Veranova
Contract development and manufacturing organization (CDMO) focused on complex small-molecule APIs and specialty modalities. Services include discovery and development, solid form and particle engineering, process and analytical development, technology transfer, multi-scale cGMP manufacturing (including highly potent APIs and controlled substances), nucleotide/oligonucleotide production, and API lifecycle management across US and UK sites.
Industries
Nr. of Employees
large (251-1000)
Veranova
Wayne, Pennsylvania, United States, North America
Products
Apomorphine hydrochloride (API)
Active pharmaceutical ingredient used as a non-selective dopamine agonist; CAS 41372-20-7. Regulatory monographs and dossiers available on request.
Naloxone hydrochloride (API)
Active pharmaceutical ingredient for opioid overdose reversal; CAS 51481-60-8. Multiple regulatory monographs and DMF/CEP filings referenced.
Cisplatin (API)
Chemotherapy active pharmaceutical ingredient used in oncology; CAS 15663-27-1. Historical manufacturing experience documented.
Nintedanib (API)
Small-molecule kinase inhibitor; CAS 656247-18-6. Specifications listed including formula and molecular weight; regulatory filings available on request.
Pirfenidone (API)
Anti-fibrotic small-molecule active pharmaceutical ingredient; CAS 53179-13-8. Regulatory filings: DMF submitted to FDA (as stated).
Apomorphine hydrochloride (API)
Active pharmaceutical ingredient used as a non-selective dopamine agonist; CAS 41372-20-7. Regulatory monographs and dossiers available on request.
Naloxone hydrochloride (API)
Active pharmaceutical ingredient for opioid overdose reversal; CAS 51481-60-8. Multiple regulatory monographs and DMF/CEP filings referenced.
Cisplatin (API)
Chemotherapy active pharmaceutical ingredient used in oncology; CAS 15663-27-1. Historical manufacturing experience documented.
Nintedanib (API)
Small-molecule kinase inhibitor; CAS 656247-18-6. Specifications listed including formula and molecular weight; regulatory filings available on request.
Pirfenidone (API)
Anti-fibrotic small-molecule active pharmaceutical ingredient; CAS 53179-13-8. Regulatory filings: DMF submitted to FDA (as stated).
Services
Integrated contract development and manufacturing services covering discovery, process and analytical development, scale-up, regulatory support and commercial API supply.
Polymorph/salt/cocrystal screening, crystallization development, spray drying, particle-size modification and solid-state analytics to support formulation and manufacturability.
Process optimization, separations and purification development, analytical method development and validation to support scale-up and regulatory submission.
Multi-scale GMP manufacture of APIs including laboratory, clinical kilo and commercial production with downstream processing and containment options for potent compounds.
Design, synthesis and manufacturing support for linkers and payloads, PROTACs, peptides, oligonucleotides, and PEG/lipid intermediates with analytical support for complex modalities.
Multi-scale oligonucleotide manufacturing by solid-phase and liquid-phase synthesis, custom monomer production and phosphoramidite supply for clinical through commercial needs.
Integrated contract development and manufacturing services covering discovery, process and analytical development, scale-up, regulatory support and commercial API supply.
Polymorph/salt/cocrystal screening, crystallization development, spray drying, particle-size modification and solid-state analytics to support formulation and manufacturability.
Process optimization, separations and purification development, analytical method development and validation to support scale-up and regulatory submission.
Multi-scale GMP manufacture of APIs including laboratory, clinical kilo and commercial production with downstream processing and containment options for potent compounds.
Design, synthesis and manufacturing support for linkers and payloads, PROTACs, peptides, oligonucleotides, and PEG/lipid intermediates with analytical support for complex modalities.
Multi-scale oligonucleotide manufacturing by solid-phase and liquid-phase synthesis, custom monomer production and phosphoramidite supply for clinical through commercial needs.
Expertise Areas
- Solid form science and particle engineering
- Process development and route optimization
- Technology transfer and scale-up
- cGMP API manufacturing and high-potency API handling
Key Technologies
- Solid-state characterization and crystallization
- Spray drying and amorphous solid dispersion
- Particle size reduction and micronization
- Solid-phase and liquid-phase oligonucleotide synthesis
News & Updates
White paper summarizing analytical techniques for characterization, stability assessment and regulatory implications for ADCs.
Expert insight article discussing bioorthogonal and click chemistries and their role in constructing complex therapeutic modalities.
Reported collaboration on a proportion of FDA-approved small-molecule drugs since 2014 (company-stated figure).
Company-stated portfolio of over 200 active Drug Master Files (DMFs).
Company-stated completion of 2,500+ solid form projects across diverse APIs.
Reported that the Devens site passed an FDA inspection with zero observations.
White paper summarizing analytical techniques for characterization, stability assessment and regulatory implications for ADCs.
Expert insight article discussing bioorthogonal and click chemistries and their role in constructing complex therapeutic modalities.
Reported collaboration on a proportion of FDA-approved small-molecule drugs since 2014 (company-stated figure).
Company-stated portfolio of over 200 active Drug Master Files (DMFs).
Company-stated completion of 2,500+ solid form projects across diverse APIs.
Reported that the Devens site passed an FDA inspection with zero observations.