Molecules / Paracetamol

Paracetamol API manufacturers

Also known as acetaminophen CAS 103-90-2 ATC N02BE01 INN acetaminophen Updated 9 July 2026
60
manufacturers with an active filing 14 of them hold a US DMF or a CEP
$4.30
median export price per kg $3.32 to $5.44 · 122 exporters · 2025
89
shortage records on file across 3 countries
4,721
finished-dose makers across 55 regulators
Showing 20 of 60 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Granules India

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

Holds 2 active US DMFs for paracetamol, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
7 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Specgx

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

Holds 3 active US DMFs for paracetamol, filing since 1984. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
06

Adare Pharmaceuticals

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

Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

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

: Zhejiang Kangle Pharmaceutical

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

Holds 2 active US DMFs for paracetamol, filing since 2002. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Hebei Jiheng Pharmaceutical

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

Holds one active US DMF for paracetamol, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Apitoria Pharma

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

Holds one active US DMF for paracetamol, 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
11

Atabay Kimya Sanayi Ve Ticaret

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

Holds one active US DMF for paracetamol, filing since 1986. Its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Shenzhou Jiheng Pharmaceutical

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

Holds one active US DMF for paracetamol, filing since 2012. 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
15

Mallinckrodt

Ireland
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for paracetamol. Its GMP is recognised in 12 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
12 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Imexpharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for paracetamol. 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
17

Lianyungang Kangle Pharmaceutical

China
Makes the API

Registered with SFDA (Saudi Arabia) for paracetamol. Its 2025 FDA inspection closed as VAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18

Agimexpharm Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for paracetamol. 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
19

Công Ty Cổ Phần Dược Phẩm Tv.Pharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for paracetamol. 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
20

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for paracetamol. 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

57 more manufacturers hold filings for paracetamol

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

IOL Chemicals and PharmaceuticalsMeghmaniAdare Pharmaceuticals: Zhejiang Kangle PharmaceuticalFarmson Basic DrugsHebei Jiheng PharmaceuticalApitoria PharmaAtabay Kimya Sanayi Ve TicaretShenzhou Jiheng PharmaceuticalHebei Jiheng Group PharmaceuticalAnqui Lu'an Pharmaceutical Co.,LtdMallinckrodtImexpharmLianyungang Kangle PharmaceuticalAgimexpharm PharmaceuticalCông Ty Cổ Phần Dược Phẩm Tv.PharmCông ty Cổ phần Dược phẩm CPC1 Hà Nội
Open the full list with a free account

Contract manufacturers (8)

Granules India India Anqiu Lu'an Pharmaceutical China Finecure pharmaceuticals India Merit Organics India Olive Healthcare India Hebei Jiheng Pharmaceutical China Contract Pharmacal United States Atabay Ki̇mya Sanayi̇ Ti̇caret A.Ş Turkey

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

Finished-dose makers (369)

Fresenius Kabi Ab Sweden Viatris United States Glenmark Pharmaceuticals s.r.o Czech Republic Caplin Steriles India Dr. Reddy's Laboratories India Vovantis Laboratories India Amneal United States HIKMA ITALIA Italy Teva Israel Bristol-Myers Squibb United States unique pharmaceutical laboratories India Haleon Ireland Dungarvan Ireland Otsuka Pharmaceutical India India Zentiva, k.s Czech Republic «B. Braun Medical» Portugal Gilead Sciences United States Pharmascience Canada Reckitt Benckiser healthcare (UK) United Kingdom Sanofi France Allegiant Health United States

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.

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Also on this molecule

Price history 4 yrs Shortages 89 Recalls 140 Finished dose 369 Contract mfrs 8

By country

China 13 India 9

Export price by year

Year Median Exporters
2026 YTD $3.89 39
2025 $4.30 122
2024 $4.95 124
2023 $7.36 202

US dollars per kilogram, customs export unit values.