Molecules / Olopatadine

Olopatadine API manufacturers

CAS 113806-05-6 ATC R01AC08 Updated 9 July 2026
11
manufacturers with an active filing 8 of them hold a US DMF or a CEP
$3450.00
median export price per kg $2302.66 to $6414.68 · 12 exporters · 2025
38
shortage records on file across 4 countries
362
finished-dose makers across 49 regulators
Showing 11 of 11 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

MSN Laboratories

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

Holds one active US DMF for olopatadine, filing since 2011. 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
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02

FDC

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

Holds one active US DMF for olopatadine, filing since 2015. Its 2023 FDA inspection closed as NAI, and its GMP is recognised in 16 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · NAI
GMP recognised in
16 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

USV

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

Holds one active US DMF for olopatadine, filing since 2011. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 9 markets.

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

Curia Spain S.A.U

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

Holds 2 active US DMFs for olopatadine, filing since 2006. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 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
05

Alivus Life Sciences

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

Holds 2 active US DMFs for olopatadine, 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
06
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for olopatadine, filing since 2012. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Pcas

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

Holds one active US DMF for olopatadine, filing since 2010. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

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

Kyowa Pharma Chemical

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

Holds one active US DMF for olopatadine, filing since 2014. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Crystal Pharma, S.A.U

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for olopatadine. 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
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10

Medigraph Pharmaceuticals

India
Makes the APIFinished dose

Registered with SFDA (Saudi Arabia) for olopatadine. 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
11

Công ty cổ phần Tập đoàn Merap

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for olopatadine. 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

8 more manufacturers hold filings for olopatadine

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

Curia Spain S.A.UAlivus Life SciencesF.I.S. – Fabbrica Italiana SinteticiPcasKyowa Pharma ChemicalCrystal Pharma, S.A.UMedigraph PharmaceuticalsCông ty cổ phần Tập đoàn Merap
Open the full list with a free account

Contract manufacturers (2)

F.I.S. – Fabbrica Italiana Sintetici Italy Rafarm Greece

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

Finished-dose makers (34)

Glenmark Pharmaceuticals s.r.o Czech Republic Apotex Canada Amneal United States Alembic Pharmaceuticals India Allegiant Health United States Gilead Sciences United States Ajanta Pharma India HIKMA ITALIA Italy Viatris United States Zentiva, k.s Czech Republic Micro Labs India Alcon Research United States Square Pharmaceuticals Bangladesh Lincoln Pharmaceuticals India Alcon Laboratories United States Centaur Pharmaceuticals India Mint Pharmaceuticals Canada Novartis Switzerland Sandoz Switzerland Beximco Pharmaceuticals Bangladesh

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 38 Recalls 13 Finished dose 34 Contract mfrs 2

By country

India 7

Export price by year

Year Median Exporters
2025 $3450.00 12
2024 $3387.88 15
2023 $3633.51 12
2022 $5396.19 14

US dollars per kilogram, customs export unit values.