Company (Headquarters):

United Kingdom

Types of Drugs Manufactured:

Small Molecule; Biologics

CDMO Services:

Drug Substance Manufacturing (API)

Delivering services from development to commercial scale of advanced intermediates & API for small molecules (including highly potent) and peptides. Adding value through the application of technology solutions, including biocatalysis, 14C radiolabelling, flow chemistry, and physical sciences.

Drug Product/FDF

Specialise in oral dose forms: API in capsules/bottles, tablets & mini-tablets, granules, beads/pellets, powders, non-sterile liquids, and specialist paediatric solutions

Packaging(Commercial)

Primary packaging – bottles, blisters & sachets. Secondary packaging – bottles, vial/ampoules, cartons, autoinjectors, wallets, blisters, sachets, stick packs, pre-filled syringes. Includes specialist packaging: paediatric packaging solutions and ATMP packaging (-20°c to -80°c)

Regulatory Services

Tailored regulatory services for all phases of product development and approval. Includes document drafting, reviewing, compilation, and submission.

Analytical Services

Providing a full suite of analytical testing services across global FDA-approved laboratories. Encompassing method development, validation, transfer, and stability studies on small molecules, biologics, active ingredients, and finished products (including controlled substances).

Packaging (Clinical)

Primary packaging – bottles, blisters & sachets
Secondary packaging – bottles, vial/ampoules, cartons, autoinjectors, wallets, blisters, sachets, stick packs, pre-filled syringes.

Process & Formulation Development

Development of small molecule APIs, including potent & highly potent. From non-GMP to GMP development to clinical supply (Phase 1 – 3) to scale up for commercialisation.

Supply Chain Logistics

Customised distribution services with full traceability of materials from receipt, storage, processing & final dispatch. Includes Cold Chain Logistics for commercial ATMP products (-20°c to -80°c)

Therapeutic Area:

Cardiovascular; Central Nervous System; Dermatology; Diagnostics and Monitoring; Digital Health; Ear Nose Throat and Oral health; Endocrine and Hormonal; Gastrointestinal and Metabolism; Genito Urinary and Women's Health; Hematology; Immunology; Infectious Disease; Medical Devices; Musculoskeletal System; Nutritional; Oncology; Ophthalmology; Platform Technologies; Radiopharmaceuticals; Rare and Genetic Disorders; Respiratory; Wounds and Injuries; Pain Symptoms

High Potent Products capabilities:

OEB 3 Medium Potency; OEB 4-5 Highly Potent APIs (HPAPIs)

Facilities Location:

Europe, North America, South-East Asia, East Asia

Regulatory Approvals for facilities:

USA - FDA;Europe - EMA or constituent countries;UK - MHRA;GMP;ISO 9001;Canada - Health Canada;Brazil - ANVISA;South Korea - MFDS;ISO 14001

Manufacturing Technologies:

Tablets/Capsules

Current Capacity:

Expansive non-GMP and GMP drug substance and drug product development, manufacturing, and packaging capacity across Europe and the US