The company has established a R&D center for pharmaceutical preparations, which has installed with a variety of advanced international brand equipment and instruments, and a management system. The R&D staff has many years of working experience and technological expertise, with a focus on research and manufacturing of generic drugs and innovative formulation drugs that has good commercial potential or technological barriers. The staff is also highly experienced in problem-solving, and can provide unique solutions to the problems encountered in development of water-insoluble drug products, sustained and controlled release drug products, compound drug products and topical drug products.
Solubilization Platform for Insoluble compounds
Solubilization Platform for Insoluble Drug is of high technological barrier in nature, it is composed of special formulation and process control that are mainly designed to improve the solubility of poorly soluble drugs and increase their oral bioavailability. The company, which has rich technical expertise in this area and product developed experience, focuses on the unique characteristics of a given insoluble compound, aims to produce solid dispersion out of the compounds through technologies such as spray drying, hot melt extrusion, self-emulsification, nano solubilization, intestinal positioning solubilization technology, and match them with manufacturing systems to attain solubilized products.
R&D Platform for Sustained and Controlled Release Formulation
The platforms for Sustained and Controlled Release products is composed of surface area controlled sustained-release technology, matrix sustained-release technology, bilayer sustained-release technology, complex beads/tablet coating technology, sustained-release capsule technology and other sustained-release technologies. Relying on these platforms, the company has mastered and demonstrated capability in the formulation development and production of matrix tablets, gastric retention tablets, osmotic pump tablets, sustained-release micro tablets/pellets, pulse release formulations, and enteric coated tablets, all of which are often considered to have high commercial potential or technological barriers.
Platform for Fixed-dose Combo Formulation development
The platform for Fixed-dose Combo is a set of evaluation methods and development processes composed of clinical evaluation, special compatibility and formulation consideration, and process design/control. Multi-component bilayer tablets, multi-layer tablets, coated tablets, multi-particle capsules, micro-tablets capsules and other dosage forms with different ratio of drug combinations can be attained and developed to meet beneficial clinical requirements.
R&D Platform for Topical Formulation
Topical Formulation is more convenient to use, and can be administered locally to relieve symptoms and achieve local treatment or percutaneous absorption for systemic treatment. The company has technical expertise for various kinds of topical product developments, include gels, ointments, creams, liquid preparations, liquid-filled depot patches, semi-solid-filled matrix patches, and drug loaded pressure-sensitive adhesive matrix patches.
Comply with Chinese GMP, US GMP standards
Comply with US GMP and EU GMP standards
Received a certification of GMP issued by NMPA
Received and passed multiple on-site audits by FDA
GMP Analysis Lab
Received and passed multiple on-site audits by FDA and NMPA (cFDA)
Haimen Pharma, the company wholly owned manufacture facility, is located in Haimen City Jiangsu Province, about 2 driving hours away from the headquarter. The manufacture site, has a total area of about 55,000 square meters which includes 8200 square meters GMP formulation production workshop and a high-potency formulation manufacture suite. It is well equipped and is setup for production of scale-up batches, exhibit batches, validation batches and commercial batches.
Haimen Pharm received a certification of GMP issued by NMPA in 2015 and passed on-site inspections by US FDA in Sep 2016.