Molecules / Amiodarone

Amiodarone API manufacturers

CAS 1951-25-3 ATC C01BD01 Updated 9 July 2026
12
manufacturers with an active filing 10 of them hold a US DMF or a CEP
$160.00
median export price per kg $145.37 to $177.00 · 9 exporters · 2025
68
shortage records on file across 8 countries
416
finished-dose makers across 47 regulators
Showing 12 of 12 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Piramal Pharma

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

Holds one active US DMF and one valid CEP for amiodarone, filing since 2008. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

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

Alivus Life Sciences

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

Holds 2 active US DMFs and one valid CEP for amiodarone, filing since 2003. 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
04

Sanofi Winthrop Industrie

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

Holds one valid CEP for amiodarone, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 17 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
17 markets
How this listing is sourced EDQM certificate database
View profile
05

Hainan Poly Pharm

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

Holds one active US DMF for amiodarone, filing since 2021. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Zhejiang Hengkang Pharmaceutical

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

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

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
07

CTX 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 amiodarone, filing since 2025. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
08

PMC Isochem

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

Holds 3 active US DMFs for amiodarone, filing since 1988. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
3 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Arevipharma

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

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

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
10

Olon

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

Holds one valid CEP for amiodarone, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
View profile
11

Registered with DAV (Vietnam) for amiodarone. 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

Registered with DAV (Vietnam) for amiodarone. 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 amiodarone

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

Open the full list with a free account

Contract manufacturers (5)

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.

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Export price by year

Year Median Exporters
2025 $160.00 9
2024 $165.00 12
2023 $169.00 8
2022 $177.75 8

US dollars per kilogram, customs export unit values.