Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
01 1Minakem
02 1Minakem (formerly Delmar Chemicals)
03 1Biophore India Pharmaceuticals Pvt Ltd
04 1Aspen API
05 2Azico Biophore India Pvt. Ltd
06 1Micro Labs Limited
07 1Tokyo Chemical Industry
08 1Blank
01 1Canada
02 1France
03 4India
04 1Japan
05 1Netherlands
06 1Blank
01 4Active
02 2Inactive
03 3Blank
01 9Blank
01 9Blank
01 1WC-0404
02 1WC-0404A2
03 7Blank
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
Minakem is manufacturing small molecules APIs including corticosteroids
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8676
Submission : 1990-08-01
Status : Active
Type : II
NDC Package Code : 11712-007
Start Marketing Date : 1990-08-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-12
Pay. Date : 2017-12-21
DMF Number : 32334
Submission : 2017-12-19
Status : Active
Type : II
Aspen API. More than just an API.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-10
Pay. Date : 2013-12-24
DMF Number : 7982
Submission : 1989-03-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-21
Pay. Date : 2018-03-05
DMF Number : 32514
Submission : 2018-03-01
Status : Active
Type : II
NDC Package Code : 42571-326
Start Marketing Date : 2017-08-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (15kg/15kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9935
Submission : 1992-10-29
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7899
Submission : 1989-01-18
Status : Inactive
Type : II
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404
Address of the Firm :
NDC Package Code : 69575-4008
Start Marketing Date : 2017-12-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-08-17
Valid Till : 2023-06-22
Written Confirmation Number : WC-0404A2
Address of the Firm :
NDC Package Code : 69575-4008
Start Marketing Date : 2017-12-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
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