Molecules / Tavaborole

Tavaborole API manufacturers

CAS 174671-46-6 ATC D01AE24 · Topical antifungals Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
10
finished-dose makers across 1 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF for tavaborole, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Alivus Life Sciences

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

Holds 2 active US DMFs for tavaborole, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 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
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03

Wavelength Enterprises

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

Holds 4 active US DMFs for tavaborole, filing since 2017. Its 2022 FDA inspection closed as NAI.

US DMF
4 active
CEP
None on file
Last FDA inspection
2022 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
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04

Biophore India Pharmaceuticals

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

Holds one active US DMF for tavaborole, filing since 2017. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Honour Lab

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

Holds one active US DMF for tavaborole, filing since 2018. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile

2 more manufacturers hold filings for tavaborole

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

Biophore India PharmaceuticalsHonour Lab
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Finished-dose makers (7)

Encube Ethicals India Alembic Pharmaceuticals India Cipla India Amneal United States Chartwell RX United States Lupin India Padagis Us 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

Who makes tavaborole?

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

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Also on this molecule

Recalls 2 Finished dose 7 Contract mfrs 0