Molecules / Clozapine

Clozapine API manufacturers

CAS 5786-21-0 ATC N05AH02 Updated 9 July 2026
13
manufacturers with an active filing 12 of them hold a US DMF or a CEP
$135.00
median export price per kg $95.41 to $203.80 · 18 exporters · 2025
10
shortage records on file across 3 countries
328
finished-dose makers across 46 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

03

Mankind Pharma

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

Holds 2 active US DMFs for clozapine, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 14 markets.

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

Medichem

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

Holds one active US DMF for clozapine, filing since 1993. 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
07

Cohance Lifesciences

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

Holds 2 active US DMFs for clozapine, filing since 2017. 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
08

R.L.Fine Chem

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

Holds one active US DMF for clozapine, filing since 2023. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 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
09

Matrix Pharmacorp

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

Holds one active US DMF for clozapine, filing since 2013. 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
11

SMS Pharmaceuticals

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

Holds one active US DMF for clozapine, filing since 2024. Its 2025 FDA inspection closed as OAI, and its GMP is recognised in 6 markets.

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

Global Calcium

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

Holds one active US DMF for clozapine, filing since 2022. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 3 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · OAI
GMP recognised in
3 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

'Công ty cổ phần dược phẩm ME DI SUN

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for clozapine. 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

10 more manufacturers hold filings for clozapine

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

Contract manufacturers (4)

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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By country

Export price by year

Year Median Exporters
2025 $135.00 18
2024 $151.94 12
2023 $176.34 15
2022 $152.00 13

US dollars per kilogram, customs export unit values.