Business Details
Trusted Pharmaceutical Manufacturing Services in Dupo, IL
At Sterling Pharmaceutical Services, we specialize in formulating and manufacturing high-quality pharmaceutical products tailored to specialty markets such as ophthalmic, veterinary, and homeopathic medicine. Our foundation in family values drives our commitment to operational efficiency, strict adherence to deadlines, and budget-conscious solutions for clients. With DEA and FDA-certified facilities, we offer end-to-end services from concept to commercialization, including technology transfers, scale-ups, and regulatory compliance. Our state-of-the-art laboratories support analytical testing, drug release validation, and microbiological services, ensuring product safety and efficacy. Over decades, we have guided more than 400 products to market, including NDAs, ANDAs, OTC medications, and nutritional supplements.Our culture emphasizes teamwork, innovation, and continuous improvement, enabling us to build lasting partnerships with clients. We prioritize confidentiality, timeliness, and cutting-edge R&D to address evolving industry challenges. Our facilities feature advanced stability testing chambers, sterile manufacturing capabilities, and high-potency compound handling systems. By integrating formulation development with GMP manufacturing, we deliver seamless transitions from clinical trials to commercial production. Our expertise spans solid dose, topical, and sterile ophthalmic manufacturing, supported by a dedicated team of scientists and technicians.
Services
Manufacturing Services
Analytical Services
Drug Release Testing
Microbiological Services
Stability Testing
Research & Development
Sterile Ophthalmic Manufacturing
High Potent Capability
Topical Manufacturing
Solid Dose Manufacturing
Highlights and features
- We have guided over 400 products into the market, including NDAs and ANDAs.
- Our DEA and FDA certified facilities ensure compliance and innovation.
- We guarantee confidentiality and timeliness in all client partnerships.
- We operate state-of-the-art facilities for comprehensive pharmaceutical testing and manufacturing.
- Our team specializes in process optimization to meet strict deadlines without compromising quality.
Associations and certifications
- DEA
- FDA
Services
Manufacturing Services
Sterling offers cGMP-compliant manufacturing for solid dose, topical, and sterile ophthalmic products. Our capabilities include blending, compression, encapsulation, and coating for tablets, capsules, and creams. We support batch sizes from 25 kg to 1,000 kg, serving OTC, Rx, and generic markets with 750 million tablets annual capacity.
Analytical Services
Our lab provides method development, validation, and product analysis using HPLC, GC, and IR instrumentation. Services include stability-indicating assays, extractable/leachable testing, and compliance with FDA and USP standards to ensure drug potency, purity, and safety during NDA/ANDA submissions.
Stability Testing
We conduct stability testing under controlled conditions (-80C to 40C/75% RH) to determine re-test periods and storage recommendations. Our ICH-compliant studies evaluate drug degradation over time, ensuring safety and efficacy throughout the product lifecycle.
Microbiological Services
Sterling performs microbial limit tests, sterility testing, and bioburden analysis per USP guidelines. Our services include cleanroom monitoring, antimicrobial effectiveness testing, and custom protocols to ensure pharmaceutical products meet microbial safety standards.
Drug Release Testing
We validate drug release profiles using dissolution testing and Karl Fischer water determination. This ensures consistent dosage form performance, compliance with regulatory requirements, and product safety for end-users through reproducible analytical methods.
Questions
What pharmaceutical services does Sterling offer?
Sterling provides manufacturing, analytical testing, drug release validation, microbiological services, stability testing, and R&D for ophthalmic, veterinary, and homeopathic markets.
Are Sterling's facilities certified by regulatory agencies?
Yes, our facilities are DEA-certified (C2-C5) and FDA-certified for compliance with pharmaceutical manufacturing standards.
What markets does Sterling Pharmaceutical serve?
We specialize in ophthalmic, veterinary, homeopathic, and over-the-counter (OTC) pharmaceutical products.
How does Sterling ensure product quality and safety?
We use advanced stability testing chambers, sterile manufacturing protocols, and microbiological testing compliant with USP/NF standards.
Can Sterling handle high-potency compound manufacturing?
Yes, our facility includes dedicated suites for high-containment processing of potent compounds with contamination prevention protocols.
