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Manufacturing Services

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Sterile Ophthalmic Manufacturing

Our manufacturing facility is built for the purpose of manufacturing sterile ophthalmic products including solutions, suspensions, ointments, gels, and trusted aseptic capabilities. We package in metal and laminate tubes, three-piece bottles (3-20 ml), multi-dost preservative free bottles, and unit of use strips.

High Potent Capability

Our facility can also handle High Containment of potent compounds through a closed manufacturing system. We currently have multiple dedicated processing suites and supporting infrastructure, along with a dedicated packaging room along with a remote documentation room. When a chemical is introduced to our facility, we ensure that multiple studies are performed to ensure that there is no contamination.

refrigerator with glass doors storing individual bottles of solutions

Topical Manufacturing

Sterling manufactures batches for toxicology testing and clinical trials and can create registration batches for generic submissions. The Sterling team have significant experience in compounding, filling, packaging and labelling of all formulation types, ensuring they are ready for use in both clinical and commercial use. Sterling supports clients with a seamless transition from Formulation Development through to Product Manufacturing, ensuring an end-to-end service that compliments the client’s clinical research activity.

Our GMP accredited facilities are capable of GMP manufacturing for all topical formulation types including liquid and semi-solid manufacturing in batch sizes up to 1000 kg.

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Solid Dose Manufacturing

At Sterling we provide solid dose manufacturing to leading organizations within the United States. We produce solid dose tablets for small to medium batch sizes and are committed to quality, customers service, and innovative and cost-effective solutions.

Our pharmaceutical manufacturing capabilities include blending, fluid bed drying, high and low shear granulation, compression, encapsulation and tablet coating. We provide manufacturing for both over-the-counter (OTC) and prescription (Rx) products, offering our clients specialized, reliable, and cost-effective services.

With an annual capacity of over 750 million tablets, we can manage batch sizes 25 kg to 300 kg and tablet sizes ranging from 100 mg to 2 g.

Woman with white gown and hairnet loading a packaging machine.

Technology Transfer

At Sterling Pharmaceutical, we are experienced in supporting clients who have an existing ANDA or NDA that we can transfer in to our facility and perform all the regulatory files for approval on our site.

Our DEA (C2-C5) and FDA certified facilities have the capacity to handle new drug entities, technology transfers, and scale-ups in one-centralized location from concept to commercialization. Our continuous commitment to confidentiality and timeliness has allowed us to build not only a commercial partnership, but a relationship with our clients.

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