Rubicon Research has 2 state-of-the-art R&D centers in India and Canada.
Commissioned in 2018, the 38,000 square feet modern facility focusses on formulation development and drug product analytical development. There are three formulation facilities.
a. General category facility to support development of:
b. Sterile facility to support development of:
c. Development facility for handling High Potency Compounds
The R&D team is supported by the technical services team and method validation team based at the manufacturing site in Ambernath as well as at partner contract manufacturing organizations. The product/ technology developed at R&D is scaled up and validated at the Ambernath site or at partner contract manufacturing organizations to ensure integrated and seamless executed of products for filing and commercialization.
The in-house analytical method development laboratory has stability chambers and all laboratories are built to cGMP standards with requisite building and environmental controls. There is a capability to expand the laboratories to include analytical method validations, and bespoke stability/ sample storage areas.
The R&D team comprises of about 150 scientists and technical staff engaged in all aspects of pharmaceutical research, i.e. formulation development, analytical development, packaging development, clinical and bioequivalence studies, intellectual property management and regulatory affairs. The R&D Center develops products, proof of concepts and novel technologies spread across various therapeutic areas and dosage forms.
The 15,000 square feet development and testing facility offers comprehensive drug product formulation and process development, as well as wide-ranging analytical testing services, specializing in nasal and pulmonary drug delivery systems and ophthalmic, otic, and dermal products. The center comprises of a laboratory, small pilot manufacturing, document storage, and sample storage, and has equipped itself with highly specialized equipment and formulation and analytical chemists with a proven track record in developing pulmonary and nasal drug products.
Facility supports the development of:
The R&D center has developed:
The center has been audited and approved by international regulatory authorities, including the US FDA and Health Canada.