Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1ChemWerth Inc
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Veranova
05 1HRV Global Life Sciences
06 1Aurobindo Pharma Limited
07 1Biddle Sawyer Corporation
08 1CHEMO
09 1Emcure Pharmaceuticals
10 1Hunan Huateng Pharmaceutical Co ltd
11 1Industriale Chimica
12 1Intas Pharmaceuticals
13 1Kaken Pharmaceuticals
14 1MSN Laboratories
15 1Sigmapharm Laboratories, LLC
16 1Sionc Pharmaceuticals
17 1Sun Pharmaceutical Industries Limited
18 1Viatris
01 1China
02 1Czech Republic
03 8India
04 1Italy
05 1Japan
06 1Spain
07 5U.S.A
01 13Active
02 5Blank
01 18Blank
01 18Blank
01 1WC-0273
02 1WC-0383A8
03 16Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-04-06
Pay. Date : 2017-10-02
DMF Number : 31858
Submission : 2017-07-24
Status : Active
Type : II
NDC Package Code : 63278-1079
Start Marketing Date : 2000-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-14
Pay. Date : 2017-08-11
DMF Number : 30718
Submission : 2017-08-10
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-18
Pay. Date : 2014-02-12
DMF Number : 27816
Submission : 2014-02-25
Status : Active
Type : II
NDC Package Code : 49812-0261
Start Marketing Date : 2014-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-23
Pay. Date : 2015-09-18
DMF Number : 29722
Submission : 2015-10-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-25
Pay. Date : 2018-06-18
DMF Number : 31158
Submission : 2016-12-30
Status : Active
Type : II
Date of Issue : 2021-02-12
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A8
Address of the Firm :
NDC Package Code : 69766-022
Start Marketing Date : 2016-12-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30794
Submission : 2018-05-30
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-22
Pay. Date : 2014-06-09
DMF Number : 28301
Submission : 2014-06-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-09-20
Pay. Date : 2016-07-06
DMF Number : 30508
Submission : 2016-06-29
Status : Active
Type : II
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