Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
01 1Omgene Life Sciences Pvt. Ltd
02 1Rochem International Inc
03 1HRV Global Life Sciences
04 2Apicore LLC
05 1Apino Pharma
06 1Auro Peptides Limited
07 1Aurobindo Pharma Limited
08 1Chinese Peptide Company
09 1Fresenius Kabi Anti-Infectives
10 1Hansoh Pharma
11 1Hybio Pharmaceutical
12 1Jin Dun Medical
13 1Lianyungang Runzhong Pharmaceutical Co Ltd
14 1Piramal Pharma Solutions
15 1Shenzhen JYMed Technology
16 1Tecoland Corporation
01 7China
02 6India
03 1Italy
04 3U.S.A
01 8Active
02 9Blank
01 17Blank
01 17Blank
01 17Blank
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-09-08
Pay. Date : 2020-08-07
DMF Number : 35078
Submission : 2020-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37005
Submission : 2023-04-19
Status : Active
Type : II
NDC Package Code : 42973-343
Start Marketing Date : 2022-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-02-24
Pay. Date : 2021-09-17
DMF Number : 36216
Submission : 2022-01-27
Status : Active
Type : II
NDC Package Code : 66529-0017
Start Marketing Date : 2019-09-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-08
Pay. Date : 2020-10-19
DMF Number : 35257
Submission : 2020-10-15
Status : Active
Type : II
NDC Package Code : 61662-0015
Start Marketing Date : 2020-01-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-06-27
Pay. Date : 2022-12-05
DMF Number : 36499
Submission : 2023-01-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38904
Submission : 2023-09-27
Status : Active
Type : II
NDC Package Code : 14403-0019
Start Marketing Date : 2024-06-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-09
Pay. Date : 2019-03-01
DMF Number : 33550
Submission : 2019-02-21
Status : Active
Type : II
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