Expertise in a wide range of dosage forms

Develops drug product formulations for the targeted delivery of therapeutics and establishes GMP manufacturing processes to ensure high-quality clinical trial material.

We develop finished products supporting IND, NDA filings and generic ANDA filings. Our facilities have been designed for flexibility, as we offer a variety of dosage forms and the ability to handle highly potent compounds and DEA-controlled substances.

Fact: We have worked with 400+ clients, supporting 400+ compounds and 700+ GMP batches.

[Webinar] Sterile Nanoemulsion Product Development: Challenges and Future Prospects

Case Study – A nano emulsion development. Learn about a nanoemulsion development process using a microfluidizer, and find out what factors to consider while developing a sterile ophthalmic nanoemulsion formulation.

• IND/NDA: R&D-Formulation development, CTM manufacturing for Phase-I to III and subsequent NDA submission batches of oral solids, semisolids (topical), liquid, and sterile dosage forms
• ANDA: Reverse engineering, formulation development, Scale up and submission batches
• High potency suite for CTM manufacturing, Registration and Commercial batches
• Sterile suite for CTM manufacturing (Phase I to III and Commercials)
• DEA manufacturing license for controlled substances (I-V)
• Proof of Concept non GLP and GLP supplies
• Integrated services with Frontage’s Safety Toxicology labs and clinical center for GLP Tox studies and First in Human Studies to Phase-I studies       

Read our article on the development of nanoemulsions and their use as drug-delivery systems.