Softgels are an effective delivery system for oral drugs products, especially those with low-solubility and permeability (BCS classes II, III and IV).
Softigel by Procaps is a leading supplier of contract development and manufacturing services in softgel advanced technologies for pharmaceutical companies across the world.
The company assists in helping various businesses bring innovative products to market faster through its extensive capabilities and deep expertise in product development and softgel manufacturing. Softigel by Procaps offers consumers and patients super adherence, exceptional experience, and higher preference to alternative therapies.
To become an integrated contract development and manufacturing organisation (iCDMO), Softigel by Procaps combined its advanced delivery technologies with proven regulatory, formulation and manufacturing expertise. The company provides its clients with full-service, turnkey solutions in prescription medications, over-the-counter (OTC) and dietary supplements across both development and distribution.
Contract development and manufacturing services for the pharmaceutical industry
Softigel by Procaps specialises in challenging-to-manufacture drugs, geared to identifying and developing business opportunities in both generic and highly regulated markets, particularly in niche divisions where there is inadequate competition.
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
- Prefilled syringes
- 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.
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
- 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)
Softigel’s seven cutting-edge facilities house a fully integrated product development services (PDS) unit, which covers a wide range of product lifecycle phases from early development to commercialisation in the same plant, using equipment replication from lab scale, through small-scale good manufacturing practice (GMP) batches, until full-scale commercial GMP.
At Softigel we believe in transformation, in expanding our reach and we are doing this by breaking the wall between the virtual and the physical world.
The present is an overview of the state-of-the-art for vegetarian soft capsules in terms of materials (sourcing and demand), applications, processing, products and a general insight of the current state of materials and technology of these gelatin alternatives.
Cannabis-based products are manufactured, mainly, from oils obtained from a synthetic way as Dronabinol or obtained from plants of genus Cannabis, as Cannabidiol (CBD) oils.
In recent years, the development of highly potent molecules has become more frequent, and around 25% of the components that are being developed are classified as potent.
Softigel by Procaps, a leading provider of contract development and manufacturing services in softgel advanced technologies for the pharmaceutical and nutraceutical industries, is proud to announce the launch of its newly revamped website.
Procaps has become the first company nationwide to be recognised as a Highly Innovative Company due to the strength of the processes of research, development and innovation, rigorously evaluated by the Colombian Ministry of Science.
Softigel® by Procaps is continuously working on creating the right product for your patients/customers.
Nutrition is a trending topic for consumers today, but taste, convenience and ease-of-use are also influencing purchasing decisions.
Softigel has announced it will be showcasing its products at Vitafoods Europe, Switzerland.
Softigel by Procaps will be attending CPhi North America´s second edition once again.
Softigel by Procaps will be exhibiting at CPhI Worldwide.
Softigel by Procaps will be attending CPhI Worldwide in Paris from 7-9 October, where our team of experts will be available to discuss mutual opportunities.
Calle 80 # 78B – 201
Av. Patriotismo N° 229 Piso 7Ofic. N° 206
Col. San Pedro De Los Pinos
Deg. Benito Juarez
Maipú 1210 Piso 8, oficina 817, C1006
Estrada dos Estudantes, 349
1815 Griffin Road, Suite 404
United States of America