Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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01 1Nuray Chemicals Private Limited
02 1Lundbeck CDM
03 1HRV Pharma
04 1Willow Birch Pharma
05 1Atul Bioscience Ltd
06 1Ax Pharmaceutical Corporation
07 1Chongqing Huapont Pharmaceutical
08 1Darmerica
09 2Dipharma
10 1Extrovis AG
11 1Fagron Group
12 1Fleming Laboratories
13 1Guangzhou Tosun Pharmaceutical
14 1Jacobus Pharmaceutical Company, Inc
15 1Letco Medical
16 2Macleods Pharmaceuticals Limited
17 2Medilux Laboratories
18 3Pcca
19 1Regis Technologies
20 2Sai Life Sciences Limited
21 1Sms Lifesciences
22 1Spectrum Chemical
23 1Taro Pharmaceutical Industries
24 3Blank
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01 1Canada
02 2China
03 11India
04 3Italy
05 1Netherlands
06 1Switzerland
07 7U.S.A
08 3United Kingdom
09 3Blank
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01 11Active
02 3Inactive
03 18Blank
01 4Valid
02 28Blank
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01 1307MF10152
02 31Blank
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01 2WC-0130
02 1WC-0181
03 1WC-0381
04 1WC-0416
05 27Blank
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01 32Blank
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01 114474-026
02 145562-1120
03 146438-0645
04 146438-0649
05 149452-2439
06 150218-008
07 151552-1042
08 151927-0083
09 151927-0084
10 151927-0085
11 153596-014
12 162991-3187
13 171052-100
14 172375-0006
15 173377-249
16 183511-022
17 16Blank
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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
Certificate Number : CEP 2023-396 - Rev 00
Issue Date : 2025-09-10
Type : Chemical
Substance Number : 77
Status : Valid
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
Lundbeck CDM has decades of experience in development and production services related to APIs and custom manufacturing services.
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
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 : 2025-08-05
Valid Till : 2028-07-14
Written Confirmation Number : WC-0130
Address of the Firm :
NDC Package Code : 14474-026
Start Marketing Date : 2012-10-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT

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

✕ Product Not Available For Sales
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 : N/A
Rev. Date :
Pay. Date :
DMF Number : 25089
Submission : 2011-06-29
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35786
Submission : 2022-02-19
Status : Inactive
Type : II
Certificate Number : CEP 2023-195 - Rev 00
Issue Date : 2025-06-03
Type : Chemical
Substance Number : 77
Status : Valid
Date of Issue : 2023-07-24
Valid Till : 2026-08-23
Written Confirmation Number : WC-0381
Address of the Firm :
NDC Package Code : 50218-008
Start Marketing Date : 2019-03-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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A ICI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ICI, including repackagers and relabelers. The FDA regulates ICI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ICI 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 ICI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ICI supplier is an individual or a company that provides ICI active pharmaceutical ingredient (API) or ICI finished formulations upon request. The ICI suppliers may include ICI API manufacturers, exporters, distributors and traders.
click here to find a list of ICI suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
We have 23 companies offering ICI
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