Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Egis Pharmaceuticals PLC
03 1Alkem Laboratories
04 1Aurobindo Pharma Limited
05 1Glenmark Life Sciences
06 1Glenmark Pharmaceuticals
07 1Hetero Drugs
08 1Hikma Pharmaceuticals
09 1Unichem Laboratories Limited
01 1Hungary
02 6India
03 1Spain
04 1United Kingdom
01 6Active
02 3Blank
01 9Blank
01 9Blank
01 1WC-0310
02 1WC-0385
03 7Blank
Inke S.A: APIs manufacturing plant.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-12-16
Pay. Date : 2022-11-14
DMF Number : 34741
Submission : 2020-03-31
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-953
Start Marketing Date : 2020-09-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-16
Pay. Date : 2023-01-25
DMF Number : 36949
Submission : 2022-03-30
Status : Active
Type : II
NDC Package Code : 53747-100
Start Marketing Date : 2022-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-04
Pay. Date : 2022-12-19
DMF Number : 37548
Submission : 2022-12-28
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-02-15
Pay. Date : 2023-02-03
DMF Number : 36951
Submission : 2022-03-28
Status : Active
Type : II
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0385
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-05-16
Pay. Date : 2023-04-12
DMF Number : 38280
Submission : 2023-04-18
Status : Active
Type : II
NDC Package Code : 65977-0140
Start Marketing Date : 2019-12-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-04-28
Pay. Date : 2023-01-09
DMF Number : 37929
Submission : 2023-01-10
Status : Active
Type : II
NDC Package Code : 59651-756
Start Marketing Date : 2023-11-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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