Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1LGM Pharma
03 1Emcure Pharmaceuticals
04 1Erregierre SpA
05 1MSN Laboratories
06 1Optimus Pharma
07 1Sionc Pharmaceuticals
08 1Solara Active Pharma Sciences
09 1Viatris
01 6India
02 1Italy
03 2U.S.A
01 7Active
02 2Blank
01 9Blank
01 9Blank
01 1WC-0021n
02 1WC-0127
03 1WC-0226
04 1WC-0273
05 5Blank
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 : 2014-06-16
Pay. Date : 2014-06-05
DMF Number : 26446
Submission : 2012-09-26
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-14
Pay. Date : 2018-09-27
DMF Number : 31578
Submission : 2017-07-29
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
NDC Package Code : 72643-022
Start Marketing Date : 2020-04-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-01-05
Pay. Date : 2014-11-20
DMF Number : 24827
Submission : 2011-04-05
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0056
Start Marketing Date : 2010-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-09
Pay. Date : 2016-10-17
DMF Number : 25805
Submission : 2012-03-26
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-854
Start Marketing Date : 2023-12-25
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-03
Pay. Date : 2015-09-18
DMF Number : 24334
Submission : 2011-04-01
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-08-29
Pay. Date : 2015-09-18
DMF Number : 26995
Submission : 2013-03-15
Status : Active
Type : II
NDC Package Code : 49706-2115
Start Marketing Date : 2011-04-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-03-03
Pay. Date : 2021-01-25
DMF Number : 35137
Submission : 2020-12-26
Status : Active
Type : II
NDC Package Code : 59285-035
Start Marketing Date : 2020-12-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0002
Start Marketing Date : 2019-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Zileuton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Zileuton, including repackagers and relabelers. The FDA regulates Zileuton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Zileuton 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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A Zileuton supplier is an individual or a company that provides Zileuton active pharmaceutical ingredient (API) or Zileuton finished formulations upon request. The Zileuton suppliers may include Zileuton API manufacturers, exporters, distributors and traders.
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