Business Details
19 Years
experience
Trusted Generic Drug Manufacturer in the U.S.
Sunrise Pharmaceutical, Inc. has dedicated itself to revolutionizing access to essential medications through high-quality, affordable generic drugs. Since our founding, we have prioritized innovation, compliance, and patient-centric values, establishing ourselves as a trusted partner in the pharmaceutical industry. Our journey began with a vision to address critical healthcare needs by delivering safe, effective treatments to millions of patients nationwide. Over the years, we have expanded our product pipeline, strengthened our regulatory compliance, and built a team of experts committed to excellence. Our leadership in generic drug development is rooted in decades of combined experience, advanced manufacturing technologies, and adherence to the strictest quality standards. Every product we produce reflects our unwavering commitment to cGMP guidelines, ensuring consistency, safety, and efficacy across all therapeutic areas.We collaborate with local and national retailers, wholesalers, and health systems to ensure broad market accessibility. Our corporate philosophy emphasizes continuous improvement, customer satisfaction, and ethical responsibility, fostering long-term partnerships and a positive work environment. With a state-of-the-art facility in the U.S. and a distribution network spanning the nation, we remain focused on exceeding industry benchmarks. Our teams expertise in regulatory affairs, analytical chemistry, and quality assurance positions us at the forefront of generic pharmaceutical innovation, driving our mission to enhance public health through accessible care.
Services
Generic Drug Manufacturing
Quality Assurance
Regulatory Compliance
Pharmaceutical Distribution
R&D Services
Details
- Year established: 2007
Highlights and features
- We adhere to FDA, DEA, and cGMP compliance for all products.
- Our team includes experts in regulatory affairs and quality assurance.
- We utilize state-of-the-art manufacturing technologies.
- We offer a diverse portfolio of generic medications.
- Our distribution network serves the entire United States.
Services
Generic Drug Manufacturing
We produce oral solid dose generics, including tablets, capsules, and powders, using advanced manufacturing technologies. Our processes ensure compliance with FDA, DEA, and cGMP standards, guaranteeing safety, efficacy, and affordability for patients nationwide.
Quality Assurance
Our quality systems include routine internal audits and external inspections to maintain cGMP compliance. Every product undergoes rigorous testing to meet or exceed regulatory standards, ensuring consistency and reliability for healthcare providers and consumers.
Regulatory Compliance
We specialize in ANDA filings and adhere to U.S. regulatory requirements, including FDA, DEA, EPA, and OSHA guidelines. Our team ensures all products meet bioequivalence and quality benchmarks for market approval and distribution.
Pharmaceutical Distribution
Our Ohio-based distribution center spans 260,000 square feet, enabling efficient nationwide delivery. We partner with retailers, wholesalers, and health systems to ensure timely access to generic medications across therapeutic categories.
R&D Services
We focus on developing a robust pipeline of generic drugs, leveraging scientific expertise to address unmet medical needs. Our R&D efforts prioritize innovation, regulatory readiness, and scalable manufacturing solutions for long-term market viability.
Questions
What does Sunrise Pharmaceutical specialize in?
We specialize in developing and manufacturing high-quality, affordable generic medications in oral solid dose forms, including tablets, capsules, and powders.
Are Sunrise's products FDA-approved?
Yes, all products comply with FDA regulations and cGMP standards, ensuring safety, efficacy, and bioequivalence to brand-name counterparts.
How does Sunrise ensure product quality?
We conduct rigorous internal audits, external inspections, and adhere to cGMP guidelines to maintain compliance with FDA, DEA, and OSHA standards.
Where are Sunrise's products distributed?
Our products are distributed nationwide through retailers, wholesalers, health systems, and government channels via our Ohio-based distribution center.
When was Sunrise Pharmaceutical founded?
Sunrise was founded in 2007 and has since grown into a leading generic drug manufacturer with a focus on innovation and quality.
