Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1Seqens
03 1Supriya Lifescience
04 1Alkem Laboratories
05 1Arevipharma
06 1Maithri Drugs
07 1UQUIFA
01 1Brazil
02 1France
03 1Germany
04 3India
05 1Spain
01 6Active
02 1Blank
01 4Valid
02 3Blank
01 7Blank
01 1WC-0218
02 6Blank
Nortec Quimica is the largest API manufacturer in Latin America.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2023-02-22
Pay. Date : 2023-01-31
DMF Number : 37647
Submission : 2022-12-09
Status : Active
Type : II
NDC Package Code : 59014-0020
Start Marketing Date : 2022-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16737
Submission : 2003-07-31
Status : Active
Type : II
Certificate Number : CEP 2017-216 - Rev 02
Issue Date : 2023-11-08
Type : Chemical
Substance Number : 1742
Status : Valid
NDC Package Code : 54382-123
Start Marketing Date : 2001-07-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : CA |
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36426
Submission : 2021-11-08
Status : Active
Type : II
Certificate Number : R0-CEP 2018-198 - Rev 00
Issue Date : 2021-03-01
Type : Chemical
Substance Number : 1742
Status : Valid
Date of Issue : 2022-06-29
Valid Till : 2025-07-02
Written Confirmation Number : WC-0218
Address of the Firm :
NDC Package Code : 61281-8300
Start Marketing Date : 2015-06-15
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ASMF |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37012
Submission : 2022-08-04
Status : Active
Type : II
Certificate Number : CEP 2022-319 - Rev 00
Issue Date : 2024-05-03
Type : Chemical
Substance Number : 1742
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-10-25
Pay. Date : 2022-10-14
DMF Number : 37461
Submission : 2022-09-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-01-30
Pay. Date : 2022-12-01
DMF Number : 36990
Submission : 2022-11-04
Status : Active
Type : II
Certificate Number : R0-CEP 2022-404 - Rev 00
Issue Date : 2023-06-21
Type : Chemical
Substance Number : 1742
Status : Valid
NDC Package Code : 10920-700
Start Marketing Date : 2022-01-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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