Molecules / Paliperidone

Paliperidone API manufacturers

CAS 144598-75-4 ATC N05AX13 Updated 9 July 2026
23
manufacturers with an active filing 22 of them hold a US DMF or a CEP
$4305.00
median export price per kg $3579.82 to $47439.21 · 7 exporters · 2025
17
shortage records on file across 6 countries
400
finished-dose makers across 42 regulators
Showing 20 of 23 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Cadila Pharmaceuticals

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

Holds one active US DMF for paliperidone, filing since 2010. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 15 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
15 markets
How this listing is sourced FDA, List of Drug Master Files
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02

Qilu Pharmaceutical

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

Holds one active US DMF for paliperidone, filing since 2021. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 7 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
7 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 2 active US DMFs for paliperidone, filing since 2011. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 26 markets.

US DMF
2 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 paliperidone, filing since 2011. 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

Macleods Pharmaceuticals

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

Holds one active US DMF for paliperidone, filing since 2022. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 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
06

Gland Pharma

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

Holds one active US DMF for paliperidone, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 19 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
19 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

MSN Laboratories

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

Holds 2 active US DMFs for paliperidone, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

Piramal Pharma

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

Holds one active US DMF for paliperidone, filing since 2018. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Pharmathen

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

Holds one active US DMF for paliperidone, filing since 2016. Its GMP is recognised in 18 markets.

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

Alivus Life Sciences

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

Holds 2 active US DMFs for paliperidone, filing since 2010. 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
11

Orchid Pharma

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

Holds one active US DMF for paliperidone, filing since 2011. 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
12

Interquim

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

Holds 2 active US DMFs for paliperidone, filing since 2016. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Apitoria Pharma

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

Holds 2 active US DMFs for paliperidone, filing since 2020. Its 2025 FDA inspection closed as VAI.

US DMF
2 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
14

Neuland Laboratories

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

Holds 4 active US DMFs for paliperidone, filing since 2012. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
4 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Megafine Pharma (P)

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

Holds one active US DMF for paliperidone, 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
16

Unimark Remedies

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

Holds one active US DMF for paliperidone, filing since 2010. 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
17

Amino Chemicals

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

Holds one active US DMF for paliperidone, filing since 2010. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Jubilant Biosys

India
Makes the API

Holds 4 active US DMFs for paliperidone, filing since 2009. Its 2022 FDA inspection closed as VAI.

US DMF
4 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
19

Matrix Pharmacorp

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

Holds 3 active US DMFs for paliperidone, filing since 2009. Its 2025 FDA inspection closed as VAI.

US DMF
3 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
20

Sintenovo SA de CV

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

Holds one active US DMF for paliperidone, filing since 2012.

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

20 more manufacturers hold filings for paliperidone

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

ApotexMacleods PharmaceuticalsGland PharmaMSN LaboratoriesPiramal PharmaPharmathenAlivus Life SciencesOrchid PharmaInterquimApitoria PharmaNeuland LaboratoriesMegafine Pharma (P)Unimark RemediesAmino ChemicalsJubilant BiosysMatrix PharmacorpSintenovo SA de CV
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Contract manufacturers (4)

Neuland Laboratories India Biological E India Savior Lifetec Taiwan Inke Spain

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

Finished-dose makers (33)

Ajanta Pharma India Amneal United States Janssen-Cilag Manufacturing Puerto Rico Alembic Pharmaceuticals India Shandong Luye Pharmaceutical China Zentiva, k.s Czech Republic Janssen-Cilag Farmaceutica Ltda Brazil Eskayef Pharmaceuticals Bangladesh Tolmar United States Cilag Switzerland Teva Israel Tris Pharma United States Viatris United States Neuraxpharm Pharmaceuticals S L Spain ANI Pharmaceuticals United States Janssen Pharmaceutica Belgium Laboratorios Liconsa Spain Caplin Point Laboratories India Inventia Healthcare India Lupin India

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.

Who makes paliperidone?

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

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Also on this molecule

Price history 4 yrs Shortages 17 Recalls 5 Finished dose 33 Contract mfrs 4

By country

India 14

Export price by year

Year Median Exporters
2025 $4305.00 7
2024 $47567.03 5
2023 $49187.50 16
2022 $50812.29 6

US dollars per kilogram, customs export unit values.