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 1Medichem S.A
06 1Tenatra Chemie
07 1Arde’s Laboratories
08 1C-Squared Pharma
09 1Centaur Pharmaceuticals
10 1Curia
11 1Darou Pakhsh Pharma Chem
12 2Enaltec Labs Private Limited
13 1FDC
14 1Guangzhou Tosun Pharmaceutical
15 1Hunan Huateng Pharmaceutical Co ltd
16 1Indoco Remedies Limited
17 3Laurus Labs
18 1Lupin Ltd
19 1Maithri Drugs
20 1Micro Labs Limited
21 1Piramal Enterprises Limited
22 1Piramal Pharma Solutions
23 1SNA Healthcare
24 1Sanwa Chemical Industrial
25 1Symed Labs
26 1Unichem Laboratories Limited
27 1Unipex
01 2China
02 1Czech Republic
03 1France
04 1Hong Kong
05 18India
06 1Iran
07 1Ireland
08 1Spain
09 4U.S.A
01 13Active
02 17Blank
01 10Valid
02 20Blank
01 1222MF10073
02 1301MF10101
03 1301MF10111
04 1302MF10029
05 26Blank
01 1WC-0055
02 1WC-0063
03 1WC-0072
04 1WC-0107
05 1WC-0123
06 1WC-0152
07 1WC-0177
08 1WC-0177A
09 1WC-0213
10 1WC-0225
11 1WC-0544
12 19Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-10-26
Pay. Date : 2012-12-19
DMF Number : 15585
Submission : 2001-08-15
Status : Active
Type : II
Certificate Number : CEP 2014-331 - Rev 03
Issue Date : 2024-03-06
Type : Chemical
Substance Number : 2760
Status : Valid
Registration Number : 302MF10029
Registrant's Address : Na vlcinci 16/3 Klasterni Hradisko 779 00 Olomouc Czech Republic
Initial Date of Registration : 2020-02-13
Latest Date of Registration : --
NDC Package Code : 63278-0488
Start Marketing Date : 2002-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hiple Co., Ltd.
Registration Date : 2013-12-20
Registration Number : 20131220-200-I-380-02
Manufacturer Name : Farmak as
Manufacturer Address : Na Vlcinci 16/3, Klasterni Hradisko, 779 00 Olomouc, Czech Republic
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-23
DMF Number : 15601
Submission : 2001-08-27
Status : Active
Type : II
Certificate Number : R1-CEP 2013-353 - Rev 00
Issue Date : 2019-04-24
Type : Chemical
Substance Number : 2760
Status : Valid
NDC Package Code : 53296-0050
Start Marketing Date : 2014-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Hansol Pharma Co., Ltd.
Registration Date : 2024-05-01
Registration Number : 20141201-200-I-451-04(1)
Manufacturer Name : MEDICHEM SA
Manufacturer Address : Pirineus street, 127, Poligon Industrial de Celra, 17460 Celra (Girona), Spain
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22230
Submission : 2008-12-01
Status : Active
Type : II
Certificate Number : R0-CEP 2018-124 - Rev 00
Issue Date : 2020-05-14
Type : Chemical
Substance Number : 2760
Status : Valid
Date of Issue : 2019-10-07
Valid Till : 2022-09-08
Written Confirmation Number : WC-0072
Address of the Firm :
NDC Package Code : 66022-0110
Start Marketing Date : 2013-08-23
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 : 17588
Submission : 2004-08-05
Status : Active
Type : II
Registration Number : 222MF10073
Registrant's Address : Digwal Village (Sy.Nos. 7-70, 70/1 and 70/2), Kohir Mandal, Sangareddy District-502 321, Telangana, India
Initial Date of Registration : 2010-02-25
Latest Date of Registration : --
NDC Package Code : 55679-133
Start Marketing Date : 1999-05-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : AbbVie Korea Inc.
Registration Date : 2012-07-13
Registration Number : 20120713-200-I-93-01
Manufacturer Name : Piramal Pharma Limited
Manufacturer Address : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandal, Sangareddy Dist., 502321 Telangana, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25051
Submission : 2011-07-05
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 : 53747-036
Start Marketing Date : 2011-07-05
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 : 36595
Submission : 2021-12-09
Status : Active
Type : II
Certificate Number : R0-CEP 2021-507 - Rev 00
Issue Date : 2023-07-04
Type : Chemical
Substance Number : 2760
Status : Valid
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