Molecules / Memantine

Memantine API manufacturers

CAS 19982-08-2 ATC N06DX01 Updated 9 July 2026
28
manufacturers with an active filing 23 of them hold a US DMF or a CEP
$498.92
median export price per kg $364.92 to $600.00 · 22 exporters · 2025
54
shortage records on file across 6 countries
657
finished-dose makers across 45 regulators
Showing 20 of 28 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Olpha

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

Holds one active US DMF for memantine, filing since 2007. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 9 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
9 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Macleods Pharmaceuticals

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

Holds 2 active US DMFs for memantine, filing since 2010. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
2 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
03

Dr. Reddy's Laboratories

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

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

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Apotex

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

Holds one active US DMF for memantine, filing since 2007. 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
View profile
05

Lupin

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

Holds one active US DMF for memantine, filing since 2007. 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
06

Alembic Pharmaceuticals

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

Holds one active US DMF for memantine, filing since 2009. 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
07

Hetero

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

Holds 2 active US DMFs for memantine, filing since 2011. 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
08

Zydus Lifesciences

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

Holds one active US DMF for memantine, filing since 2021. 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
09

Olon

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

Holds one active US DMF for memantine, filing since 2005. 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
10

Megafine Pharma (P)

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

Holds one active US DMF for memantine, filing since 2011. 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
11

Cohance Lifesciences

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

Holds 2 active US DMFs for memantine, filing since 2015. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Sharon Bio-Medicine

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

Holds one active US DMF for memantine, filing since 2011. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Industriale Chimica

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

Holds one active US DMF for memantine, filing since 2006. 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
14

Orbion Pharmaceuticals

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

Holds one active US DMF for memantine, filing since 2007.

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
15

PROCOS

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

Holds one active US DMF for memantine, filing since 2012. Its 2022 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16

Unichem Laboratories

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for memantine. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
13 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
17

Matrix Pharmacorp

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

Holds one active US DMF for memantine, filing since 2007. 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
18

Zhejiang Supor Pharmaceuticals

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

Holds one active US DMF for memantine, filing since 2023. 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
19

MSN Pharmachem

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

Holds 2 active US DMFs for memantine, filing since 2008. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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
20
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for memantine, filing since 2026. Its GMP is recognised in 5 markets.

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

Contract manufacturers (7)

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 $498.92 22
2024 $500.00 32
2023 $525.00 36
2022 $616.00 29

US dollars per kilogram, customs export unit values.