Molecules / Phenylephrine

Phenylephrine API manufacturers

CAS 59-42-7 ATC C01CA06 Updated 9 July 2026
23
manufacturers with an active filing 12 of them hold a US DMF or a CEP
$172.25
median export price per kg $96.24 to $206.75 · 20 exporters · 2025
46
shortage records on file across 4 countries
661
finished-dose makers across 46 regulators
Showing 20 of 23 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Divi's Laboratories

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

Holds one valid CEP for phenylephrine, filing since 2021. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
2 markets
How this listing is sourced EDQM certificate database
View profile
03

Malladi Drugs & Pharmaceuticals

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

Holds 2 active US DMFs for phenylephrine, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Unichem Laboratories

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

Holds one valid CEP for phenylephrine, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2026 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
View profile
05

Shilpa Pharma Lifesciences

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

Holds one active US DMF for phenylephrine, filing since 2021. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Boehringer Ingelheim Pharma Gmbh

Germany
Makes the API

Registered with SFDA (Saudi Arabia) for phenylephrine. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
42 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
07

Spera Nexus

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

Holds one active US DMF for phenylephrine, filing since 1989. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Aarti Pharmalabs

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

Holds one active US DMF for phenylephrine, filing since 2025. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Cheng Fong Chemical

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

Holds 2 active US DMFs for phenylephrine, filing since 2005. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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

Registered with SFDA (Saudi Arabia) for phenylephrine. Its 2025 FDA inspection closed as NAI.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
11

Syn-Tech Chem. & Pharm

Taiwan
Makes the API

Holds one active US DMF for phenylephrine, filing since 2005. 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
12

Wuhan Wuyao Pharmaceutical

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

Holds one valid CEP for phenylephrine, filing since 2026. 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
13

Divi'S Labotatories

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

Holds one active US DMF for phenylephrine, filing since 2003.

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
15

Imexpharm

Vietnam
Makes the API

Registered with DAV (Vietnam) for phenylephrine. 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
16

Mediplantex

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for phenylephrine. 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

Mekophar Chemical Pharmaceutical

Vietnam
Makes the API

Registered with DAV (Vietnam) for phenylephrine. Its GMP is recognised in 2 markets.

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

Registered with DAV (Vietnam) for phenylephrine. 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

Registered with DAV (Vietnam) for phenylephrine. 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

Vacopharm Pharmaceutical Joint Stock

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for phenylephrine. 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 more manufacturers hold filings for phenylephrine

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

Unichem LaboratoriesShilpa Pharma LifesciencesBoehringer Ingelheim Pharma GmbhSpera NexusAarti PharmalabsCheng Fong ChemicalZhejiang Hisoar Chuannan PharmaceuticalSyn-Tech Chem. & PharmWuhan Wuyao PharmaceuticalDivi'S LabotatoriesZhejiang Boxiao BiopharmaceuticalImexpharmMediplantexMekophar Chemical PharmaceuticalCông ty cổ phần dược phẩm Boston Việt NamCông ty cổ phần dược phẩm SaViVacopharm Pharmaceutical Joint Stock
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Contract manufacturers (8)

Granules India India Divi's Laboratories India Chemische Fabrik Berg Germany Olive Healthcare India Contract Pharmacal United States Shenzhen Oriental Pharmaceutical China Malladi Drugs And Pharmaceuticals India Surya Life Sciences India

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

Finished-dose makers (116)

Dr. Reddy's Laboratories India Amneal United States Caplin Steriles India Fresenius Kabi Ab Sweden Alcon Research United States Gilead Sciences United States Genus Lifesciences United States Gland Pharma India Sandoz Switzerland Sintetica Switzerland Hainan Poly Pharm China Abbvie United States Bausch & Lomb United States FDC India Glenmark Pharmaceuticals s.r.o Czech Republic HIKMA ITALIA Italy Procter & Gamble United States SmartPractice Denmark ApS Denmark Reckitt Benckiser healthcare (UK) United Kingdom Allergan Produtos Farmaceuticos Ltda Brazil

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 phenylephrine?

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

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Also on this molecule

Price history 4 yrs Shortages 46 Recalls 137 Finished dose 116 Contract mfrs 8

By country

India 6

Sold in these combinations

Phenylephrine + Acetaminophen 2 APIs Phenylephrine + Ibuprofen 2 APIs Chlorpheniramine + Phenylephrine + Acetaminophen 3 APIs Guaifenesin + Phenylephrine + Acetaminophen 3 APIs Phenylephrine + Acetaminophen + Caffeine 3 APIs

Fixed-dose combinations containing phenylephrine. Each page leads with the verified API makers of every component.

Export price by year

Year Median Exporters
2025 $172.25 20
2024 $147.50 19
2023 $179.11 17
2022 $174.42 26

US dollars per kilogram, customs export unit values.