Molecules / Vortioxetine

Vortioxetine API manufacturers

CAS 508233-74-7 ATC N06AX26 · Other antidepressants Updated 9 July 2026
20
manufacturers with an active filing 20 of them hold a US DMF or a CEP
$3000.00
median export price per kg $2300.00 to $3600.00 · 13 exporters · 2025
5
shortage records on file across 2 countries
229
finished-dose makers across 40 regulators
Showing 20 of 20 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 for vortioxetine, filing since 2017. 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
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02

Lupin

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

Holds one active US DMF for vortioxetine, 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
03

Macleods Pharmaceuticals

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

Holds one active US DMF for vortioxetine, filing since 2017. 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
04

Alembic Pharmaceuticals

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

Holds one active US DMF for vortioxetine, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 18 markets.

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

Piramal Pharma

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

Holds one active US DMF for vortioxetine, filing since 2021. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Lek Pharmaceuticals D.D

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

Holds one active US DMF for vortioxetine, filing since 2017. Its GMP is recognised in 13 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Cipla

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

Holds one active US DMF for vortioxetine, filing since 2017. 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
08

Zydus Lifesciences

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

Holds 2 active US DMFs for vortioxetine, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

US DMF
2 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
09

Raks Pharma

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

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

Symed Labs

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

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

US DMF
2 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
11

Morepen Laboratories

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

Holds 2 active US DMFs for vortioxetine, filing since 2022. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

MSN Laboratories

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

Holds 4 active US DMFs for vortioxetine, filing since 2016. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
4 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Megafine Pharma (P)

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

Holds one active US DMF for vortioxetine, filing since 2024. 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
14

Dipharma Francis

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

Holds one active US DMF for vortioxetine, 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

Sigmapharm Laboratories

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

Holds one active US DMF for vortioxetine, filing since 2017. 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
16

Matrix Pharmacorp

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

Holds one active US DMF for vortioxetine, filing since 2017. 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
17

Seasons Biotechnology (Taizhou)

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

Holds one active US DMF for vortioxetine, 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
19

Beijing Hope Pharmaceutical

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

Holds 2 active US DMFs for vortioxetine, filing since 2020.

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

Zhejiang Huahai Pharmaceutical

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

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

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

17 more manufacturers hold filings for vortioxetine

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

Alembic PharmaceuticalsPiramal PharmaLek Pharmaceuticals D.DCiplaZydus LifesciencesRaks PharmaSymed LabsMorepen LaboratoriesMSN LaboratoriesMegafine Pharma (P)Dipharma FrancisSigmapharm LaboratoriesMatrix PharmacorpSeasons Biotechnology (Taizhou)Alp Pharm BeijingBeijing Hope PharmaceuticalZhejiang Huahai Pharmaceutical
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Contract manufacturers (3)

Dipharma Francis Italy Anfarm Hellas Greece Beijing Hmt Medical Technology China

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

Finished-dose makers (27)

H. Lundbeck A/S Denmark MSN Laboratories India Apotex Canada Dr. Reddy's Laboratories India Viatris United States STADA Arzneimittel Germany Eurofarma Laboratorios Brazil Rafarm Greece Siegfried Switzerland Laboratorios Cinfa S A Spain Elaiapharm France H. Lundbecks A/S Denmark Orion Finland “Gedeon Richter” Hungary Aristo Pharma Germany Ems S/A Brazil Germed Farmaceutica Ltda Brazil Hilton Pharma Pakistan Marcyrl Pharmaceutical Industries Egypt Krka Slovenia

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.

Who makes vortioxetine?

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

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Also on this molecule

Price history 4 yrs Shortages 5 Finished dose 27 Contract mfrs 3

By country

India 13

Export price by year

Year Median Exporters
2025 $3000.00 13
2024 $3307.92 15
2023 $3547.86 18
2022 $4455.00 13

US dollars per kilogram, customs export unit values.