Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Transo-Pharm USA LLC
03 1Hubei Gedian Humanwell Pharmaceutical
04 1Medichem S.A
05 1Shandong Loncom Pharmaceutical
06 1Aurobindo Pharma Limited
07 1Beijing Breathgreen Healthcare
08 1Beijing Fukangren Biopharmaceutical
09 1Beijing Sjar Technology Development
10 1Cipla
11 1MSN Laboratories
12 1Maithri Drugs
13 1Mankind Pharma
14 1Sichuan Renan Pharmaceutical
01 6China
02 5India
03 2Spain
04 1U.S.A
01 6Active
02 8Blank
01 14Blank
01 14Blank
01 1WC-0349
02 13Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-09-01
Pay. Date : 2022-03-17
DMF Number : 36481
Submission : 2022-07-27
Status : Active
Type : II
NDC Package Code : 64567-0029
Start Marketing Date : 2022-01-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF, CN |
Hubei Gedian Humanwell focuses on R&D, production, & sales of fertility regulation drugs & steroidal APIs.
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-10
Pay. Date : 2022-04-11
DMF Number : 36861
Submission : 2022-04-19
Status : Active
Type : II
NDC Package Code : 53296-0127
Start Marketing Date : 2020-11-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-25
Pay. Date : 2022-06-01
DMF Number : 36771
Submission : 2022-02-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-12
Pay. Date : 2022-05-26
DMF Number : 37139
Submission : 2022-05-27
Status : Active
Type : II
NDC Package Code : 59651-683
Start Marketing Date : 2023-12-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-05-20
Pay. Date : 2022-05-13
DMF Number : 36737
Submission : 2022-05-06
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-07-25
Pay. Date : 2022-06-17
DMF Number : 36767
Submission : 2022-03-31
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 : 54893-0122
Start Marketing Date : 2022-01-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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