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 1Aarti Pharmalabs
03 1Chunghwa Chemical Synthesis & Biotech
04 1TAPI Technology & API Services
05 2Alembic Pharmaceuticals Limited
06 1Arevipharma
07 1Aurore Life Sciences
08 1Cdymax
09 1Changzhou Pharmaceutical Factory
10 1Cipla
11 1Fresenius Kabi Oncology Limited
12 1Globe Quimica Ltda
13 1Hetero Drugs
14 1Intas Pharmaceuticals
15 1MSN Laboratories
16 1Natco Pharma
17 1Teva Pharmaceutical Industries
18 1Viatris
01 1Brazil
02 1China
03 1Germany
04 1Hungary
05 11India
06 2Israel
07 1Taiwan
08 1U.S.A
01 4Active
02 1Inactive
03 14Blank
01 19Blank
01 19Blank
01 1WC-0082
02 1WC-0082A11
03 1WC-0349
04 16Blank
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status : Active
Type : II
NDC Package Code : 52076-6203
Start Marketing Date : 2017-09-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-03
Pay. Date : 2020-09-25
DMF Number : 35098
Submission : 2020-09-01
Status : Active
Type : II
Date of Issue : 2022-09-02
Valid Till : 2025-05-05
Written Confirmation Number : WC-0349
Address of the Firm :
NDC Package Code : 54893-0101
Start Marketing Date : 2020-08-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-18
Pay. Date : 2021-09-24
DMF Number : 36335
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
Date of Issue : 2021-10-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A11
Address of the Firm :
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
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