Softigel by Procaps

The company’s distinguishing strengths allow it to move into difficult-to-manufacture dosage forms, formulations, compounds and non-traditional production methods.

Working on developing opportunities with resilient long-term partnerships from breakthrough technologies, Softigel by Procaps is infused with a strong belief in the developing need for generic drugs, advanced delivery technologies and speciality pharma products.

Due to the company’s vertical integration and cutting-edge research and development (R&D), Softigel by Procaps is uniquely qualified to meet the market’s requirements.

The company works alongside both small and large pharmaceutical businesses seeking integrated, strategic partners offering advanced technologies and expertise, driving demand for integrated services from proof-of-concept to commercialisation.

Drug delivery technologies

Softigel by Procaps provides an extensive portfolio, with a vast array of products ranging from a single unit dosage form to multiple delivery systems in one dose. The company’s softgel-related technologies include:

• Twist-off capsules
• Chewgels™, chewable soft capsules
• G-Tabs™, gelatine-coated tablets
• Versagels™, soft chewable capsules free from animal derivatives
• Unigel™, a novel technology for fixed-dose combinations

Other technologies offered by the company comprise:

• Hard gel capsules
• Gels
• Ointments
• Creams
• Prefilled syringes
• Powders
• Tablets
• Omega-3 high concentrates
• Gummygels™, nutraceutical gummies

Product development services

Softigel by Procaps’ pioneering softgel facilities comprises a fully integrated product development services (PDS) unit, which, in the same plant, covers a vast array of product lifecycle phases from early development to commercialisation.

The company’s contemporary facility employs equipment replication from lab-scale through to small-scale good manufacturing practice (GMP) batches, as well as full-scale commercial GMP.

Its R&D team provides clients with access to encapsulation in softgel dosage forms or other delivery systems, differentiated OTC products and nutritional supplements, formulation of simple or highly complex products, high or low potent active pharmaceutical ingredients (APIs), traditional and unique delivery systems, and value and support throughout all stages.

Softigel by Procaps has proven expertise in manufacturing technologies, product development, product launches and technology transfers, enabling its clients to surmount formulation challenges.

The specialised team works intimately alongside its clients to better understand expectations and develop a regulatory strategy that ensures optimum quality, timely submissions, and quicker, more positive registration results.

The company also has extensive knowledge in preparing submissions in electronic clinical trial document (eCTD) format, offering support during the application phase, including annual reports, as well as other post-approval applications.

R&D services for advanced pharmaceutical formulations

A primary factor in the company’s market success is its R&D department, a team continually working on the expansion of advanced formulas, as well as new pharmaceutical technologies.

Softigel by Procaps annually develops more than 50 new veterinary, cosmetics, nutritional and pharmaceutical products, based on industry trends across the world.

Quality certifications

Softigel by Procaps holds quality certifications from numerous entities, including:

• Organic Certified gummies facility
• Cofepris in Mexico
• HALAL-certified gelatine
• Colombian Agriculture Institute (ICA)
• Ministry of Health (MOH) in Iran
• The US Food and Drug Administration (FDA)
• FDA Philippines
• Brazilian Health Regulatory Agency (ANVISA)
• The National Administration of Medicines, Food and Medical Technology (ANMAT) of Argentina
• GMP
• International Standardisation of Organisation (ISO) 9001
• Health Canada
• Therapeutic Goods Administration (TGA) in Australia
• EU GMP from the Medicines and Healthcare Products Regulatory Agency (MHRA)