Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
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01 1FARMAK, a.s
02 2EUROAPI
03 1Faran Shimi Pharmaceutical
04 2Alivus Life Sciences
05 1Alkem Laboratories
06 1Apicore
07 1Apotex Pharmachem
08 1DEAFARMA
09 1Esteve Quimica
10 1Glenmark Pharmaceuticals
11 1Guangzhou Tosun Pharmaceutical
12 1Hetero Drugs
13 1Jiangsu Nhwa Pharmaceutical
14 1Mana Pharma SL
15 1ScinoPharm Taiwan Ltd
16 1Standard Chem. & Pharm. Co., Ltd
17 1Sun Pharmaceutical Industries Limited
18 1Syn-Tech Chem. & Pharm
19 1Unipex
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01 1Canada
02 3China
03 1Czech Republic
04 3France
05 7India
06 1Iran
07 1Italy
08 2Spain
09 2Taiwan
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01 7Active
02 1Inactive
03 13Blank
01 21Blank
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01 1224MF10021
02 20Blank
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01 1WC-0040
02 1WC-0057n
03 1WC-0128
04 1WC-0168
05 1WC-0310
06 1WC-0370n
07 15Blank
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01 13025-2-ND
02 13025-5-ND
03 1No. 4692-8-ND
04 1No. 4749-12-ND
05 1No. 703-7-ND
06 16Blank
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01 154871-1098
02 163278-1076
03 165129-1011
04 165977-0045
05 166039-812
06 16Blank
01 21Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
NDC Package Code : 63278-1076
Start Marketing Date : 1996-12-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2013-12-19
Registration Number : No. 4749-12-ND
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Available Reg Filing : ASMF |
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2012-08-31
Registration Number : 3025-5-ND
Manufacturer Name : EUROAPI FRANCE
Manufacturer Address : 4 La Paterie, 63480, Vertolaye, France
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Registrant Name : Sanofi-Aventis Korea Co., Ltd.
Registration Date : 2008-05-07
Registration Number : 3025-2-ND
Manufacturer Name : Sanofi Chimie
Manufacturer Address : Center de production de Vitry-sur-Seine9, Quai Jules Guesde 94403 Vitry SUR Seine Cedex
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22438
Submission : 2009-03-16
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-07
Pay. Date : 2013-04-08
DMF Number : 26147
Submission : 2012-06-08
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-12
Pay. Date : 2013-07-10
DMF Number : 24693
Submission : 2011-02-28
Status : Active
Type : II
Registration Number : 224MF10021
Registrant's Address : Torre Esteve, Pg. de la Zona Franca, 109, 4th floor, 08038 Barcelona - Spain
Initial Date of Registration : 2012-02-01
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23215
Submission : 2009-10-26
Status : Active
Type : II
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm :
NDC Package Code : 65977-0045
Start Marketing Date : 1995-12-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22107
Submission : 2008-10-22
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-812
Start Marketing Date : 2008-10-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : M-Peak Korea Co., Ltd.
Registration Date : 2013-05-16
Registration Number : No. 4692-8-ND
Manufacturer Name : Glenmark Life Sciences Limited
Manufacturer Address : Plot No. 3109, GIDC Industrial Estate, Ankleshwar - 393 002, Dist: Bharuch, Gujarat State, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22596
Submission : 2009-03-05
Status : Inactive
Type : II
Date of Issue : 2024-04-25
Valid Till : 2026-07-25
Written Confirmation Number : WC-0128
Address of the Firm :
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