Molecules / Esketamine

Esketamine API manufacturers

CAS 33643-46-8 ATC N01AX14 Updated 9 July 2026
6
manufacturers with an active filing 6 of them hold a US DMF or a CEP
2
shortage records on file across 2 countries
90
finished-dose makers across 30 regulators
Showing 6 of 6 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Arevipharma

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

Holds one active US DMF and one valid CEP for esketamine, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Maithri Drugs

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

Holds one active US DMF and one valid CEP for esketamine, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

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

Alkem Laboratories

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

Holds one active US DMF for esketamine, filing since 2022. Its GMP is recognised in 21 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
21 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Supriya Lifescience

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

Holds 2 active US DMFs for esketamine, filing since 2021. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Nortec Quimica

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

Holds one active US DMF for esketamine, filing since 2022. 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

3 more manufacturers hold filings for esketamine

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

Alkem LaboratoriesSupriya LifescienceNortec Quimica
Open the full list with a free account

Finished-dose makers (10)

Renaissance Lakewood United States Sintetica Switzerland Pfizer United States Janssen Ortho Puerto Rico Pfizer Brasil Ltda Brazil Janssen Pharmaceutica Belgium Janssen-Cilag Farmaceutica Ltda Brazil Uniao Quimica Farmaceutica Nacional S A Brazil Santisa Laboratorio Farmaceutico Brazil Novell Pharmaceutical Laboratories Indonesia

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

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Also on this molecule

Shortages 2 Finished dose 10 Contract mfrs 0

By country

India 5