Oral Dosage, Sterile Ointments and APIs
Halo Pharmaceutical is a privately owned full service FDA, BLA and DEA (Schedule II-V) compliant CDMO, headquartered in Whippany, New Jersey, US. The facility has been producing a variety of oral dosage, sterile ointments and APIs for over 35 years.
Contract manufacture of brand pharmaceuticals
Halo currently provides contract manufacturing services, including:
- Brand products to large brand pharmaceuticals
- Brand products to mid-size brand pharmaceutical companies
- Products to mid-size specialty pharmaceuticals
In addition to manufacturing, Halo Pharmaceutical offers a wide range of development services with expertise in the areas of product and process development, analytical methods development, production scale-up and validation, technology transfer and dedicated laboratories and pilot facilities.
Pharmaceutical development, manufacture, production and packaging
With the pharmaceutical development capabilities available at the site scale-up from development to full commercial-scale equipment is easily supported. Our analytical laboratories have the necessary capabilities to support products throughout the development, scale-up, validation and commercialization phases.
For existing commercial products where the product sponsor is contemplating a change in their material sourcing the technical personnel at the site have the expertise and experience to support all aspects of the technology transfer process from the existing commercial-scale process.
Solid and liquid oral dosage form manufacture
With over 30 years of experience in pharmaceutical manufacturing, Halo’s staff at the Whippany facility has the experience and a wide range of granulating, blending, compressing and coating equipment necessary to support the needs of our customers.
Sterile ointment manufacture
The Whippany site has been successfully and reliably manufacturing sterile ointment for the past 30 years. The aseptic process suite includes through the wall 0.2µm sterile filtration of a petrolatum base into a sterile mixing tank. Organic insoluble sterile active pharmaceutical ingredient is aseptically added to the sterile filtered base via a closed system barrier isolator and transfer port fitted to the top of the tank and maintained to Grade A standards.
After mixing, the sterile ointment is then pressure-transferred to a sterile tube filler located in a Grade A zone. All sterile product contact equipment, including the sterilizing filter mixing tank, transfer tubing and filler, is sterilized via a validated steam in place cycle. Aseptic transfer of pre-sterilized containers and closures to the sterile filling zone is accomplished through the consecutive aseptic removal of sterile protective wraps, the last wrap being removed in the Grade A zone.
Packaging of solid, liquid and semi-solid non-sterile and sterile dosage forms
Halo’s Whippany site has the ability to package solid, liquid, suppository and semi-solid non-sterile and sterile dosage forms into a variety of bulk or final packages, or in a form as requested by our customers. Different lines are equipped with bar code readers and vision systems with optical character recognition capabilities. Checkweighers are utilized to further ensure compliance.
Primary packaging is conducted in enclosed rooms isolated by positive air pressure differential from secondary packaging operations.
Research and development, validation and regulatory submission preparation
Halo offers a wide range of development and manufacturing services with expertise in the areas of tech transfer, process, product and methods development, production scale-up and validation.
Halo’s development capabilities can assist in bringing products to market quickly. Specializing in all aspects of the CMC dosage form section of the NDA, Halo’s dedicated laboratories and pilot facilities can assist at all stages of development, from pre-clinical to Phase III. After registration, products can progress naturally into the Whippany commercial facilities where the same development scientists and manufacturing specialists can scale the production activities for commercial supply.