Molecules / Teriflunomide

Teriflunomide API manufacturers

CAS 163451-81-8 ATC L04AA31 Updated 9 July 2026
23
manufacturers with an active filing 20 of them hold a US DMF or a CEP
$3432.54
median export price per kg $2628.13 to $4181.29 · 10 exporters · 2025
19
shortage records on file across 3 countries
502
finished-dose makers across 33 regulators
Showing 20 of 23 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

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 teriflunomide, filing since 2016. 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
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

MSN 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 teriflunomide, filing since 2014. 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
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
03

Biocon

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 teriflunomide, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
04

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 teriflunomide, 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
How this listing is sourced EDQM certificate database
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 and one valid CEP for teriflunomide, filing since 2015. 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
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
07

PharmaZell

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

Holds one active US DMF and one valid CEP for teriflunomide, filing since 2016. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
08

Unichem Laboratories

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

Holds one valid CEP for teriflunomide, filing since 2024. 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
09

Natco Pharma

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

Holds 2 active US DMFs for teriflunomide, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 15 markets.

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

Zydus Lifesciences

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

Holds one active US DMF for teriflunomide, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Formosa Laboratories

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

Holds one active US DMF for teriflunomide, filing since 2015. 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
12

Raks Pharma

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

Holds one active US DMF for teriflunomide, filing since 2015. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Olon

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

Holds one active US DMF for teriflunomide, filing since 2016. 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
14

Megafine Pharma (P)

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

Holds one active US DMF for teriflunomide, filing since 2015. 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
15

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 teriflunomide, filing since 2016. 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
16

Maprimed

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

Holds one active US DMF for teriflunomide, filing since 2021. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Sanofi

France
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for teriflunomide. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 40 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
40 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
18

Optimus Drugs

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

Holds one active US DMF for teriflunomide, filing since 2021. 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
19

Tianjin Weijie Pharmaceutical

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

Holds one active US DMF for teriflunomide, 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
20

Mega Fine Pharma

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

Holds one valid CEP for teriflunomide, filing since 2024.

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

20 more manufacturers hold filings for teriflunomide

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

Honour LabAlivus Life SciencesShilpa Pharma LifesciencesPharmaZellUnichem LaboratoriesNatco PharmaZydus LifesciencesFormosa LaboratoriesRaks PharmaOlonMegafine Pharma (P)Apitoria PharmaMaprimedSanofiOptimus DrugsTianjin Weijie PharmaceuticalMega Fine Pharma
Open the full list with a free account

Finished-dose makers (36)

Glenmark Pharmaceuticals s.r.o Czech Republic Viatris United States Genzyme United States Concord Biotech India Pharmascience Canada Zentiva, k.s Czech Republic Apotex Canada Sanofi Winthrop Industrie France Dr. Reddy's Laboratories India Hetero India Teva Israel Torrent Pharmaceuticals India Sandoz Switzerland Mylan Pharmaceuticals United States Opella Healthcare Brazil Ltda Brazil Pharmathen Greece Aizant Drug Research Solutions India Jamp Pharma Canada Laboratorios Basi Industria Farmaceutica S A Portugal Orion Finland

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.

Map teriflunomide for your markets

Tell us which markets you need to file in. These suppliers come back tiered for those markets, with the price corridor and an RFI sheet.

Start for free
No sales call.

Also on this molecule

Price history 1 yrs Shortages 19 Recalls 2 Finished dose 36 Contract mfrs 0

By country

India 25