Contract Development Services and Drug Delivery Systems
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Softigel is Procaps' strategic business unit for contract development services. The company supports healthcare and related businesses that develop, manufacture and commercialise pharmaceutical products.
Softgel capsules for the drug development industry
Softgel capsules are produced in Barranquilla, Colombia, as well as nutritional supplements, veterinary and cosmetics in soft gelatin capsules and advanced delivery technologies.
The company has facilities in Brazil, Colombia and Venezuela.
With manufacturing sites in South Africa, Softigel offers various pharmaceutical dosage forms, shapes, and colours, in small to large-scale batches for 38 different countries worldwide.
Softigel focuses on difficult-to-manufacture drugs and aims to capitalise on business opportunities in generic and highly regulated pharmaceutical markets, especially in niche segments with limited competition.
Strong analytical support and expertise in new molecular entities (NMEs) for highly regulated markets are also available. The company houses a fully integrated product development services (PDS) unit.
Drug dosage systems
Softigel offers access to delivery systems such as Unigel, a novel technology for fixed dose combinations and Versagels, which provides a new approach to soft capsules without animal derivatives.
Other products include G-Tabs gelatin coated tablets, twist-off capsules, nutritional gummies, omega-3 high concentrates, tablets, powders, creams, ointments, gels and hard gel capsules.
The company provides pharmaceutical regulatory support and value-added marketing services, and all plants fully comply with current good manufacturing practices (cGMP).
The softgel facility is approved by US Food and Drug Administration (FDA) and Medicine and Healthcare Products Regulatory Agency (MHRA). Softigel delivers services to a range of pharmaceutical clients, including Pfizer, Sanofi, Boehringer Ingelheim and Bayer.
Manufacturing of pilot batches for softgels and tablets
The manufacturing facilities cover product lifecycle phases from early development to commercial, and offer single and multiple drug dosage systems.
Procaps' pilot plant facility for the manufacturing of experimental and pilot batches for softgels, liquids and tablets, uses equipment that can replicate lab-scale and small-scale non-good manufacturing practices (GMP) and GMP batches, up to full-scale commercial GMP.
Clinical trial manufacturing
The product development team provides clients with access to formulation and processing clinical trial manufacturing, scale-up, analytical development and regulatory support for markets that include the US, Europe and LATAM.
The company assists clients from Phase I, through to registration and large scale commercial production.
Softgel dosage forms have a range of benefits, including:
- Enhanced bioavailability for low solubility / low permeability compounds
- Life cycle management extension for drug products
- Low dose and high potency compounds
- Uniformity of dosage
- Lipid formulations, including improved, self-emulsifying API formulations
Available White Papers
Go Beyond With Your Discoveries with Softigel Product Development and Contract Manufacturing Services Part of the Procaps Group and one of the world's largest manufacturers, Softigel shows its deep knowledge of gelatin formation in its softgels expertise.
Stability Issues Related to Soft Gelatin Capsule Development Stability issues are a challenge for formulators. The reactivity of formulations depends on many factors, although it is generally recognised that labile drugs in aqueous forms are sometimes the worst cases.