We believe in
overcoming problems
by going into the
first principles
of science.
We believe in overcoming problems by going into the first principles of science.
Rubicon Research has 2 state-of-the-art R&D centers in India and Canada.
1. Rubicon Research Corporate HQ and R&D Center in Thane, India
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:
- Oral Solids
- Tablets: Immediate release, sustained release, delayed-release, controlled release, film coated, enteric-coated tablets
- Capsules: Powders, granules, pellets
- Powders: Sachets, direct-to-mouth, powder for suspension (for immediate release, delayed release or extended release)
- Oral Liquids
- Syrups, solutions, suspensions (for immediate release and modified release)
- Release multi-ingredient suspension
- Penn-kinetic technology know-how, ion exchange complexation
- Topical
- Creams, ointments, gels, lotions, foams
b. Sterile facility to support development of:
- Ophthalmic: Solution, suspensions
- Injections: Liquid and lyophilized injections, drug-device combination products, complex injectables, including suspensions and depot formulations
c. Development facility for handling High Potency Compounds
- The high potency suite is a facility for solid and liquid products, including oncology and hormonal products (OEL category 4 and 5 compounds). A dedicated and self-contained formulation laboratory incorporates pressure gradients facilitating containment of particles, single pass air system in the area, reverse laminar airflow and personal protective equipment (PPEs) for protection of personnel, decontamination area for material and garments.
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.
2. Rubicon Research Canada HQ and R&D Center, Concord, Canada
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:
- Nasal and pulmonary inhalation products
- Pressurized metered dose inhalers (pMDIs)
- Dry powder inhalers (DPIs)
- Metered nasal sprays
- Small volume nasal sprays (eg: single dose)
- Topical sprays
- Ophthalmics
The R&D center has developed:
- 7 Rx FDA-approved products, including four generic CFC pMDI products for the US market
- Products for United Nations development program to help transfer the pMDI products from CFC propellant to HFA for developing nations
- Generic nebule and ophthalmic products
The center has been audited and approved by international regulatory authorities, including the US FDA and Health Canada.