Molecules / Efinaconazole

Efinaconazole API manufacturers

CAS 164650-44-6 ATC D01AC19 Updated 9 July 2026
16
manufacturers with an active filing 16 of them hold a US DMF or a CEP
20
finished-dose makers across 8 regulators
Showing 16 of 16 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Lupin

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

Holds one active US DMF for efinaconazole, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Macleods Pharmaceuticals

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

Holds one active US DMF for efinaconazole, filing since 2018. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Harman Finochem

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

Holds one active US DMF for efinaconazole, filing since 2017. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.

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

Cipla

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

Holds one active US DMF for efinaconazole, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Alivus Life Sciences

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

Holds 2 active US DMFs for efinaconazole, filing since 2016. 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
View profile
06

KAKEN Pharmaceutical

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

Holds one active US DMF for efinaconazole, filing since 2013. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Viwit Pharmaceutical

China
Makes the API

Holds one active US DMF for efinaconazole, filing since 2022. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Wavelength Enterprises

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

Holds 4 active US DMFs for efinaconazole, filing since 2016. 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
View profile
09

Solara Active Pharma Sciences

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

Holds one active US DMF for efinaconazole, filing since 2017. 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
10

Maithri Drugs

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

Holds one active US DMF for efinaconazole, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Virupaksha Organics

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

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

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Shenzhen Haibin Pharmaceutical

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

Holds one active US DMF for efinaconazole, filing since 2024. Its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Topharman Shandong

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

Holds one active US DMF for efinaconazole, filing since 2018. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Dipharma Francis

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

Holds one active US DMF for efinaconazole, filing since 2017. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Matrix Pharmacorp

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

Holds one active US DMF for efinaconazole, filing since 2019. 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
16

PROCOS

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

Holds one active US DMF for efinaconazole, filing since 2017. Its 2022 FDA inspection closed as VAI.

US DMF
1 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

13 more manufacturers hold filings for efinaconazole

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

CiplaAlivus Life SciencesKAKEN PharmaceuticalViwit PharmaceuticalWavelength EnterprisesSolara Active Pharma SciencesMaithri DrugsVirupaksha OrganicsShenzhen Haibin PharmaceuticalTopharman ShandongDipharma FrancisMatrix PharmacorpPROCOS
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Contract manufacturers (5)

Dipharma Francis Italy PROCOS Italy Viwit Pharmaceutical China Metrochem API India Olon Italy

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

Finished-dose makers (6)

Bausch Health Companies Canada Teva Israel Alembic Pharmaceuticals India Zydus Lifesciences India Padagis Us United States Dr. LAZAR y Cia. S.A.Q. e I Argentina

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 efinaconazole?

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

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Also on this molecule

Finished dose 6 Contract mfrs 5

By country

India 9