Molecules / Terbinafine

Terbinafine API manufacturers

CAS 91161-71-6 ATC D01AE15 · Topical antifungals Updated 9 July 2026
28
manufacturers with an active filing 20 of them hold a US DMF or a CEP
$135.00
median export price per kg $55.88 to $177.13 · 33 exporters · 2025
75
shortage records on file across 6 countries
838
finished-dose makers across 49 regulators
Showing 20 of 28 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

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 terbinafine, filing since 2005. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

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

Dr. Reddy's Laboratories

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 terbinafine, filing since 2002. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
03

MSN Laboratories

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

Holds one active US DMF and one valid CEP for terbinafine, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
05

Cipla

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

Holds one active US DMF and 4 valid CEPs for terbinafine, filing since 2004. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

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

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 terbinafine, filing since 2005. 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
08

Novartis

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

Holds one active US DMF for terbinafine, filing since 2013. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 35 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
35 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

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 terbinafine, filing since 2005. 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
11

Orbion Pharmaceuticals

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

Holds one active US DMF for terbinafine, filing since 2005.

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
12

Quimica Sintetica

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

Holds one active US DMF for terbinafine, filing since 2004. Its 2023 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Amino Chemicals

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

Holds one active US DMF for terbinafine, filing since 2002. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 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
14

Synergene Active Ingredients

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

Holds one active US DMF for terbinafine, filing since 2023. 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
15

Tianjin Weijie Pharmaceutical

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

Holds one active US DMF for terbinafine, filing since 2016. 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
16

Zhejiang East-Asia Pharmaceutical

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

Holds one valid CEP for terbinafine, filing since 2018. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
View profile
17

Chromo Laboratories India

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

Holds 2 active US DMFs for terbinafine, filing since 2017. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Chr. Olesen Synthesis A/S

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

Holds one valid CEP for terbinafine, filing since 2019. Its 2023 FDA inspection closed as VAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
19

Saptagir Laboratories

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

Holds 2 active US DMFs for terbinafine, filing since 2022.

US DMF
2 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
20

Shandong Boyuan Pharmaceutical

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

Holds one valid CEP for terbinafine, filing since 2025.

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

Contract manufacturers (4)

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 $135.00 33
2024 $110.49 37
2023 $113.11 51
2022 $140.25 30

US dollars per kilogram, customs export unit values.