Molecules / Dexamethasone

Dexamethasone API manufacturers

CAS 50-02-2 ATC A01AC02 · Oral corticosteroids for local treatment Updated 9 July 2026
27
manufacturers with an active filing 12 of them hold a US DMF or a CEP
$610.00
median export price per kg $475.00 to $1000.00 · 50 exporters · 2025
120
shortage records on file across 8 countries
1,870
finished-dose makers across 52 regulators
Showing 20 of 27 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

02

Curia Spain S.A.U

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

Holds one active US DMF for dexamethasone, filing since 2015. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
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04

Fresenius Kabi Ab

Sweden
Makes the APIFinished dose

Registered with DAV (Vietnam) for dexamethasone. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 48 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
48 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
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05

Henan Lihua Pharmaceutical

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

Holds one active US DMF for dexamethasone, filing since 2024. Its 2021 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2021 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
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07

Symbiotec Pharmalab

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

Holds 2 active US DMFs for dexamethasone, filing since 2023. Its 2022 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Tianjin Tianyao Pharmaceuticals

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

Holds 3 active US DMFs for dexamethasone, filing since 2004. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
3 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

Farmabios

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

Holds 2 active US DMFs for dexamethasone, filing since 2017. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Mahima Life Sciences

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

Holds one active US DMF for dexamethasone, filing since 2013.

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
14

Crystal Pharma, S.A.U

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for dexamethasone. 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
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15

Công ty Cổ phần Dược phẩm CPC1 Hà Nội

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for dexamethasone. 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

Roussel

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for dexamethasone. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Vacopharm Pharmaceutical Joint Stock

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for dexamethasone. 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
18

Cty Tnhh Dược Phẩm Usa-Nic

Vietnam
Makes the API

Registered with DAV (Vietnam) for dexamethasone.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
19

Great Pacific Exports

India
Makes the API

Registered with SFDA (Saudi Arabia) for dexamethasone.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
20

Meyer Bpc Joint Venture

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for dexamethasone. 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

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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Export price by year

Year Median Exporters
2026 YTD $447.00 14
2025 $610.00 50
2024 $625.00 44
2023 $750.00 36

US dollars per kilogram, customs export unit values.