Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
01 1Aptra Synthesis
02 1Anuh Pharma LTD
03 1F. Hoffmann-La Roche
04 1Hanways Chempharm
05 1Innova Remedies
06 1Ipca Laboratories
07 2Mangalam Drugs & Organics Ltd
08 1Roche Diagnostics GmbH
09 1Shanghai Ziyuan Pharmaceutical
10 1Sibbiotech
01 2China
02 1Germany
03 6India
04 1Russia
05 1Switzerland
01 3Inactive
02 8Blank
01 3Valid
02 8Blank
01 11Blank
01 1WC-0086
02 1WC-0091
03 1WC-0167
04 1WC-0321
05 1WC-0473
06 6Blank
Aptra Synthesis produces APIs, Pellets (Semi-finished Formulations), and Intermediates.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16512
Submission : 2003-03-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17809
Submission : 2004-11-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22910
Submission : 2009-08-10
Status : Inactive
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-02
Written Confirmation Number : WC-0091
Address of the Firm :
Date of Issue : 2018-12-10
Valid Till : 2021-12-09
Written Confirmation Number : WC-0321
Address of the Firm :
Certificate Number : R1-CEP 2000-066 - Rev 04
Issue Date : 2015-09-24
Type : Chemical
Substance Number : 740
Status : Valid
Date of Issue : 2020-06-11
Valid Till : 2023-06-10
Written Confirmation Number : WC-0473
Address of the Firm :
Certificate Number : CEP 2022-457 - Rev 00
Issue Date : 2024-02-23
Type : Chemical
Substance Number : 740
Status : Valid
Date of Issue : 2020-03-18
Valid Till : 2023-03-01
Written Confirmation Number : WC-0086
Address of the Firm :
NDC Package Code : 64677-0003
Start Marketing Date : 2015-04-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R0-CEP 2021-186 - Rev 00
Issue Date : 2022-10-27
Type : Chemical
Substance Number : 740
Status : Valid
Date of Issue : 2022-10-27
Valid Till : 2025-07-22
Written Confirmation Number : WC-0167
Address of the Firm :
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