Why Two Piece Hard Capsule Filling Matters for Supplement Brands
At SREKE, we understand that choosing the right dosage form is critical for supplement brand success. Two piece hard capsules—both vegetarian (HPMC) and gelatin—represent over 30% of the global oral solid dosage market, valued at approximately $38 billion in 2023 (Grand View Research). For brand owners, distributors, and e-commerce sellers, hard capsules offer unmatched advantages: precise dosing, tamper-evident seals, excellent bioavailability, and consumer preference for easy-to-swallow formats.
Common challenges include achieving uniform fill weights, avoiding cross-contamination, and ensuring stability of hygroscopic or oil-based ingredients. At SREKE, our GMP-certified hard capsule filling services address these issues with advanced encapsulation technology and rigorous quality control.
Key Manufacturing Considerations at SREKE
Formulation and Dosage Forms
We handle a wide range of formulations—powders, granules, pellets, mini-tablets, and even semi-solids—for size 00, 0, 1, 2, 3, and 4 capsules. Our formulation team pre-tests flowability, moisture sensitivity, and excipient compatibility to ensure consistent fill weights and dissolution profiles.
Quality Standards
Our facility complies with cGMP (21 CFR Part 111), ISO 22000, and HACCP standards. Every batch undergoes in-process checks (weight variation, hardness, disintegration at 37°C) and finished product testing for identity, potency, heavy metals, microbial limits, and stability. We provide a Certificate of Analysis (COA) for each order.
Regulatory Compliance
We support FDA registration, NDC listing, and EFSA Novel Food notifications. All capsules are manufactured with food-grade excipients and meet USP/EP pharmacopoeial specifications. Our supplier qualification program ensures traceability for every raw material.
How SREKE Helps You Get to Market Faster
Our OEM/ODM process is streamlined for speed without compromising quality:
- Initial consultation: Discuss your formulation goals, target market, and packaging needs.
- R&D formulation: We develop samples within 5–7 business days, adjusting for stability and potency.
- Pilot batch: Scale-up with 10,000–50,000 capsules for stability testing or sample distribution.
- Full production: MOQ starts at 100,000 capsules per SKU; lead time averages 15–20 business days for standard orders.
- Custom packaging: We offer bottles, blister packs, stick packs, and co-packing with desiccants and cotton.
What sets us apart is our integrated in-house lab for accelerated stability testing (ICH guidelines) and our dedicated project manager assigned to every account.
Industry Trends and Market Opportunities
The global vegan capsule market is projected to grow at 8.9% CAGR through 2030 (Inkwood Research). Consumer demand for plant-based, clean-label supplements is driving interest in HPMC capsules from cellulose or pullulan. At SREKE, we offer both gelatin and HPMC options, including delayed-release enteric capsules for sensitive ingredients like probiotics and omega oils.
E-commerce sellers increasingly need differentiated packaging—custom colors, printing, and blister cards. We provide capsule banding, polishing, and sorting to meet retail and online marketplace standards.
Frequently Asked Questions
Q: What is your minimum order quantity (MOQ) for hard capsule filling?
A: Our MOQ is 100,000 capsules per SKU. For smaller pilot runs, we can accommodate 10,000–50,000 capsules at a higher cost per unit.
Q: Do you offer vegetarian (HPMC capsules) filling?
A: Yes, we fill both gelatin and HPMC capsules. HPMC capsules have lower moisture content (2–4%) and are suitable for moisture-sensitive ingredients.
Q: How do you ensure uniform fill weight and content uniformity?
A: We use automated encapsulation machines with real-time weight feedback, and we conduct in-process weight checks every 15 minutes. Final batch content uniformity is tested per USP <905>.
Q: What documentation do you provide for FDA registration?
A: We supply a complete manufacturing dossier, including formulation details, in-process and finished product tests, stability data, and a Certificate of Analysis. We can also generate a Drug Master File (DMF) or supplement-type filing upon request.
Ready to launch your supplement brand? SREKE provides GMP-certified OEM/ODM manufacturing for softgels, capsules, tablets, powders, gummies, and liquids. Contact us for a free quote or email [email protected] — we respond within 24 hours.