Molecules / Dapsone

Dapsone API manufacturers

CAS 80-08-0 ATC D10AX05 Updated 9 July 2026
12
manufacturers with an active filing 11 of them hold a US DMF or a CEP
$767.08
median export price per kg $364.31 to $926.54 · 10 exporters · 2025
4
shortage records on file across 1 countries
98
finished-dose makers across 30 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Cohance Lifesciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs and one valid CEP for dapsone, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

Macleods Pharmaceuticals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dapsone, filing since 2019. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Novitium Pharma

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dapsone, filing since 2013. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 4 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Nuray Chemicals

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for dapsone, filing since 2025. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
07

Sai Life Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dapsone, filing since 2013. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Atul

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dapsone, filing since 2004.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Dipharma Francis

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dapsone, filing since 2017. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Lundbeck Pharmaceuticals Italy

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dapsone, filing since 2000. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Medisun Health Care

India
Makes the API

Registered with DAV (Vietnam) for dapsone. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

9 more manufacturers hold filings for dapsone

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Macleods PharmaceuticalsNovitium PharmaNuray ChemicalsSai Life SciencesAtulDipharma FrancisLundbeck Pharmaceuticals ItalyChongqing Huapont PharmaceuticalMedisun Health Care
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Contract manufacturers (3)

Dipharma Francis Italy Sai Life Sciences India Lundbeck Pharmaceuticals Italy Italy

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (25)

Abbvie United States Encube Ethicals India Amneal United States Viatris United States Alembic Pharmaceuticals India Teva Israel Zentiva, k.s Czech Republic ANI Pharmaceuticals United States Tiofarma Netherlands Sanofi Winthrop Industrie France Amneal Pharmaceuticals NY United States Chartwell RX United States Cosette Pharmaceuticals United States Padagis Israel Israel Pharmaniaga Manufacturing Berhad Malaysia Swiss Caps Switzerland Esteve Pharmaceuticals Spain Aurobindo Pharma India Ems S/A Brazil Marcyrl Pharmaceutical Industries Egypt

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

Who makes dapsone?

Ask Fred which manufacturers are on record for dapsone and what filings they hold.

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Also on this molecule

Price history 4 yrs Shortages 4 Recalls 4 Finished dose 25 Contract mfrs 3

By country

India 7

Export price by year

Year Median Exporters
2025 $767.08 10
2024 $682.90 13
2023 $765.00 9
2022 $748.57 6

US dollars per kilogram, customs export unit values.