Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1ChemWerth Inc
03 1LGM Pharma
04 1Jai Radhe Sales
05 1ALP Pharm
06 1Alcami
07 2Apicore LLC
08 3Enaltec Labs Private Limited
09 1Guangzhou Tosun Pharmaceutical
10 1Indoco Remedies Limited
11 1Lonza Group
12 1Micro Labs Limited
13 1SENJU PHARMACEUTICAL CO LTD
14 1Trifarma
15 1Viatris
16 1Yonsung Fine Chemicals
01 2China
02 1Czech Republic
03 8India
04 1Italy
05 1Japan
06 1South Korea
07 1Switzerland
08 4U.S.A
01 8Active
02 2Inactive
03 9Blank
01 19Blank
01 1223MF10031
02 1230MF10078
03 17Blank
01 1WC-0110
02 1WC-0110a
03 1WC-0152
04 1WC-0225
05 1WC-0424
06 1WC-0544
07 13Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38922
Submission : 2023-10-18
Status : Active
Type : II
Registration Number : 230MF10078
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 77900 Olomouc Czech Republic
Initial Date of Registration : 2018-07-03
Latest Date of Registration : --
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-17
Pay. Date : 2013-07-09
DMF Number : 24521
Submission : 2011-05-20
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-27
Pay. Date : 2014-01-17
DMF Number : 23653
Submission : 2010-03-15
Status : Active
Type : II
Registration Number : 223MF10031
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2011-03-03
Latest Date of Registration : --
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-09
Pay. Date : 2013-08-28
DMF Number : 25245
Submission : 2011-08-18
Status : Active
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-15
Written Confirmation Number : WC-0152
Address of the Firm :
NDC Package Code : 14445-008
Start Marketing Date : 2013-12-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-04
Pay. Date : 2013-12-23
DMF Number : 27800
Submission : 2013-12-23
Status : Active
Type : II
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0225
Address of the Firm :
NDC Package Code : 42571-281
Start Marketing Date : 2018-10-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-04-23
Pay. Date : 2013-09-20
DMF Number : 25315
Submission : 2011-11-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16414
Submission : 2003-02-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22915
Submission : 2009-06-30
Status : Inactive
Type : II
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