Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
01 1Egis Pharmaceuticals PLC
02 1EUROAPI
03 1LGM Pharma
04 1Dr. Reddy's Laboratories
05 1Jai Radhe Sales
06 2Aarti Pharmalabs
07 1HRV Global Life Sciences
08 1Neuland Laboratories
09 1Farmhispania
10 1Actavis Inc
11 1Apotex Pharmachem
12 1Arch Pharmalabs
13 1Aurobindo Pharma Limited
14 1Cipla
15 1DEAFARMA
16 1Esteve Quimica
17 1Guangzhou Tosun Pharmaceutical
18 1Hengdian Group
19 2Hetero Drugs
20 1Lunan Pharmaceutical
21 2Lupin Ltd
22 1Melody Healthcare Pvt Ltd
23 1Otto Brandes
24 1Prague Scientific
25 1RANBAXY LABORATORIES LIMITED
26 1SMS Pharmaceuticals
27 1Srini Pharmaceuticals
28 1Sun Pharmaceutical Industries Limited
29 1Unimark Remedies Limited
30 1Unipex
31 2Zhejiang Changming Pharmaceuticals
32 1Zhejiang Huahai Pharmaceutical
01 1Canada
02 6China
03 1Czech Republic
04 2France
05 1Germany
06 1Hungary
07 19India
08 1Ireland
09 1Italy
10 2Spain
11 1U.S.A
01 10Active
02 7Inactive
03 19Blank
01 1Expired
02 16Valid
03 1Withdrawn by EDQM Failure to CEP procedure
04 2Withdrawn by Holder
05 16Blank
01 36Blank
01 1WC-0011
02 1WC-0017
03 1WC-0035a
04 1WC-0036
05 1WC-0041
06 1WC-0099
07 1WC-0144
08 1WC-0170
09 1WC-0202
10 1WC-0227
11 26Blank
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Certificate Number : R0-CEP 2020-284 - Rev 01
Issue Date : 2023-02-28
Type : Chemical
Substance Number : 1368
Status : Valid
Certificate Number : R1-CEP 2001-297 - Rev 07
Issue Date : 2021-12-10
Type : Chemical
Substance Number : 1368
Status : Valid
NDC Package Code : 82348-101
Start Marketing Date : 2010-07-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Handok Co., Ltd.
Registration Date : 2024-02-06
Registration Number : 20240206-209-J-1365
Manufacturer Name : EUROAPI Germany GmbH@Sanofi India Limited
Manufacturer Address : Brueningstrasse 50, D711, D712, D721, D725, D731, D743, E610, E614, 65926, Frankfurt am Main, Germany@Plot No L-121, Phase III, GIDC, Verna Industrial Estate, Goa, IN-403722, Verna, Salcete, India
Available Reg Filing : IN, ROW |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-17
Pay. Date : 2019-05-10
DMF Number : 16193
Submission : 2002-10-17
Status : Active
Type : II
Date of Issue : 2022-06-06
Valid Till : 2025-06-25
Written Confirmation Number : WC-0035a
Address of the Firm :
NDC Package Code : 55111-057
Start Marketing Date : 2002-10-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-23
Pay. Date : 2013-07-09
DMF Number : 19714
Submission : 2006-08-28
Status : Active
Type : II
Certificate Number : R1-CEP 2006-040 - Rev 06
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1368
Status : Valid
Date of Issue : 2023-01-06
Valid Till : 2025-07-29
Written Confirmation Number : WC-0099
Address of the Firm :
NDC Package Code : 15308-0300
Start Marketing Date : 2016-08-30
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 : 16647
Submission : 2003-06-10
Status : Active
Type : II
Certificate Number : R1-CEP 2003-219 - Rev 07
Issue Date : 2022-12-16
Type : Chemical
Substance Number : 1368
Status : Valid
Date of Issue : 2022-07-28
Valid Till : 2025-06-16
Written Confirmation Number : WC-0036
Address of the Firm :
NDC Package Code : 58032-0123
Start Marketing Date : 2017-12-13
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 : 18520
Submission : 2005-07-15
Status : Inactive
Type : II
Certificate Number : R1-CEP 2004-224 - Rev 02
Issue Date : 2019-10-17
Type : Chemical
Substance Number : 1368
Status : Valid
NDC Package Code : 17404-1021
Start Marketing Date : 2008-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Certificate Number : R1-CEP 2009-083 - Rev 05
Issue Date : 2022-10-14
Type : Chemical
Substance Number : 1368
Status : Valid
NDC Package Code : 15308-0300
Start Marketing Date : 2016-08-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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