At Abiozen, we specialize in the development and sterile manufacturing of hormonal and specialty injectable APIs, meeting the complex demands of modern therapeutic regimens. Leveraging advanced synthesis technologies and aseptic processing, we deliver high-quality APIs tailored to niche therapeutic needs, drawing on proven frameworks inspired by global leaders like Curia Global.

Peptide-Based Therapies

We produce complex peptide APIs such as insulin analogs and somatostatin derivatives through both solid-phase and solution-phase synthesis. High-efficiency resins and innovative coupling agents are utilized to achieve maximum yield and purity. Preparative high-performance liquid chromatography (HPLC) ensures the removal of trace impurities, supporting injectables with stringent potency, consistency, and bioavailability requirements.

Hormonal Treatment APIs

Our hormonal API portfolio includes testosterone, estrogen, and thyroid hormones, all manufactured with precision using advanced particle engineering techniques such as micronization and nanomilling. For steroidal APIs, we ensure control over polymorphic forms via differential scanning calorimetry (DSC) and X-ray diffraction (XRD), guaranteeing formulation stability and batch-to-batch uniformity.

Specialty Injectables for Rare Diseases

For rare and orphan disease applications—including cystic fibrosis and hemophilia—we produce small-volume, high-value APIs under strict containment. Our approach includes lipid-based delivery systems and nanoparticle encapsulation to improve solubility and targeting. These high-performance formulations are developed under occupational exposure limits (OELs) to ensure both safety and therapeutic efficacy.

Quality Assurance and Regulatory Compliance

Abiozen implements rigorous quality standards aligned with USP, EP, and JP monographs. Each injectable product undergoes extensive analytical testing, including HPLC for purity, mass spectrometry (MS) for molecular identification, endotoxin testing (LAL assay) for safety, and laser diffraction for particle size analysis. Our global compliance framework supports regulatory submissions to USFDA, EMA, and PMDA, enabling successful entry into international markets.