Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1Malladi Drugs & Pharmaceuticals Limited
03 1Divis Laboratories
04 1Estechpharma
05 1Formosa Laboratories
06 1Hainan Poly Pharm
07 1Innopharmax
08 1JRC
09 1Jiangsu Hengrui Medicine
10 1Seven Star Pharmaceutical
11 1Sichuan Renan Pharmaceutical
12 2Viwit Pharmaceuticals Limited
01 5China
02 4India
03 1South Korea
04 3Taiwan
01 7Active
02 1Inactive
03 5Blank
01 13Blank
01 13Blank
01 13Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36148
Submission : 2021-07-29
Status : Active
Type : II
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-06-22
Pay. Date : 2022-06-02
DMF Number : 37072
Submission : 2022-05-31
Status : Active
Type : II
NDC Package Code : 14335-310
Start Marketing Date : 2022-05-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-07-29
Pay. Date : 2020-03-13
DMF Number : 34673
Submission : 2020-03-31
Status : Active
Type : II
NDC Package Code : 57884-0037
Start Marketing Date : 2020-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-12-30
Pay. Date : 2019-12-17
DMF Number : 34291
Submission : 2019-12-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39489
Submission : 2024-02-29
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-11-06
Pay. Date : 2019-09-26
DMF Number : 34129
Submission : 2019-09-12
Status : Active
Type : II
NDC Package Code : 66499-0066
Start Marketing Date : 2019-09-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-08-28
Pay. Date : 2024-07-25
DMF Number : 38739
Submission : 2023-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34421
Submission : 2020-10-23
Status : Inactive
Type : II
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