Molecules / Mirtazapine / India

Mirtazapine API manufacturers in India

CAS 85650-52-8 ATC N06AX11 Updated 9 July 2026
15
India-based manufacturers with an active filing of 17 worldwide
$401.33
median export price per kg, all origins $343.77 to $546.50 · 31 exporters · 2025
Showing 9 of 15 India-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked India-based 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
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
04

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
05

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
06

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
07

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
08

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
09

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

6 more manufacturers in India 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.

Open the full list with a free account

How this list is built

This page filters the worldwide Mirtazapine manufacturer list to companies based in India. 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. Read the full method.

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