Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
02 1Cohance Lifesciences
03 1HRV Global Life Sciences
04 1Atul Limited
05 1Chongqing Huapont Pharmaceutical
06 1Dipharma
07 1Extrovis AG
08 1Fleming Laboratories
09 1Guangzhou Tosun Pharmaceutical
10 1H. Lundbeck AS
11 1Jacobus Pharmaceutical Company, Inc
12 2Macleods Pharmaceuticals Limited
13 2Medilux Laboratories
14 1Regis Technologies
15 1Sai Life Sciences Limited
16 1Sms Lifesciences
17 1Taro Pharmaceutical Industries
01 2China
02 1Denmark
03 11India
04 1Italy
05 1Switzerland
06 3U.S.A
01 12Active
02 3Inactive
03 4Blank
01 3Valid
02 16Blank
01 19Blank
01 1WC-0130
02 1WC-0181
03 1WC-0195
04 1WC-0381
05 1WC-0381n
06 1WC-0416
07 13Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-16
Pay. Date : 2013-12-13
DMF Number : 27678
Submission : 2013-12-13
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-033
Start Marketing Date : 2024-12-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35342
Submission : 2020-10-30
Status : Active
Type : II
Certificate Number : CEP 2020-358 - Rev 01
Issue Date : 2024-07-10
Type : Chemical
Substance Number : 77
Status : Valid
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm :
NDC Package Code : 76072-1018
Start Marketing Date : 2019-07-01
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 : 15065
Submission : 2000-09-29
Status : Active
Type : II
NDC Package Code : 45562-1120
Start Marketing Date : 2001-03-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38483
Submission : 2023-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38378
Submission : 2023-06-05
Status : Active
Type : II
Date of Issue : 2020-08-17
Valid Till : 2023-08-23
Written Confirmation Number : WC-0381
Address of the Firm :
NDC Package Code : 50218-008
Start Marketing Date : 2019-03-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-30
Pay. Date : 2014-01-16
DMF Number : 27701
Submission : 2013-11-06
Status : Active
Type : II
Date of Issue : 2022-07-26
Valid Till : 2025-07-14
Written Confirmation Number : WC-0130
Address of the Firm :
NDC Package Code : 14474-026
Start Marketing Date : 2012-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-04
Pay. Date : 2019-10-30
DMF Number : 31521
Submission : 2017-06-22
Status : Active
Type : II
NDC Package Code : 46438-0645
Start Marketing Date : 2018-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-04-20
Pay. Date : 2016-03-29
DMF Number : 29999
Submission : 2016-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33630
Submission : 2019-03-09
Status : Active
Type : II
Certificate Number : CEP 2022-379 - Rev 00
Issue Date : 2024-06-12
Type : Chemical
Substance Number : 77
Status : Valid
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-08-12
Pay. Date : 2013-02-26
DMF Number : 17781
Submission : 2004-10-28
Status : Active
Type : II
Certificate Number : R1-CEP 2015-177 - Rev 00
Issue Date : 2022-03-21
Type : Chemical
Substance Number : 77
Status : Valid
NDC Package Code : 53596-014
Start Marketing Date : 2012-12-20
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33228
Submission : 2019-01-16
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-03-29
Pay. Date : 2022-03-21
DMF Number : 35244
Submission : 2021-12-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35786
Submission : 2022-02-19
Status : Inactive
Type : II
Date of Issue : 2020-08-17
Valid Till : 2023-08-23
Written Confirmation Number : WC-0381n
Address of the Firm :
NDC Package Code : 50218-008
Start Marketing Date : 2019-03-19
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 : 7413
Submission : 1988-03-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25089
Submission : 2011-06-29
Status : Inactive
Type : II
Date of Issue : 2022-09-07
Valid Till : 2025-09-09
Written Confirmation Number : WC-0181
Address of the Firm :
NDC Package Code : 72375-0006
Start Marketing Date : 2021-09-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
A Dapsone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dapsone, including repackagers and relabelers. The FDA regulates Dapsone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dapsone 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 Dapsone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dapsone supplier is an individual or a company that provides Dapsone active pharmaceutical ingredient (API) or Dapsone finished formulations upon request. The Dapsone suppliers may include Dapsone API manufacturers, exporters, distributors and traders.
click here to find a list of Dapsone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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