Ecron Acunova

Ecron Acunova

Bioavailability and bioequivalence (BABE) studies for generic drug approval, including complex generics, biosimilars, and inhalation studies.

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DateInvestorsAmountRound

$19.0m

Valuation: $19.0m

Acquisition
Total Funding000k
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Ecron Acunova operates as a clinical research organization (CRO) with a specialization in bioavailability and bioequivalence (BABE) studies. These studies are a mandatory requirement for pharmaceutical companies seeking regulatory approval from health authorities, such as the US FDA, to market generic drugs.

The firm's service portfolio is designed to support Abbreviated New Drug Applications (ANDA) under pathways like 505(j) or 505(b)(2). Its capabilities cover a range of generic drug types, from immediate and modified release formulations to more complex generics. Ecron Acunova also conducts patient-based and clinical endpoint bioequivalence studies, as well as specialized research including euglycemic clamp and inhalation studies, with noted experience in biosimilar insulin.

The business model is service-based, generating revenue by conducting these critical clinical trials for pharmaceutical clients aiming to be first-to-market with their generic products. The organization emphasizes regulatory compliance, adhering to Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). Its facilities have undergone 40 successful regulatory audits, and its laboratories hold NABL and CAP certifications, underscoring its position in the CRO market.

Keywords: clinical research organization, bioavailability, bioequivalence, generic drugs, drug approval, US FDA, ANDA, biosimilars, clinical trials, regulatory compliance

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