Molecules / Tadalafil

Tadalafil API manufacturers

CAS 171596-29-5 ATC G04BE08 Updated 9 July 2026
39
manufacturers with an active filing 25 of them hold a US DMF or a CEP
$405.11
median export price per kg $225.00 to $800.00 · 95 exporters · 2025
298
shortage records on file across 12 countries
1,418
finished-dose makers across 54 regulators
Showing 20 of 39 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Macleods Pharmaceuticals

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 tadalafil, filing since 2013. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
02

Alembic Pharmaceuticals

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 tadalafil, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

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

Ami Lifesciences

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

Holds one active US DMF and one valid CEP for tadalafil, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2024 · VAI
GMP recognised in
2 markets
04

Alivus Life Sciences

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

Holds 4 active US DMFs and one valid CEP for tadalafil, filing since 2009. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

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

Honour Lab

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

Holds one active US DMF and one valid CEP for tadalafil, filing since 2015. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
09

Apotex

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

Holds one active US DMF for tadalafil, filing since 2012. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Shandong New Time Pharmaceutical

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

Holds one active US DMF for tadalafil, filing since 2023. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
6 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Unichem Laboratories

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

Holds one valid CEP for tadalafil, filing since 2025. 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
12

Ruyuan Hec Pharm

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

Holds one active US DMF for tadalafil, filing since 2018. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Amoli Organics

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

Holds one active US DMF for tadalafil, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Orchid Pharma

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

Holds one active US DMF for tadalafil, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Zaklady Farmaceutyczne Polpharma

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

Holds one active US DMF for tadalafil, filing since 2011. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Dr. Reddy's Laboratories

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for tadalafil. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

SMS Pharmaceuticals

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

Holds one active US DMF and one valid CEP for tadalafil, filing since 2010. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · OAI
GMP recognised in
6 markets
18

Apitoria 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 tadalafil, filing since 2012. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
20

Azico Biophore India

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

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

US DMF
1 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
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 $369.62 33
2025 $405.11 95
2024 $455.90 72
2023 $500.00 65

US dollars per kilogram, customs export unit values.