Orbicular Pharmaceutical Technologies is adequately equipped to facilitate quality and efficient research work. The built facility in Hyderabad has pharmaceutical testing laboratory infrastructure incorporating state-of-the-art equipment providing capabilities in designing complex injectibles, topicals, opthalmics, parenterals & niche injectibles and sprays & inhalations.
Orbicular Pharmaceutical Technologies has well-established relationships with cGMP compliant contract manufacturing organizations (CMO) worldwide having excellent quality systems. This provides a great value proposition of turn-key product development and competitive supply of finished drug product.
Orbicular Pharmaceutical Technologies enjoys a preferred partner status with few selected GCP compliant and regulatory certified contracted services organizations and we would outsource the activities to these third parties fully being responsible for its quality and acceptability to regulations. This gives us a cost efficacy, flexibility and delivery leverage while providing Contract Manufacturing and Clinical Research services to our partners.
Our in-depth product design approach applying “ Quality-by-Design ” principles ensures that the design efforts translate into a more successful product scale-up. Our scientific teams spend extensive time researching on the in-vitro testing of the product replicating how a drug would works in the human body mimicking the In-Vivo conditions. The reward is a successful bio-equivalence establishment and equivalent efficacy as that of the brand.
Orbicular Pharmaceutical Technologies core competency is in the delivery of the following domain :
Our decades of hands-on experience in technology development, scale-up and implementation in various dosage form domains gives us a unique confidence of seamlessly transferring the technology to the manufacturing site of partners or third party cGMP sites.
Our teams are familiar with all the latest developments in the international regulatory environment. Our partnership network allows us to manage the execution, packaging of the regulatory submission batches in each of these dosage from domains.
We would like to be known not only for product development in the generic space, but also as a creator of innovative technologies and drug delivery systems. In the current global R&D scenario where the emphasis is on increasing need to maximize the value of existing active ingredients (NCEs) we would like to explore development of New Formulations, Line Extensions, Reduced Strength, Reduced Frequency, Combinations, and Alternate Routes of Administration for approved products or unapproved grandfathered products under consideration of 505 (b)(2) submissions.
In our quest for incremental innovation to add value or meet unmet medical need, we would continuously look for opportunities to change or improve the existing drug products and delivery systems. Our competency and strong knowledge base in the area of dosage design would be of great help to Speciality Companies looking for customized delivery systems.
Exploring alternate routes, product enhancement, modified release dosage forms design exploration product life cycle planning, line extensions and technology development are our Strategic Key Focus Areas.
Out-licensing of the niche generic products equivalent of brand products developed In-House ahead of time for specific geographies.
Out-licensing of the “generic plus” products with unique advantages for specific geographies.
Development of generic products through multiple Co Development formats and seeking business for the various offered services.
Rapid pipeline enhancement and augmenting their in-house capabilities to expand the product portfolio.
Product Design / Redesign, Formulation optimization, Line Extensions of Brands, Synergistic Combinations, PK parameters optimization
Out-licensing of the in-house developed technological innovations.
Any other Life Cycle Management Strategies.