Molecules / Hydroxychloroquine

Hydroxychloroquine API manufacturers

CAS 118-42-3 ATC P01BA02 Updated 9 July 2026
18
manufacturers with an active filing 18 of them hold a US DMF or a CEP
$128.94
median export price per kg $87.36 to $161.19 · 18 exporters · 2025
9
shortage records on file across 3 countries
198
finished-dose makers across 37 regulators
Showing 18 of 18 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Ipca Laboratories

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

Holds one active US DMF and 2 valid CEPs for hydroxychloroquine, filing since 1999. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
19 markets
02

Zydus Lifesciences

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

Holds one active US DMF and one valid CEP for hydroxychloroquine, filing since 2000. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
03

Laurus Labs

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

Holds 2 active US DMFs and one valid CEP for hydroxychloroquine, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
04

MSN Laboratories

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

Holds one active US DMF and one valid CEP for hydroxychloroquine, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
05

Symed Labs

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

Holds 2 active US DMFs and one valid CEP for hydroxychloroquine, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
06

Dr. Reddy's Laboratories

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

Holds one active US DMF for hydroxychloroquine, filing since 2021. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Fermion Oy

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

Holds one active US DMF and one valid CEP for hydroxychloroquine, filing since 2015. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
09

Srini Pharmaceuticals

India
Makes the API

Holds one active US DMF for hydroxychloroquine, filing since 2020. Its 2019 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Chongqing Kangle Pharmaceutical

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

Holds one active US DMF for hydroxychloroquine, filing since 2016. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

EUROAPI

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

Holds one active US DMF for hydroxychloroquine, filing since 2007. Its 2019 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Porton Pharma Solutions

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

Holds one valid CEP for hydroxychloroquine, filing since 2025. Its 2024 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
13

Sci Pharmtech

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

Holds one active US DMF for hydroxychloroquine, filing since 1990. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Wuhan Wuyao Pharmaceutical

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

Holds one valid CEP for hydroxychloroquine, filing since 2025. Its 2025 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
15

Zhejiang Supor Pharmaceuticals

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

Holds one active US DMF for hydroxychloroquine, filing since 2022. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Alkaloida Chemical

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

Holds one active US DMF for hydroxychloroquine, filing since 2010.

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
18

SMS Pharmaceuticals

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

Holds one active US DMF for hydroxychloroquine, filing since 2022. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

Contract manufacturers (1)

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

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.

Map hydroxychloroquine for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Export price by year

Year Median Exporters
2025 $128.94 18
2024 $89.07 18
2023 $112.94 25
2022 $140.00 20

US dollars per kilogram, customs export unit values.