Molecules / Prucalopride

Prucalopride API manufacturers

CAS 179474-81-8 ATC A06AX05 Updated 9 July 2026
13
manufacturers with an active filing 10 of them hold a US DMF or a CEP
$13500.00
median export price per kg $9036.58 to $16375.00 · 6 exporters · 2025
26
shortage records on file across 3 countries
146
finished-dose makers across 30 regulators
Showing 13 of 13 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Torrent Pharmaceuticals

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

Holds one active US DMF for prucalopride, filing since 2023. Its 2026 FDA inspection closed as NAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · NAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Alembic Pharmaceuticals

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

Holds one active US DMF for prucalopride, filing since 2023. 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
03

MSN Laboratories

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

Holds one active US DMF for prucalopride, filing since 2022. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.

US DMF
1 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
04

Symed Labs

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

Holds 2 active US DMFs for prucalopride, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 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
05

Shilpa Pharma Lifesciences

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

Holds one active US DMF for prucalopride, filing since 2020. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 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
06

Biophore India Pharmaceuticals

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

Holds one active US DMF for prucalopride, filing since 2022. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.

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

Apitoria Pharma

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

Holds one active US DMF for prucalopride, filing since 2025. 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
08

Medichem Manufacturing (Malta)

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

Holds one active US DMF for prucalopride, filing since 2022. Its 2018 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Erythro Pharma

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

Holds 2 active US DMFs for prucalopride, filing since 2024.

US DMF
2 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
10

Ss Pharma

United States
Makes the API

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

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
11

Pt Kimia Farma Persero Tbk

Indonesia
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for prucalopride. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
12

Metrochem API

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for prucalopride. Its GMP is recognised in 2 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
13

Công ty TNHH Liên doanh Hasan - Dermapharm

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for prucalopride. 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 prucalopride

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

Symed LabsShilpa Pharma LifesciencesBiophore India PharmaceuticalsApitoria PharmaMedichem Manufacturing (Malta)Erythro PharmaSs PharmaPt Kimia Farma Persero TbkMetrochem APICông ty TNHH Liên doanh Hasan - Dermapharm
Open the full list with a free account

Contract manufacturers (4)

Biophore India Pharmaceuticals India Shilpa Pharma Lifesciences India Savior Lifetec Taiwan Metrochem API India

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

Finished-dose makers (23)

Apotex Canada Ajanta Pharma India HIKMA ITALIA Italy Cipla India Lupin India Sandoz Switzerland Zentiva, k.s Czech Republic Specgx United States Teva Israel ANI Pharmaceuticals United States Amneal Pharmaceuticals NY United States Jamp Pharma Canada Siegfried Switzerland Aet Laboratories India Akums Drugs & Pharmaceuticals India Alkem Laboratories India Dexcel Pharma Israel Janssen-Cilag Farmaceutica Ltda Brazil STADA Arzneimittel Germany Synthon Netherlands

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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Also on this molecule

Price history 4 yrs Shortages 26 Recalls 2 Finished dose 23 Contract mfrs 4

By country

India 15

Export price by year

Year Median Exporters
2025 $13500.00 6
2024 $11537.29 8
2023 $14634.15 9
2022 $26007.67 9

US dollars per kilogram, customs export unit values.