30 North Jefferson Road
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Halo Pharmaceutical is a contract development and manufacturing organization that provides scientific, regulatory and development expertise as well as a wide spectrum of manufacturing services to help customers bring their products to market quickly, effectively and on budget. Halo offers fully integrated capabilities in a variety of dosage forms including tablets, minitablets, capsules, powders, oral liquids, creams, sterile and nonsterile ointments and suppositories. Halo Pharmaceutical’s capabilities in the areas of tech transfer, process and product development, production, scale-up and validation and analytical method development allows us to partner with clients from development through commercialization or at any point along the way. Halo’s specialty is in the manufacture of controlled substances (DEA CI-V) for both the US and Canadian markets with additional expertise in abuse deterrent technologies and dosage forms.
Services & Capabilities:
Halo’s products and services are organized into a variety of areas including Pharmaceutical Development, Commercial Manufacturing, Formulation and Pre-formulation services. Specializing in all aspects of the CMC section of ANDA or NDA’s. Halo Pharmaceutical’s development services extend from Phase I through registration and include Project Management, Formulation Development and Analytical Development.
Halo’s Commercial Manufacturing capabilities include Controlled Substances (DEA Schedule I – V), Sustained & Extended Release Formulations, Bi-layer Tablets, Bead & Pellet Coating, Extrusion/Spheronization, Solvent based formulations, Mini Tablets – Stick Packs and Capsules, Liquids, Non sterile Creams & Ointments, Sterile Ointments and Suppositories. Halo produces over 500 SKU’s of FDA and Health Canada approved commercial products and works with customers ranging from start-ups to large pharma companies including working with 9 of the top 10 large pharma and all of the top 10 generic companies.
Halo has two locations, one in Whippany, NJ (175,000 sq. ft.) and one in Montreal, Quebec (226,000 sq. ft.). The Whippany facility is capable of developing, manufacturing and finishing oral dosages, liquids, suppositories and sterile ointments including the ability to do all dosage forms for DEA Schedule I-V. The facility in Montreal, Quebec specializes in development through commercialization of liquids, ointments, creams, suppositories and oral solid dosage forms. Both facilities have excellent regulatory histories, with the Whippany facility approved to commercially supply products by FDA/MHRA and the Montreal facility approved to supply commercial products by Health Canada/FDA.