Molecules / Sodium Cromoglicate

Sodium Cromoglicate API manufacturers

Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
3
shortage records on file across 2 countries
120
finished-dose makers across 12 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Micro Labs

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

Holds 2 valid CEPs for sodium cromoglicate, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
None on file
CEP
2 valid
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced EDQM certificate database
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02

Cambrex Profarmaco Milano

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

Holds one valid CEP for sodium cromoglicate, filing since 2024. Its 2022 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2022 · NAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
03

Fermion Oy

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

Holds one valid CEP for sodium cromoglicate, filing since 2025. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile
04

Olon

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

Holds one valid CEP for sodium cromoglicate, filing since 2024. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
How this listing is sourced EDQM certificate database
View profile
05

Aurore Life Sciences

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

Holds one valid CEP for sodium cromoglicate, filing since 2025. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
View profile

2 more manufacturers hold filings for sodium cromoglicate

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

OlonAurore Life Sciences
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Finished-dose makers (16)

FDC India Viatris United States Cooperation Pharmaceutique Francaise France Gilead Sciences United States Ursapharm Arzneimittel Germany Egyptian International Pharmaceutical Industries Co. (EIPICO) Egypt Ciron Drugs & Pharmaceuticals India Opella Healthcare Brazil Ltda Brazil STADA Arzneimittel Germany Ernest Chemist Ghana Ivee Aqua Epz Kenya Merit Organics India Zaklady Farmaceutyczne Polpharma Poland Ashford Pharmaceutical Laboratories Philippines Cooper Sa Pharmaceuticals Greece Jamjoom Pharmaceuticals Factory Saudi Arabia

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 sodium cromoglicate?

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

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Also on this molecule

Shortages 3 Recalls 1 Finished dose 16 Contract mfrs 0