Non Sterile Manufacturing

Our Sevenoaks GMP facility, commissioned in November 2021 and operational since August 2022, supports the full product lifecycle—from early-phase clinical development right through to commercial supply.

We manufacture a comprehensive range of tablets, capsules, and oral liquid products, supported by integrated packaging, labelling, QP release, storage, and global distribution to both EU and UK markets.

Our Non-Sterile Manufacturing Capabilities

Tablets (Active & Placebo)

• Throughput capacity of 40,000 tablets per hour
• Tablet sizes 5 mm–25 mm
• Full GMP control of weight, hardness, friability, dissolution, and uniformity
• Coated & uncoated tablet manufacturing
• Production for Phase I, II, III and commercial supply
• Placebo tablets engineered to match active products in appearance, texture, taste, smell, and disintegration, ensuring robust blinding for IMP trials
• Annex 13–aligned manufacturing and documentation

Capsules (Active, Placebo & Over-Encapsulated)

• GMP capsule filling for early-phase through commercial supply
• Over-encapsulation for comparator blinding
• Full shell, colour, and size matching
• Weight balancing and rattle prevention
• Suitable for complex blinding and randomised study designs
• Supports IMPs, comparators & NIMPs

Oral Liquids

• GMP manufacturing of solutions and suspensions
• Taste-masking for improved patient acceptability
• Suitable for Phase I–III and commercial supply
• Full QC release testing and stability programme support

Placebo Manufacturing & Blinding Solutions

Eramol provides specialised placebo development and blinding services, including:

• Matched placebos (visual, sensory & functional attributes)
• Liquid placebo formulation & sensory matching
• Over-encapsulation of tablets/capsules
• Packaging and labelling blinding strategies
• Controlled processes to protect blinding integrity throughout the supply chain

Our expertise ensures robust data integrity and regulatory compliance across Phase I–III studies.

Integrated Packaging & Labelling Services

Eramol delivers full primary and secondary packaging services for non-sterile products:

Primary Packaging

• Blistering
• Bottling
• Liquid bottle filling (with tamper-evident seals)
• Single-dose& multi-dose formats

Secondary Packaging

• Cartons, kits, and clinical study packs
• Ancillary management
• Full reconciliation and batch documentation

GMP Labelling Services

• Single-panel labels
• Booklet labels
• Just-In-Time (JIT) clinical labelling
• Regulatory and multilingual label control
• Verification systems supporting Annex 13 and commercial requirements

These services integrate seamlessly with QP release and global distribution.

QP Release, Regulatory Support & Compliance

Founded by two Qualified Persons, Eramol operates with quality at its core.
We provide:

• UK & EU QP certification
• IMP & commercial batch release
• Annex 13 and EU GMP guidance throughout development
• Inspection-ready documentation
• Early regulatory input to reduce risk and shorten timelines

Our internal QPs ensure full compliance for both clinical and commercial non-sterile manufacture.

GMP Storage & Global Distribution

Eramol offers controlled storage environments across:

• Ambient
• 2–8°C
• -20°C
• -80°C

Global distribution services include:

• GDP-certified courier network
• Validated shipping systems
• Temperature monitoring & chain-of-custody
• Global clinical site fulfillment

This ensures safe, compliant delivery from manufacturing to trial or commercial destinations.

Why Choose Eramol for Non-Sterile Manufacturing?

• End-to-end service from formulation → manufacture → packaging → labelling → QP release → storage → global distribution
• Supports Phase I, II, III, and commercial supply
• Sevenoaks GMP facility operational since 2022
• Quality-first culture led by QP founders
• Excellence in placebo matching, over-encapsulation and blinding
• High-throughput capability (40,000 tablets/hour)
• Flexible batch sizes ideal for clinical and niche commercial supply
• Strong regulatory, QP and GMP compliance
• Single-provider efficiency and reduced supply chain risk