Business Details
Chartwell Pharmaceuticals: Trusted Generic Medication Manufacturer
Chartwell Pharmaceuticals operates four state-of-the-art manufacturing and analytical campuses in the New York metropolitan area, specializing in high-quality generic prescription pharmaceuticals. With decades of industry experience spanning formulation trials to full-scale commercial production, we deliver reliable, consistent products across diverse dosage forms including tablets, capsules, solutions, suspensions, and soon injectables. Our cGMP-compliant facilities utilize advanced technologies to meet evolving market demands, supported by over 1,100 FDA-approved Orange Book listings.We prioritize TAA and BAA compliance, ensuring Made-in-the-USA quality for government and commercial clients. Our leadership team combines over 20 years of hands-on experience in manufacturing, R&D, and regulatory affairs, driving innovation while maintaining rigorous quality standards. With a robust pipeline of 505(b)(2) products and anticipated launches, we continuously expand capabilities to address critical healthcare needs. Our surge capacity and extended dating programs optimize production efficiency, reinforcing our commitment to timely delivery and client partnership.
Services
Pharmaceutical Manufacturing
Generic Drug Development
ANDA Manufacturing
Product Acquisitions
Government Contract Supply
Injectable Formulations
Solid Dosage Production
Ophthalmic Solutions
OTC Product Development
Regulatory Compliance
Highlights and features
- We offer over 1,100 FDA-approved generic pharmaceutical products with TAA/BAA compliance.
- Our cGMP-compliant facilities utilize advanced technologies for rigorous quality control.
- Leadership team combines 20+ years of hands-on experience in pharmaceutical manufacturing.
- Robust pipeline includes 505(b)(2) products and 20+ anticipated launches in 9 months.
- Surge capacity and extended dating programs optimize production efficiency for clients.
Services
Pharmaceutical Manufacturing
Chartwell produces high-quality generic medications across diverse dosage forms including tablets, capsules, solutions, and suspensions. Our cGMP-compliant facilities utilize advanced technologies to ensure consistency and regulatory compliance. With over 1,100 FDA-approved products, we serve commercial and government clients requiring Made-in-the-USA pharmaceuticals.
ANDA Manufacturing
We specialize in Abbreviated New Drug Application (ANDA) manufacturing, developing cost-effective generic alternatives with expertise in site transfers and complex formulations. Our team has successfully developed over 120 ANDAs, including first-to-file generics, ensuring regulatory compliance and market readiness.
Government Contract Supply
Chartwell provides TAA and Buy American Act compliant pharmaceuticals for federal and state contracts. Our surge capacity and extended dating programs optimize production timelines and investment efficiency for government clients requiring reliable medication supplies.
Product Acquisitions
We actively seek product acquisitions to expand our portfolio, offering strategic partnerships for assets no longer aligned with seller priorities. Our team evaluates opportunities to integrate products into our manufacturing pipeline, enhancing market availability and client value.
Regulatory Compliance
Our regulatory affairs and quality assurance teams ensure adherence to FDA, cGMP, and ISO standards. With certified professionals managing inspections, audits, and risk management, we maintain pristine facilities and robust systems for consistent product quality and compliance.
People
Jack Goldenberg
Managing Member
Over 20 years of leadership in pharmaceutical manufacturing and distribution, driving strategic growth and operational excellence across Chartwell's facilities.
Lance Kann
Senior Executive Vice President
45-year industry veteran with expertise in corporate development and global operations, having held leadership roles at Teva, Mylan, and Pfizer.
Kerry Collias
Executive Vice President
35 years in generic pharmaceutical sales and marketing, specializing in business development and commercial operations for national accounts and government contracts.
Kiran Kanneganti
Senior Vice President R&D
24 years of experience leading ANDA development and site transfers, with over 120 successful generic product launches and technical innovations.
Monique Weitz
Executive Vice President
25-year regulatory affairs leader with expertise in FDA compliance, holding RAC and PMP certifications to ensure quality and regulatory success.
Questions
What products does Chartwell Pharmaceuticals offer?
We manufacture over 1,100 FDA-approved generic prescription medications in tablets, capsules, solutions, suspensions, and soon injectables, with TAA/BAA compliance.
Does Chartwell work with government entities?
Yes, we specialize in Trade Agreements Act and Buy American Act compliant products with surge capacity for federal/state contracts.
How does Chartwell ensure product quality?
Our cGMP-compliant facilities use advanced technologies and rigorous quality systems overseen by experienced regulatory and QA teams.
What is Chartwell's product development focus?
We prioritize expanding dosage forms, 505(b)(2) products, and ANDA manufacturing with 20+ anticipated launches in the next 9 months.
