Business Details
27 Years
experience
Your Trusted Partner for Pharmaceutical Manufacturing Solutions
Syntho Pharmaceuticals is a family-owned business established in 1999, dedicated to developing and manufacturing high-quality branded and generic pharmaceuticals. Our expertise spans therapeutic areas, regulatory compliance, and operational efficiency, ensuring clients receive reliable products. Founded by Muhammed and Hosneara Malik, our leadership combines decades of pharmaceutical experience with a commitment to innovation. We maintain FDA registration and DEA licensing, adhering to rigorous quality standards in manufacturing and packaging. Our team operates a fully equipped analytical lab, following GLP, GMP, and CFR 21 guidelines to guarantee product integrity.We specialize in solid oral dosage forms and offer packaging solutions for supplements, vitamins, and OTC products. Our focus on continuous improvement drives our efforts to expand serialization capabilities for prescription medications. With a client-centric approach, we prioritize accountability, transparency, and timely delivery of market-responsive solutions. Our legacy of excellence is built on a foundation of family values and industry leadership. We invite partners to collaborate with us to address evolving pharmaceutical needs while upholding our reputation for quality and reliability.
Services
Pharmaceutical Manufacturing
Packaging Services
Quality Control
Regulatory Compliance
Product Development
Details
- Year established: 1999
Highlights and features
- We are a family-run business with 24 years of pharmaceutical industry experience.
- Our FDA registration and DEA licensing ensure regulatory compliance.
- We operate a fully equipped analytical lab for rigorous quality control.
- Our team delivers efficient, market-responsive manufacturing solutions.
- We uphold accountability for product integrity from development to delivery.
Associations and certifications
- FDA
- DEA
Services
Pharmaceutical Manufacturing
We specialize in manufacturing solid oral dosage pharmaceuticals, adhering to FDA and DEA regulations. Our process includes formulation development, scale-up, and commercialization of high-quality medications. Clients benefit from our expertise in therapeutic areas and commitment to timely market delivery.
Packaging Services
Our packaging solutions cover solid oral dose supplements, vitamins, and OTC products. We implement serialization for prescription medications to meet evolving regulatory requirements. Clients receive reliable, compliant packaging tailored to their product specifications and market needs.
Quality Control
Our analytical lab conducts rigorous testing of raw materials and finished products using advanced instruments. We follow GLP and GMP standards to ensure compliance with CFR 21 regulations. Clients gain confidence in product consistency and safety through our continuous quality assurance processes.
Regulatory Compliance
We maintain FDA registration and DEA licensing, ensuring all operations meet federal guidelines. Our team manages regulatory submissions and compliance documentation. Clients receive expert guidance to navigate complex regulatory landscapes efficiently and avoid delays.
Product Development
Our R&D team develops innovative formulations and optimizes production methods for scalability. We focus on creating solutions for post-menopausal therapies and respiratory treatments. Clients partner with us to bring cutting-edge, market-ready products to consumers through collaborative research.
People
Muhammed Malik
Founder
A pharmacist with decades of R&D and operational expertise, Muhammed founded Syntho in 1999. His leadership in regulatory compliance and quality control established the company's foundation for growth and industry success.
Hosneara Malik
President
With over 30 years in quality assurance, Hosneara oversees manufacturing and regulatory operations. Her expertise ensures compliance with industry standards, making her instrumental in Syntho's reputation for reliable pharmaceutical production.
Tithi Malik
Director of Operations
Tithi manages daily operations and regulatory communications, leveraging her background in quality control and business expansion. She continues her family's legacy by driving Syntho's growth through strategic outreach and operational excellence.
Questions
What pharmaceutical services does Syntho offer?
We provide manufacturing, packaging, and quality control for solid oral dosage medications, including prescription drugs, OTC products, and supplements.
Are Syntho's products FDA approved?
Yes, we are FDA-registered and follow DEA licensing requirements for controlled substances in schedules CIII-CV.
How does Syntho ensure product quality?
Our lab conducts rigorous testing under GLP and GMP standards, using advanced equipment to verify raw materials and finished products.
Can Syntho handle custom pharmaceutical projects?
Yes, we collaborate on formulation development and scale-up for unique therapeutic needs, including hormone replacement and respiratory treatments.
