Molecules / Buspirone

Buspirone API manufacturers

CAS 36505-84-7 ATC N05BE01 Updated 9 July 2026
11
manufacturers with an active filing 11 of them hold a US DMF or a CEP
22
shortage records on file across 3 countries
151
finished-dose makers across 26 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Zydus Lifesciences

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

Holds one active US DMF and one valid CEP for buspirone, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Cohance Lifesciences

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

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

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

Fermion Oy

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

Holds one active US DMF and one valid CEP for buspirone, filing since 1994. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
FDA, List of Drug Master Files
View profile
05

Maithri Drugs

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

Holds 2 active US DMFs and one valid CEP for buspirone, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 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
07

Excella Gmbh

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

Holds one active US DMF for buspirone, filing since 1991. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
7 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Unichem Laboratories

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

Holds one valid CEP for buspirone, filing since 2024. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2026 · VAI
GMP recognised in
13 markets
How this listing is sourced EDQM certificate database
View profile
09

Unimark Remedies

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

Holds one active US DMF for buspirone, filing since 2011. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Jiangsu Nhwa Pharmaceutical

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

Holds one active US DMF for buspirone, filing since 2024. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
11

R.L.Fine Chem

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

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

8 more manufacturers hold filings for buspirone

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

Fermion OyMaithri DrugsMedilux LaboratoriesExcella GmbhUnichem LaboratoriesUnimark RemediesJiangsu Nhwa PharmaceuticalR.L.Fine Chem
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Contract manufacturers (2)

Fermion Oy Finland Orion Finland

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

Finished-dose makers (27)

Epic Pharma United States Pharmascience Canada Viatris United States Orion Finland Teva Israel Rising United States Bristol-Myers Squibb United States Egis Pharmaceuticals Hungary Bristol Myers Squibb Manufacturing United States Eurofarma Laboratorios Brazil Inventia Healthcare India Jamp Pharma Canada Laboratoires Pro Doc Limitée Canada Mint Pharmaceuticals Canada Sandoz Switzerland Smithkline Beecham United Kingdom Aristo Pharma Germany Calox Venezuela Cipan - Companhia Industrial Produtora De Antibioticos Portugal

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

Who makes buspirone?

Ask Fred which manufacturers are on record for buspirone and what filings they hold.

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Also on this molecule

Shortages 22 Recalls 9 Finished dose 27 Contract mfrs 2

By country

India 8