Nortec Quimica is the largest API manufacturer in Latin America.
01 1Nortec Quimica
02 1Zeon Pharma Industries India Pvt Ltd
03 2Harman Finochem
04 1KUNSHAN ORIENTAL PHARMACEUTICAL CO LTD
05 1Katwijk Chemie
06 1Nippi
07 1Recordati
08 1Swati Spentose
01 1Brazil
02 1China
03 4India
04 1Italy
05 1Japan
06 1Netherlands
01 2Active
02 7Blank
01 1Valid
02 8Blank
01 1217MF10615
02 1218MF10527
03 7Blank
01 1WC-0044
02 1WC-0045
03 1WC-0165
04 6Blank
Nortec Quimica is the largest API manufacturer in Latin America.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23226
Submission : 2009-10-29
Status : Active
Type : II
NDC Package Code : 12711-4444
Start Marketing Date : 2009-10-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20434
Submission : 2007-03-25
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0045
Address of the Firm :
NDC Package Code : 66064-1030
Start Marketing Date : 2007-03-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm :
NDC Package Code : 66064-1030
Start Marketing Date : 2007-03-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2010-244 - Rev 01
Issue Date : 2018-11-05
Type : Chemical
Substance Number : 1253
Status : Valid
Registration Number : 218MF10527
Registrant's Address : Snijderstraat 6,2222 BA, Katwijk, ZH The Netherlands
Initial Date of Registration : 2006-05-18
Latest Date of Registration : --
NDC Package Code : 17349-0007
Start Marketing Date : 1984-06-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-07-08
Valid Till : 2022-07-08
Written Confirmation Number : WC-0165
Address of the Firm :
NDC Package Code : 52119-007
Start Marketing Date : 2012-08-20
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 217MF10615
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2005-09-14
Latest Date of Registration : --
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