Business Details
27 Years
experience
Your Trusted Pharmaceutical Manufacturing Partner in Farmingdale, NY
Syntho Pharmaceuticals was founded in 1999 by Muhammed and Hosneara Malik, a husband-and-wife team with decades of combined experience in pharmaceutical development and quality assurance. As an FDA-registered, DEA-licensed manufacturer, we specialize in producing high-quality branded and generic pharmaceuticals across therapeutic areas, adhering to rigorous regulatory standards including GLP, GMP, and CFR 21. Our family-run business combines scientific expertise with operational efficiency, offering end-to-end solutions from R&D to packaging for solid oral dosage forms and over-the-counter products.With a dedicated quality control team and state-of-the-art analytical lab, we ensure precision in every batch while maintaining transparency and accountability in client relationships. Our leadership team, including Director of Operations Tithi Malik, brings generational knowledge and a commitment to innovation, continuously expanding capabilities such as serialization for prescription products. Rooted in a legacy of integrity since 1999, we prioritize client collaboration and market responsiveness, serving as a trusted partner for pharmaceutical manufacturing needs.
Services
Pharmaceutical Manufacturing
Quality Control Testing
Regulatory Compliance
Product Development
Packaging Solutions
Details
- Year established: 1999
Highlights and features
- We offer 25+ years of combined leadership experience in pharmaceutical R&D and quality assurance.
- Our FDA-registered, DEA-licensed facility ensures strict compliance with GLP, GMP, and CFR 21 standards.
- We provide end-to-end manufacturing solutions from prototyping to commercialization.
- Our in-house analytical lab enables rigorous quality control testing at every production stage.
- We maintain transparent communication and collaborative partnerships with clients.
Associations and certifications
- FDA
- DEA Schedule CIIICV
Services
Pharmaceutical Manufacturing
Syntho Pharmaceuticals manufactures high-quality solid oral dosage medications, including prescription drugs, OTC products, and supplements. Our FDA-registered facility follows strict GMP guidelines to ensure safety and efficacy. We specialize in hormone replacement therapies and combination medications.
Quality Control Testing
Our in-house analytical lab performs rigorous testing of raw materials and finished products using advanced instrumentation. We validate methods and maintain compliance with GLP standards to guarantee batch consistency and regulatory adherence.
Regulatory Compliance
We ensure full compliance with FDA, DEA, and CFR 21 regulations through documented quality systems and audit-ready processes. Our team manages submissions, inspections, and ongoing compliance for domestic and international markets.
Product Development
From formulation to scale-up, we develop proprietary blends and combination therapies. Our expertise includes stability testing, method validation, and commercialization strategies for new pharmaceutical products.
Packaging Solutions
We offer packaging for solid oral dosage forms, including serialization capabilities for prescription products. Our services ensure product integrity, regulatory compliance, and market-ready presentation for clients.
People
Muhammed Malik
Founder
A pharmacist with decades of R&D and operational expertise, Muhammed founded Syntho in 1999. His leadership established the company's foundation in quality-driven pharmaceutical manufacturing and regulatory compliance.
Hosneara Malik
President and Director of Quality Assurance
With over 30 years in QA and regulatory affairs, Hosneara oversees manufacturing operations and client relationships. Her expertise ensures adherence to global quality standards and operational excellence.
Tithi Malik
Director of Operations
Tithi manages daily operations, FDA communications, and business expansion. Her technical background in quality control and regulatory affairs continues her family's legacy of pharmaceutical innovation.
Questions
What types of pharmaceutical products does Syntho manufacture?
We specialize in solid oral dosage forms, including prescription medications, over-the-counter products, supplements, and vitamins, with expanding capabilities in serialized prescription packaging.
Is Syntho Pharmaceuticalss FDA-registered and DEA-compliant?
Yes, we are FDA-registered and hold DEA Schedule CIII–CV licenses, ensuring all operations meet federal regulatory standards.
Can Syntho assist with custom pharmaceutical development?
Yes, our R&D team collaborates on formulation development, scale-up, and commercialization of proprietary blends and combination therapies.
What quality control measures are in place?
We conduct in-house testing using advanced analytical instruments, following GLP and GMP protocols at every production stage to guarantee product integrity.
How does Syntho support client partnerships?
We prioritize transparent communication, tailored solutions, and end-to-end collaboration from initial concept to final product delivery.
What is Syntho's experience in the pharmaceutical industry?
Founded in 1999, our leadership team has over 60 years of combined experience in pharmaceutical manufacturing, quality assurance, and regulatory compliance.
