District, Huai'an City, Jiangsu Province, P. R. China

Initial Date of Registration : 2013-08-28

Latest Date of Registration : 2013-08-28

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06

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Gemcitabine hydrochloride

Registration Number : 224MF10027

Registrant's Address : 2nd Floor, Serene Chambers, Road No#7, Banjara Hills, Hyderabad, Andhra Pradesh, INDI...

Initial Date of Registration : 2012-02-07

Latest Date of Registration : 2013-05-22

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07

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Gemcitabine hydrochloride

Registration Number : 230MF10069

Registrant's Address : 2nd Floor, Serene Chambers, Road No#7, Banjara Hills, Hyderabad, Telangana, INDIA

Initial Date of Registration : 2018-06-05

Latest Date of Registration : 2018-06-05

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08

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Gemcitabine Hydrochloride

Registration Number : 221MF10023

Registrant's Address : No. 1, Nan-Ke 8th Road, Shan-Hua, Tainan 74144, Taiwan

Initial Date of Registration : 2009-01-28

Latest Date of Registration : 2021-09-17

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09

AAPS 2024
Not Confirmed
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AAPS 2024
Not Confirmed

Gemcitabine hydrochloride

Registration Number : 230MF10056

Registrant's Address : No. 29 Huayuan Street Linyi County, Dezhou, Shandong, China

Initial Date of Registration : 2018-04-23

Latest Date of Registration : 2018-04-23

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