Therapeutic Area
Cardiovascular CDMOs
Compare CDMOs with cardiovascular drug manufacturing expertise for antihypertensives, anticoagulants, antiarrhythmics, and lipid-lowering therapies. Filter by dosage form, scale, and regulatory approvals.
171 companies listed
About Cardiovascular Drug Manufacturing
Cardiovascular drugs represent one of the largest established therapeutic segments, with a mature generics market and growing biologics pipeline. Manufacturing spans small molecule APIs (statins, ACE inhibitors, beta-blockers, calcium channel blockers), controlled-release oral solid dosage forms, and an expanding portfolio of injectable biologics (PCSK9 inhibitors, anti-inflammatory antibodies for atherosclerosis).
Formulation complexity is increasing. Many cardiovascular drugs require modified-release profiles to maintain therapeutic levels over 24 hours with once-daily dosing. Fixed-dose combinations (e.g., statin + antihypertensive) add formulation challenges around drug-drug compatibility, stability, and dissolution profile matching. CDMOs with strong oral solid dose and coating capabilities are well positioned.
Scale matters in this segment. Cardiovascular drugs often reach blockbuster commercial volumes -- hundreds of millions of doses per year. CDMOs need high-throughput tableting lines, efficient coating systems, and robust supply chain management to handle these volumes reliably. Ask about batch success rates and on-time delivery metrics for commercial-scale programs.
Companies (171)
UPM Pharmaceuticals
United States
UPM Pharmaceuticals is a U.S.-based CDMO specializing in late-stage commercial manufacturing of semi-solid and oral solid dose products. Operating from a 475,000 sq ft cGMP FDA-registered facility in Bristol, Tennessee, UPM is a family-owned company with 30+ years of experience. They handle DEA-controlled substances and provide services from technology transfer and scale-up through commercial manufacturing. Capabilities include formulation development, analytical development, coated tablet manufacturing, pharmaceutical serialization, aggregation, and full packaging and warehousing.
Small Molecule Drug ProductOral Solid DoseFormulation Development
PeptiStar Inc.
Japan
PeptiStar is a Japan-based CDMO specializing in the development and cGMP manufacture of peptide and oligonucleotide APIs. From its 10,500 m² R&D and manufacturing site in Settsu, Osaka, the company supports programs from milligram-scale research material through clinical and commercial production. PeptiStar works with complex peptide structures, including long-chain, cyclic, branched and constrained peptides, non-natural amino acids and peptide conjugates. Its route-flexible manufacturing platform includes conventional and microwave-assisted SPPS, STag-PS and SYNCSOL liquid-phase technologies. Integrated downstream capabilities include preparative and continuous chromatography, membrane concentration and lyophilization, with 300 L filter reactors, chromatography columns up to 450 mm and lyophilizers up to 500 L. Purification and subsequent processing are conducted in Class 100,000 controlled areas. PeptiStar also develops and manufactures oligonucleotide APIs and peptide–oligonucleotide conjugates. The company was recognised by Exelixis as its 2025 CDMO of the Year.
Frequently Asked Questions
What formulation expertise matters for cardiovascular CDMOs?+
Modified-release technology is critical. Many cardiovascular drugs require extended-release or controlled-release formulations for once-daily dosing compliance. CDMOs should demonstrate expertise in matrix tablets, osmotic systems, multi-particulate systems (pellets in capsules), and film-coating technologies. Fixed-dose combination experience is increasingly important as combination therapies become standard of care.
What regulatory considerations apply to cardiovascular drug manufacturing?+
Cardiovascular drugs are among the most widely prescribed globally, so regulatory expectations for manufacturing consistency are high. Process validation requirements are stringent given the large patient populations at risk. Bioequivalence studies for generic versions require careful formulation matching. For novel biologics (PCSK9 inhibitors, siRNA therapies), the regulatory pathway follows BLA/MAA requirements with full CMC dossiers.
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