Oral Solids & Liquids — Manufacturer & Supplier
Tablets, capsules, syrups, suspensions and dry powders — development batches through to commercial campaigns.
The oral block covers immediate and modified release tablets, hard gelatin and HPMC capsules, film coating, and liquid orals including syrups, suspensions and dry powder for reconstitution. Granulation is available as wet, dry and direct compression, with blend uniformity and content uniformity established during scale-up rather than assumed from the development batch. Dissolution profiles are developed in house across multiple media, which is usually where a transferred product either succeeds or has to be reformulated. Listed formulations describe manufacturing capability and qualified facility scope. They are not an offer of approved or marketed products, and any supply is subject to the customer holding the applicable marketing authorisation for the destination market.
Manufactured under the Stancor Pharma brand by Stancor Pharma.
Specifications
- Dosage forms
- Immediate and modified release tablets, film-coated tablets, hard capsules, syrups, suspensions, dry syrups, sachets
- Granulation
- Rapid mixer wet granulation, fluid bed, roller compaction and direct compression
- Batch envelope
- 25 kg to 500 kg blend; 50 L to 5,000 L for liquid orals
- Packing
- Alu-alu, blister, HDPE bottles, strip packing, bottles with measuring devices
- Development support
- Dissolution profiling in multiple media, blend and content uniformity, hardness and friability optimisation
- Stability
- ICH Zone IVb long-term (30 °C/75% RH) and accelerated (40 °C/75% RH)
Oral Solids & Liquids Applications
- Third-party manufacturing
- Loan licence manufacturing
- Nutraceutical ranges
- Paediatric liquid ranges
- Export supply
Applicable Standards & Specifications
- WHO-GMP
- Schedule M (CDSCO)
- ICH Q1A(R2)
- ICH Q8 principles
- USP/IP dissolution methods