Business Details
Trusted Generic Pharmaceutical Manufacturer in New York
At Chartwell Pharmaceuticals, we combine deep scientific expertise with strategic business acumen to deliver high-quality generic prescription pharmaceuticals. With decades of industry experience, we specialize in formulation trials, clinical supplies, and full-scale commercial production across four state-of-the-art manufacturing campuses in the New York metropolitan area. Our commitment to cGMP compliance and cutting-edge technology ensures reliable, consistent product quality that meets evolving market demands. We pride ourselves on maintaining long-term partnerships and offering TAA- and BAA-compliant products through our Chartwell RX label, which includes over 1,100 FDA-Approved Orange Book listings.Our focus on innovation extends to expanding capabilities in injectable forms and novel development, supported by a robust pipeline of 505(b)(2) products. With surge capacity and extended dating programs, we provide tailored solutions for government contracts while prioritizing Made-in-the-USA reliability. Our leadership teams collective expertise in manufacturing, regulatory affairs, and commercial operations drives continuous improvement in addressing customer needs and industry challenges.
Services
Generic Pharmaceutical Manufacturing
FDA-Approved Products
TAA/BAA Compliance
Product Pipeline Development
cGMP Compliant Facilities
Highlights and features
- We have decades of pharmaceutical industry experience from formulation to commercial batches.
- Our pristine facilities are fully cGMP compliant with sophisticated technologies.
- We offer over 1,100 FDA-Approved Orange Book listings.
- We provide Trade Agreements Act (TAA) and Buy American Act (BAA) compliant products.
- Our leadership team has over 20 years of combined experience in generic pharmaceuticals.
Services
Generic Pharmaceutical Manufacturing
Chartwell specializes in manufacturing high-quality generic prescription medications across diverse dosage forms, including tablets, capsules, solutions, and injectables. Our cGMP-compliant facilities utilize advanced technologies to ensure consistent product quality and regulatory compliance. With over 1,100 FDA-approved products, we support both commercial and government clients through reliable, on-time delivery.
FDA-Approved Products
We maintain over 1,100 FDA-Approved Orange Book listings, ensuring our products meet rigorous regulatory standards. Our expertise spans formulation development, ANDA submissions, and site transfers, supported by a leadership team with decades of experience in navigating complex compliance requirements for generic pharmaceuticals.
TAA/BAA Compliance
Chartwell provides Trade Agreements Act (TAA) and Buy American Act (BAA) compliant products tailored for government procurement. Our surge production capacity and extended dating programs maximize investment efficiency for state and federal contracts while maintaining Made-in-the-USA reliability.
Product Pipeline Development
Our robust pipeline includes over 1,100 Orange Book listings and ongoing development of 505(b)(2) products. With recent acquisitions and expanded capabilities in novel dosage forms, we offer accelerated ANDA manufacturing and strategic partnerships to address evolving market demands.
cGMP Compliant Facilities
Our four New York-based manufacturing campuses adhere to current Good Manufacturing Practices (cGMP), ensuring quality control across all production stages. With dedicated quality assurance leadership and ISO-standard processes, we maintain pristine facilities that meet the highest industry regulatory requirements.
People
Jack Goldenberg
Managing Member
Jack Goldenberg leads Chartwell Pharmaceuticals with strategic vision, leveraging decades of experience in the generic pharmaceutical industry to drive operational excellence and long-term partnerships.
Lance Kann
Senior Executive Vice President Corporate Development and Strategy
Lance Kann brings 45 years of global pharmaceutical experience, including leadership roles at Teva, Mylan, and Pfizer, specializing in corporate development, supply chain optimization, and innovative business strategies.
Kerry Collias
Executive Vice President Sales and Marketing
Kerry Collias has 35 years of expertise in generic pharmaceutical sales and marketing, with a proven track record in business development, national account management, and successful product launches.
Kiran Kanneganti
Senior Vice President, Head of R&D and Technical Services
Kiran Kanneganti leads R&D initiatives with 24+ years of experience, overseeing the development of 120+ ANDAs and advancing cost-effective medication solutions through innovative process improvements.
Monique Weitz
Executive Vice President Regulatory Affairs
Monique Weitz directs regulatory compliance with 25 years of experience, holding certifications in Regulatory Affairs (RAC) and Project Management, ensuring adherence to FDA and international standards.
Questions
What types of pharmaceutical products does Chartwell offer?
Chartwell offers over 1,100 FDA-approved generic medications in dosage forms including tablets, capsules, solutions, suspensions, semi-solids, ophthalmics, otics, and injectables.
Are Chartwell's products compliant with government procurement requirements?
Yes, our Chartwell RX label includes Trade Agreements Act (TAA) and Buy American Act (BAA) compliant products for government contracts.
Where are Chartwell's manufacturing facilities located?
Our four main manufacturing campuses operate in the New York metropolitan area, with additional locations in Amityville and Carmel, NY.
Does Chartwell offer custom packaging solutions?
Yes, we provide traditional and custom packaging solutions tailored to client needs for both commercial and government contracts.
