Molecules / Mirtazapine

Mirtazapine API manufacturers

CAS 85650-52-8 ATC N06AX11 · Other antidepressants Updated 9 July 2026
17
manufacturers with an active filing 12 of them hold a US DMF or a CEP
$401.33
median export price per kg $343.77 to $546.50 · 31 exporters · 2025
141
shortage records on file across 6 countries
624
finished-dose makers across 45 regulators
Showing 17 of 17 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Micro Labs

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

Holds one active US DMF and 2 valid CEPs for mirtazapine, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
02

Neuland Laboratories

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

Holds 6 active US DMFs and one valid CEP for mirtazapine, filing since 2002. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

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

Medichem

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

Holds one active US DMF for mirtazapine, filing since 2001. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Hetero

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

Holds 2 active US DMFs for mirtazapine, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.

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

Apitoria Pharma

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

Holds 2 active US DMFs and 2 valid CEPs for mirtazapine, filing since 2003. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Megafine Pharma (P)

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

Holds 2 active US DMFs for mirtazapine, filing since 2007. Its 2023 FDA inspection closed as VAI.

US DMF
2 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
08

Matrix Pharmacorp

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

Holds one active US DMF for mirtazapine, filing since 2006. 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
10

Aspen Oss

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

Holds one active US DMF for mirtazapine, filing since 1993.

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
11

Mahi Drugs

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

Holds one active US DMF for mirtazapine, filing since 2024.

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
13

Agimexpharm Pharmaceutical

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for mirtazapine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
14

Aurobindo Pharma

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for mirtazapine. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 21 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · OAI
GMP recognised in
21 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
15

'Công ty cổ phần dược phẩm ME DI SUN

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for mirtazapine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
16

Công ty TNHH Liên doanh Hasan - Dermapharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for mirtazapine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Meyer Bpc Joint Venture

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for mirtazapine. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

14 more manufacturers hold filings for mirtazapine

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

MedichemHeteroApitoria PharmaMegafine Pharma (P)Matrix PharmacorpSyn-Tech Chem. & PharmAspen OssMahi DrugsZhejiang Liaoyuan PharmaceuticalsAgimexpharm PharmaceuticalAurobindo Pharma'Công ty cổ phần dược phẩm ME DI SUNCông ty TNHH Liên doanh Hasan - DermapharmMeyer Bpc Joint Venture
Open the full list with a free account

Contract manufacturers (2)

Neuland Laboratories India Unison Pharmaceuticals India

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

Finished-dose makers (46)

Viatris United States Sandoz Switzerland Torrent Pharmaceuticals India Zentiva, k.s Czech Republic Apotex Canada Amneal United States Cadila Pharmaceuticals India Teva Israel Dechra Zydus Lifesciences India Orion Finland Ethypharm France Sanofi France Eurofarma Laboratorios Brazil Gilead Sciences United States Merck Sharp & Dohme Farmaceutica Ltda Brazil Novitium Pharma United States Organon Pharma (Uk) United Kingdom Anesta United States Medreich India

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 mirtazapine 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 4 yrs Shortages 141 Recalls 2 Finished dose 46 Contract mfrs 2

By country

India 15

Export price by year

Year Median Exporters
2026 YTD $369.94 13
2025 $401.33 31
2024 $440.00 31
2023 $444.83 32

US dollars per kilogram, customs export unit values.