Conception to Commercial Launch
A Company Designed to Develop High Barriers to Market Products and Long term Partnerships.
Our Services
Cerovene is your ideal strategic partner for Product development / pharmaceutical dosage form development / Patent development / clinical & commercial manufacturing.
Cerovene offers comprehensive service capabilities, from product concept development to market launch such as:
- R&D and manufacturing of High Potency Products.
- Pre-Formulation: characterization of drug substances and excipients
- Formulation and product feasibility.
- Formulation development and optimization.
- Controlled substances (Schedule II, III).
- Engineering product formulations/process to fit client facilities/equipment.
- Technology transfer.
- Scale-up manufacturing and process validation support.
- Test methods development and validation for active drug substances and finished products.
- Interfacing with CROS for bioequivalence and clinical studies.
- FDA pre-approval and pre-market validation support.
- Developing regulatory and compliance strategies to optimize success of drug approval by the FDA.
- Consultation on building R&D Teams and Facilities.
Cerovene Technologies
Cerovene has proprietary drug-coated capsule technology which provides many benefits.
Product life cycle Extensions.
Manufacturing uses conventional processes.
Increase in bioavailability for poorly soluble drugs.
Reduce product strength for fewer side effects and while demonstrating the same efficacy.
Suitable for incompatible drugs within Fixed Dose Combination (FDC) product.
Cerovene’s proprietary technologies make it possible to develop new formulations and dosage forms of existing chemical molecules which increase patent and product life.
Cerovene is recognized as a successful company with expertise in a broad range of Drug Delivery Technologies such as:
· Pulse Release.
· Delayed Release & Sustained Release.
· Extended Release.
· Sustained zero-order Release.
· Matrix-hydrogel Controlled Released.
· Enteric Coated.
· Tablet in Capsule.
· Coated Capsules.
Pipeline
Our programs are grounded in rational science and strategies to identify API suppliers, Brand acquisition, difficulties in drug development, pivotal study requirements, Endpoint study requirements, Patent landscape and invalidation, FDA exclusivity timing, Para IV challenges, and targeted therapies that have future high value for generic applications.
About Us
CEROVENE is staffed with talented and competent team of scientists and technicians, who have completed and are capable of timely FDA approvals for most complex products, along with a distinguished team of scientific, regulatory and legal experts.
Manish S. Shah
M.S., R.Ph.
Founder, President and Director
- Over 25 years of Pharmaceutical Research & Development experience in the areas of Formulation, Validation, Analytical, Manufacturing and Regulation of the drugs & drug Products.
- Successfully developed and received US FDA approvals of more than 90 Rx products both immediate & extended-release and over 30 OTC products.
- B.S. in Pharmacy from Poona University and M.S. in Industrial Pharmacy from Arnold & Marie Schwartz College Of Pharmacy, New York.
- Inventor/co-inventor of various products and patents.
- Registered Pharmacist in the State of New York & New Jersey.
Ray DiFalco
Founder, Vice President
and Director
- More than 25 years of experience in the Pharmaceutical Industry working for Generic as well as Branded Companies.
- Extensive experience in Bulk and Finished product.
- Focus on Finished product manufacturing of solid, semi-solid and liquid. pharmaceutical dosage forms with responsibilities ranging from Facility design to Finished Manufacturing
- Manufacturing with an Engineering background in facility construction, equipment installation, and facility/equipment validation, as well as process validation.
- Mr. DiFalco has B.S. in Chemical Engineering and B.S. in Business Administration from Manhattan College and New York University. Inventor/co-inventor of various products and patents.
Are you looking for comprehensive partnership opportunities?
Our Facilities
Our Objectives
Cerovene is committed to support research that will advance scientific knowledge and generate new medical outcomes for patients.
All Products are developed in our CGMP FDA/DEA approved facilities located in both our Valley Cottage Facility and newly built Orangeburg facilities. Facilities equipped with labs, analytical, R&D, Validated manufacturing/Processing technologies and equipment necessary to file ANDA’s and NDAs. Our equipment capabilities range from wet and dry granulations, pellet formulations, coating, Tri & Bi-layer tableting, fluidization, powder filling, spray drying, encapsulation, and powder filling.
Our Partners
From Conception to commercial launch, Cerovene provides a comprehensive partnership assuring our partners the proper attention to ensure detailed collaboration in working towards a timely product approvals with USFDA.
If you want to partner with us to explore how we could help you strengthen your pipeline, please contact us at General@cerovene.com
Collaborate with us
Cerovene Headquarters
If you want to partner with us to explore how we could help you strengthen your pipeline, please contact us.