Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
01 1Aarti Pharmalabs
02 1Macsen Labs
03 1Amara Labs
04 1Apotex Pharmachem
05 1Cipla
06 1Emcure Pharmaceuticals
07 1Guangzhou Tosun Pharmaceutical
08 1Katwijk Chemie
09 1SNA Healthcare
10 1Taro Pharmaceutical Industries
11 1Zydus Lifesciences
01 1Canada
02 1China
03 7India
04 1Netherlands
05 1U.S.A
01 5Active
02 1Inactive
03 5Blank
01 2Valid
02 9Blank
01 11Blank
01 1WC-0084
02 1WC-0140
03 1WC-295
04 8Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39766
Submission : 2024-04-16
Status : Active
Type : II
Certificate Number : CEP 2024-124 - Rev 00
Issue Date : 2024-10-09
Type : Chemical
Substance Number : 2236
Status : Valid
Date of Issue : 2024-05-20
Valid Till : 2027-05-20
Written Confirmation Number : WC-295
Address of the Firm :
NDC Package Code : 15308-2908
Start Marketing Date : 2023-04-16
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (360kg/360kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
Macsen Labs, a leader in Chemistry since 1952, specializing in APIs, specialty and fine chemicals, and dyes.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10867
Submission : 1994-04-12
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-09
Pay. Date : 2015-03-31
DMF Number : 28983
Submission : 2015-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21640
Submission : 2008-05-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-16
Pay. Date : 2019-09-25
DMF Number : 14335
Submission : 1999-08-06
Status : Active
Type : II
Certificate Number : R0-CEP 2020-354 - Rev 00
Issue Date : 2022-04-19
Type : Chemical
Substance Number : 2236
Status : Valid
NDC Package Code : 17349-0023
Start Marketing Date : 2018-03-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14910
Submission : 2000-06-01
Status : Inactive
Type : II
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0084
Address of the Firm :
Date of Issue : 2022-06-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0140
Address of the Firm :
A Ferriprox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ferriprox, including repackagers and relabelers. The FDA regulates Ferriprox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ferriprox API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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