Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1HRV Global Life Sciences
03 1Curia
04 1HONOUR LAB LTD
05 1Hetero Drugs
06 1ORGANICA Feinchemie GmbH Wolfen
07 1Sionc Pharmaceuticals
08 2Vasudha Pharma Chem
01 1Germany
02 7India
03 1U.S.A
01 4Active
02 1Inactive
03 4Blank
01 9Blank
01 9Blank
01 1WC-0183A3-4
02 1WC-0183nA2
03 7Blank
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-05
Pay. Date : 2015-04-08
DMF Number : 28740
Submission : 2014-10-31
Status : Active
Type : II
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-04-24
Pay. Date : 2020-01-09
DMF Number : 34403
Submission : 2020-04-09
Status : Active
Type : II
NDC Package Code : 69037-0053
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 32737
Submission : 2018-07-25
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 : 66577-031
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 : 2014-04-25
Pay. Date : 2013-05-21
DMF Number : 27165
Submission : 2013-05-22
Status : Active
Type : II
NDC Package Code : 65392-1314
Start Marketing Date : 1969-08-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4686
Submission : 1982-10-15
Status : Inactive
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0183A3-4
Address of the Firm :
NDC Package Code : 66577-031
Start Marketing Date : 2018-12-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 76055-0015
Start Marketing Date : 2019-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Diatrizoate Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diatrizoate Meglumine, including repackagers and relabelers. The FDA regulates Diatrizoate Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diatrizoate Meglumine 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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