Micrazym Capsule
Micrazym Capsule
Pancrelipase Delayed Release
Enteric Coated Micropellets in Capsules
Micrazym® is a pancreatin enzyme replacement medicine indicated for Exocrine Pancreatic Insufficiency (EPI). Conditions include cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy, and diabetes.
The product features a two-stage release system: enteric coated micropellets protect enzymes from gastric acid, then dissolve rapidly in the duodenum for targeted absorption.
Available in two strengths — 10,000 U and 25,000 U — to accommodate individual patient requirements
Product General Information
| Product | Micrazym® (Pancreatin) |
| Form | Enteric Coated Micropellets in Capsules / Delayed Release |
| Pellet Size | 0.8 – 1.8 mm |
| Pack Size | Pack of 50 capsules in Blisters | Pack of 100 capsules in HDPE bottles |
Key Features
- Enteric coated micropellets — full protection from gastric acid
- Rapid dissolution and absorption in the duodenum
- Blend of three naturally derived enzymes: Lipase, Amylase and Protease
- Capsule format — easy to administer and swallow
- Small pellet size (0.8–1.8 mm) for optimal GI distribution
- Two strengths for personalised patient dosing
Regulatory & Manufacturing
-
- EU GMP Certified manufacturing facility
- Saudi Arabia FDA GMP Certified
- EAEU GMP Certified
- Dossier: eCTD Format — Well Established Use pathway
- Terms: Dossier License and Product Supply
- Developed as per ICH and EMA guidelines
- Approved in 14 EU Member States
- Additionally approved in 8 non-EU countries
Pending global registration — growing market coverage
| COMPOSITION — ENZYME ACTIVITY PER CAPSULE (Ph. Eur.) |
| Enzyme (Ph. Eur.) | Micrazym® 10,000 U | Micrazym® 25,000 U |
| Lipase | 10,000 U | 25,000 U |
| Amylase | 8,000 U | 18,000 U |
| Protease | 600 U | 1,000 U |
| DOSSIER & REGULATORY INFORMATION |
| Format | Submission Route | Terms of License |
| eCTD Format (Developed as per applicable ICH and EMA guidelines) | Well Established Use | Dossier License and Product Supply |
|
Regulatory Approvals
• Approved in 14 EU Member States • Additionally approved in 8 non-EU countries • Pending global registration — expanding reach • High technological entry barrier — secure investment environment • Limited number of market competitors worldwide |
Business Opportunities
• Retail / OTC market opportunities • Tender / institutional business opportunities • Out-licensing with dossier and product supply • Reimbursable by most healthcare providers worldwide |
MARKET OPPORTUNITY — GLOBAL EPI THERAPEUTICS
Market Highlights
- Global EPI therapeutics market: US$ 2.27 billion (2021)
- Projected to reach US$ 3.75 billion by 2029 (CAGR 6.50%)
- CAGR of 6.50% (2022–2029)
- Growing market worldwide driven by rising diagnosis rates
- High technological entry barrier creates secure environment for investment
- Limited number of competitors in the global market
Why Micrazym®?
- Already approved in 22+ countries (14 EU + 8 non-EU)
- Multi-GMP certified manufacturing (EU, Saudi Arabia FDA, EAEU)
- Two strengths — broad patient coverage
- eCTD dossier ready for new market submissions
| KEY CONCLUSIONS |
| Two strengths (10,000 U and 25,000 U) allow personalised dosing for patients with varying degrees of Exocrine Pancreatic Insufficiency. |
| EU GMP, Saudi Arabia FDA GMP, and EAEU GMP certifications position Micrazym® for broad regulatory acceptance across multiple global markets. |
| Global EPI therapeutics market valued at US$ 2.27 billion (2021) is projected to reach US$ 3.75 billion by 2029 at a CAGR of 6.50% (Bridge Market Research). |
| Approved in 14 EU Member States and 8 non-EU countries, with pending global registration — supported by a high technology entry barrier and limited global competition. |
| Reimbursable by most healthcare providers worldwide — making Micrazym® an outstanding out-licensing and distribution opportunity for new market partners. |
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