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 1Shandong Boyuan Pharmaceutical
04 1Chunghwa Chemical Synthesis & Biotech
05 2Alembic Pharmaceuticals Limited
06 1Arevipharma
07 1Cdymax
08 1Changzhou Pharmaceutical Factory
09 1Cipla
10 1Fresenius Kabi Oncology Limited
11 1Hetero Drugs
12 1Intas Pharmaceuticals
13 1MSN Laboratories
14 1Natco Pharma
15 1Teva API
16 1Teva Pharmaceutical Industries
17 1Viatris
01 2China
02 1Germany
03 1Hungary
04 10India
05 2Israel
06 1Taiwan
07 1U.S.A
01 4Active
02 1Inactive
03 13Blank
01 18Blank
01 18Blank
01 1WC-0082
02 1WC-0082A11
03 1WC-0349
04 15Blank
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 : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
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 : 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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
Date of Issue : 2021-10-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A11
Address of the Firm :
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