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 1Granules India Limited
07 1Actavis Inc
08 1Active Pharma
09 1Aktin Pharmaceuticals
10 1Apotex Pharmachem
11 1Corden Pharma Bergamo S.p.A
12 1Guangzhou Tosun Pharmaceutical
13 1Hetero Drugs
14 1JPN Pharma
15 1Nishchem International Pvt. Ltd
16 1Osmopharm
17 1Par Pharmaceutical
18 1Permachem
19 1Permachem Asia, Ltd
20 1Ryoto Fine Co
21 1Sagami Chemical Industry
22 1Sandoz B2B
23 1Souvin Pharmaceuticals Pvt. Ltd
24 1Sun Pharmaceutical Industries Limited
25 1Symed Labs
26 1Synergene Active Ingredients Pvt Ltd
27 2Unichem Laboratories Limited
28 1Unipex
29 1Viatris
30 1Zim Laboratories
31 1Zydus Lifesciences
01 1Canada
02 2China
03 1Czech Republic
04 1France
05 15India
06 1Ireland
07 1Italy
08 5Japan
09 2Switzerland
10 3U.S.A
01 9Active
02 4Inactive
03 19Blank
01 2Valid
02 30Blank
01 1217MF10718
02 1218MF10572
03 1222MF10064
04 1227MF10142
05 1303MF10146
06 1305MF10008
07 26Blank
01 1WC-0024
02 1WC-0035a
03 1WC-0062
04 1WC-0063
05 1WC-0128
06 1WC-0157
07 1WC-0168
08 1WC-0382A4
09 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
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
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 : 15739
Submission : 2001-11-12
Status : Active
Type : II
Date of Issue : 2022-06-30
Valid Till : 2025-07-28
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 : 2018-08-14
Pay. Date : 2018-07-17
DMF Number : 15727
Submission : 2001-10-31
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 9242
Submission : 1991-07-16
Status : Inactive
Type : II
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