Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1LGM Pharma
03 1Metrochem API Private Limited
04 1Dr. Reddy's Laboratories
05 1Jai Radhe Sales
06 1Actavis Inc
07 1Active Pharma
08 1Aktin Chemicals
09 1Apotex Pharmachem
10 1Corden Pharma Bergamo S.p.A
11 1Guangzhou Tosun Pharmaceutical
12 1Hetero Drugs
13 1JPN Pharma
14 1Nishchem International Pvt. Ltd
15 1Osmopharm
16 1Par Pharmaceutical
17 1Permachem
18 1Permachem Asia, Ltd
19 1Ryoto Fine Co
20 1Sagami Chemical Industry
21 1Sandoz B2B
22 1Souvin Pharmaceuticals Pvt. Ltd
23 1Sun Pharmaceutical Industries Limited
24 1Symed Labs
25 1Synergene Active Ingredients Pvt Ltd
26 2Unichem Laboratories Limited
27 1Unipex
28 1Viatris
29 1Zim Laboratories
30 1Zydus Lifesciences
01 1Canada
02 2China
03 1Czech Republic
04 1France
05 14India
06 1Ireland
07 1Italy
08 5Japan
09 2Switzerland
10 3U.S.A
01 9Active
02 4Inactive
03 18Blank
01 2Valid
02 29Blank
01 1217MF10718
02 1218MF10572
03 1222MF10064
04 1227MF10142
05 1303MF10146
06 1305MF10008
07 25Blank
01 1WC-0035a
02 1WC-0062
03 1WC-0063
04 1WC-0128
05 1WC-0157
06 1WC-0168
07 1WC-0382A4
08 24Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-03-03
Pay. Date : 2014-10-14
DMF Number : 15525
Submission : 2001-07-04
Status : Active
Type : II
Registration Number : 227MF10142
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 779 00 Olomouc Czech Republic
Initial Date of Registration : 2015-05-20
Latest Date of Registration : --
NDC Package Code : 63278-0489
Start Marketing Date : 2003-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kwangdong Pharmaceutical Co., Ltd.
Registration Date : 2021-06-21
Registration Number : 20210421-209-J-493(1)
Manufacturer Name : Farmak, as
Manufacturer Address : Na vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
Available Reg Filing : ASMF |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-23
Pay. Date : 2013-04-12
DMF Number : 15699
Submission : 2001-11-02
Status : Active
Type : II
Certificate Number : R0-CEP 2020-281 - Rev 00
Issue Date : 2023-07-05
Type : Chemical
Substance Number : 2578
Status : Valid
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm :
NDC Package Code : 55111-020
Start Marketing Date : 2001-11-02
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 : 15739
Submission : 2001-11-12
Status : Active
Type : II
Date of Issue : 2019-07-29
Valid Till : 2022-07-28
Written Confirmation Number : WC-0063
Address of the Firm :
NDC Package Code : 53747-003
Start Marketing Date : 2001-11-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-09
Pay. Date : 2022-01-27
DMF Number : 33900
Submission : 2019-07-09
Status : Active
Type : II
Certificate Number : R0-CEP 2022-256 - Rev 00
Issue Date : 2023-01-05
Type : Chemical
Substance Number : 2578
Status : Valid
Date of Issue : 2021-06-22
Valid Till : 2022-08-08
Written Confirmation Number : WC-0382A4
Address of the Firm :
NDC Package Code : 66022-0202
Start Marketing Date : 1996-11-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Klasia Co., Ltd.
Registration Date : 2021-10-19
Registration Number : 20211019-209-J-1034
Manufacturer Name : M/s.Symed Labs Ltd (Unit-Ⅰ)
Manufacturer Address : Sy. No. 353, Domadugu Village Gummadidala (Mandal), Sangareddy (Dist.), Telangana State, India.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-17
DMF Number : 15727
Submission : 2001-10-31
Status : Active
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-07
Pay. Date : 2014-04-10
DMF Number : 28176
Submission : 2014-04-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9242
Submission : 1991-07-16
Status : Inactive
Type : II
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