Egypt API Registration Analysis — Q4 Overview

This dashboard provides an insight into API registrations in Egypt, highlighting market activity, applicant trends, reference standards, and country-level participation. The data reflects a strong contribution from Indian manufacturers and a healthy mix of products entering the regulatory system.

Overall Snapshot

Total APIs registered: 24

Unique products covered: 21

Average time to expiry: 4.79 years

Indian market share: 70.8%

Total holders: 18

The numbers indicate a moderately diverse API portfolio, with strong dominance from Indian companies.

Registration by Applicant Country

Egypt — 18 registrations (75%)

India — 3 registrations (12.5%)

China — 3 registrations (12.5%)

These figures represent the number of unique applicants registering APIs, which is why the counts differ from the monthly holder-country filings. The high domestic share highlights strong engagement from Egyptian registrants, supported by additional contributions from India and China.

Registration by Reference Type

In-house: 12 registrations (50%)

Ph. Eur.: 6 registrations (25%)

USP: 5 registrations (20.83%)

BP: 1 registration (4.17%)

The significant use of in-house references suggests that many manufacturers prefer internal quality systems, complemented by established pharmacopoeial standards like Ph. Eur. and USP.

Products With the Highest DMF Counts

Empagliflozin — 2 DMFs

Linagliptin — 2 DMFs

Sacubitril Valsartan Trisodium — 2 DMFs

These products show higher interest and competitive activity, indicating increased demand and more players targeting the same therapeutic classes.

Key Takeaways for Stakeholders

The Egypt API registration landscape reflects stable growth and strong regional involvement, with Indian manufacturers playing a major role in filings and market share. The mix of in-house and pharmacopoeial references highlights maturity in quality systems, while the concentration around select APIs suggests competitive positioning in high-demand therapeutic categories.

Overall, the data showcases an active and evolving registration environment—one that continues to attract both domestic and global participants.