Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
01 1Sanofi
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Curia
04 1HONOUR LAB LTD
05 1Hetero Drugs
06 1ORGANICA Feinchemie GmbH Wolfen
07 1SIGMA TAU
08 1Sionc Pharmaceuticals
09 2Vasudha Pharma Chem
01 1France
02 1Germany
03 6India
04 2U.S.A
01 4Active
02 3Inactive
03 3Blank
01 10Blank
01 10Blank
01 1WC-0183A3-4
02 1WC-0183nA2
03 8Blank
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5355
Submission : 1984-04-11
Status : Inactive
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-06-09
Pay. Date : 2015-04-08
DMF Number : 28739
Submission : 2014-11-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32736
Submission : 2018-07-23
Status : Active
Type : II
Date of Issue : 2022-06-15
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183nA2
Address of the Firm :
NDC Package Code : 66577-032
Start Marketing Date : 2018-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-30
Pay. Date : 2020-01-09
DMF Number : 34430
Submission : 2020-03-06
Status : Active
Type : II
NDC Package Code : 69037-0052
Start Marketing Date : 1982-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-16
Pay. Date : 2013-04-16
DMF Number : 20924
Submission : 2007-10-05
Status : Active
Type : II
NDC Package Code : 65392-1701
Start Marketing Date : 1954-11-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (65kg/65kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5529
Submission : 1984-09-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4731
Submission : 1982-11-30
Status : Inactive
Type : II
NDC Package Code : 76055-0014
Start Marketing Date : 2019-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183A3-4
Address of the Firm :
NDC Package Code : 66577-032
Start Marketing Date : 2018-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Diatrizoate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diatrizoate Sodium, including repackagers and relabelers. The FDA regulates Diatrizoate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diatrizoate Sodium 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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