Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
01 1FARMAK, a.s
02 1Biophore India Pharmaceuticals Pvt Ltd
03 1Transo-Pharm USA LLC
04 1USV Private Limited
05 1Anax Laboratories
06 1BrightGene Bio-Medical Technology Co.,Ltd
07 1Curia
08 2GLAND PHARMA LIMITED
09 1Hetero Drugs
10 1MSN Laboratories
11 1Nanjing Heron Pharmaceutical
12 1SKVen Technologies Pvt. Ltd
13 1ScinoPharm Taiwan, Ltd
14 1Sionc Pharmaceuticals
15 1Sun Pharmaceutical Industries Limited
16 1Viatris
17 1Wockhardt
18 1Zhuhai Rundu Pharmaceutical
01 3China
02 1Czech Republic
03 11India
04 1Taiwan
05 3U.S.A
01 12Active
02 7Blank
01 19Blank
01 19Blank
01 1WC-0273
02 1WC-0427
03 17Blank
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-02-18
Pay. Date : 2021-01-13
DMF Number : 35433
Submission : 2021-01-04
Status : Active
Type : II
NDC Package Code : 63278-1068
Start Marketing Date : 2010-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-12-08
Pay. Date : 2016-09-16
DMF Number : 30834
Submission : 2016-09-13
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-24
Pay. Date : 2015-06-24
DMF Number : 29315
Submission : 2015-06-23
Status : Active
Type : II
NDC Package Code : 62147-0220
Start Marketing Date : 2019-12-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-16
Pay. Date : 2015-08-27
DMF Number : 28939
Submission : 2014-12-25
Status : Active
Type : II
NDC Package Code : 65129-1331
Start Marketing Date : 2015-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-04
Pay. Date : 2018-09-14
DMF Number : 32339
Submission : 2018-01-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-09-30
Pay. Date : 2015-03-31
DMF Number : 29185
Submission : 2015-03-31
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-15
Pay. Date : 2014-02-27
DMF Number : 27972
Submission : 2014-02-12
Status : Active
Type : II
Date of Issue : 2019-03-05
Valid Till : 2022-03-04
Written Confirmation Number : WC-0427
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-08-29
Pay. Date : 2022-08-10
DMF Number : 37226
Submission : 2022-06-24
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-12-08
Pay. Date : 2017-03-27
DMF Number : 31539
Submission : 2017-11-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36679
Submission : 2022-01-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36338
Submission : 2021-11-26
Status : Active
Type : II
NDC Package Code : 69766-103
Start Marketing Date : 2021-11-24
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-05-24
Pay. Date : 2016-09-20
DMF Number : 30542
Submission : 2016-05-10
Status : Active
Type : II
NDC Package Code : 17180-0203
Start Marketing Date : 2008-04-10
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100g/100g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Date of Issue : 2020-07-23
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273
Address of the Firm :
NDC Package Code : 76055-0024
Start Marketing Date : 2019-12-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Regadenoson manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Regadenoson, including repackagers and relabelers. The FDA regulates Regadenoson manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Regadenoson API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Regadenoson manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Regadenoson supplier is an individual or a company that provides Regadenoson active pharmaceutical ingredient (API) or Regadenoson finished formulations upon request. The Regadenoson suppliers may include Regadenoson API manufacturers, exporters, distributors and traders.
click here to find a list of Regadenoson suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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