Therapiva houses a state-of-art Research and Development center (LAXAI) spread over 50000 sq. ft. located in Genome Valley, Hyderabad. The R&D center is working on the development and optimization of new and existing process technologies for the manufacturing of New Chemical Entities(NCEs) and Active Pharmaceutical Ingredients (APIs). The R&D team includes highly experienced talent with global exposure, Ph.D./postdoctoral with multiple years of academic and Industrial experience, comprising Synthetic, Analytical scientists with dedicated IP and regulatory teams. Our R&D is well equipped with the skills to synthesize complex APIs of the highest quality kilo to tonnage scale with non-infringing processes adhering to regulatory norms in a cost-optimized, eco-friendly manner.

We provide:

  • Route Scouting
  • Process Development, Improvement and Optimization
  • Impurity Isolation, Identification, Synthesis and Structure Elucidation
  • Quality by Design (QbD) Process Evaluation
  • Technology Transfer, Process Scale-up and Validation
  • Salt and Polymorphism screening
  • API Physicochemical property evaluation
  • Genotoxic impurities evaluation and detection
  • Analytical Method Development and Validation
  • Stability studies as per ICH guidelines
  • Intellectual Property creation

About Laxai

LAXAI Life Sciences Pvt. Ltd. was established in the year 2007, with a vision to accelerate by providing innovative solutions across the spectrum of drug discovery and development programs of global pharmaceutical companies.

LAXAI acknowledges and strongly supports international efforts to advance drug discovery to meet the acute and chronic unmet medical needs. Our goal is to provide scientific solutions to our clients/collaborators/partners in strengthening their competitive advantage, with high quality, quick and reliable services.

We value the human capacity of creative imagination and believe that it should be nurtured. The dogma for business ethics at LAXAI is, that humanity should responsibly use modern technologies to improve the human condition of the present and future generations.

We are a 'Customer Centric' organization with a robust feedback mechanism enabling us to continuously improve the internal processes, communications, and program management.

Contract Development and Manufacturing Organization (CDMO)

We provide end-to-end services to bring a drug to the marketplace quickly and safely.

At LAXAI, we have created the infrastructure to provide Pharmaceutical Development and Manufacturing solutions for effective management of the drug’s life cycle. We provide services from Discovery to Development and Commercial Manufacturing of intermediates, NCEs and APIs. Our capability as an integrated service provider and experience with various emerging technologies enables us to serve the Innovator companies worldwide.

Concept to Commercialization

We help to increase the efficiency of production processes and reduce the risks associated with product development and/or commercialization. In this endeavor, our approach is to improve the stages which are limited for scalability in the initial discovery thereby making the entire drug life cycle process more cost-efficient with higher yields.

Meeting Your Small Molecule Needs

Small molecules represent 80 to 85% of the drugs on the market as well as those in late-phase development. We strive to adopt a broad, balanced and innovative portfolio of modern chemical technologies to suit the needs of our clients. Using various latest chemical processes - including continuous flow technologies and biocatalysis - we offer our customers exclusive synthesis of synthetically challenging high-value Key Starting Materials (KSMs), Regulatory Starting Materials (RSMs) and NCEs under cGMP for use in pharmaceutical products.

Backward-Integrated Industrial Manufacturing

LAXAI can manufacture quantity from kilo to tonnage scale. Our manufacturing strength stems from the comprehensive integrated network of resources for backward integration of starting materials/reagents, non-GMP intermediates at scale and securing the supply chain in terms of availability, quality, costs with risk mitigation and IP value addition.

cGMP and ISO-Certified Manufacturing Solutions

LAXAI provides alternative and innovative manufacturing solutions synergizing new technologies and classical chemistry. We are continuously investing in advanced chemical technologies and state-of-the-art facilities for development and building production capacity that ranges from gram to multi-kilograms.
LAXAI’s world-class manufacturing facility provides customers with complete manufacturing packages, created through close relationships, under strict confidentiality. The manufacturing facility complies with all regulatory guidelines and requirements cGMP and is successfully inspected/approved by the US FDA, EDQM, MHRA, and other global regulatory agencies. The facility is equipped with flexible and versatile infrastructure, tailored to fit complex chemistries and multiple products.

Our Differentiation

  • Improved product quality - every development project request is carefully analyzed and various alternative options are explored and provided for arriving at the best solution.
  • Create a robust, comprehensive control strategy using the principles of the Design of Experiments (DoE) and Quality by Design (QbD). This enables the chemistry developed to be readily scaled as the molecule advances from the early clinical phase to commercial production.
  • Speed to market by focusing resources on core competencies and optimizing the Return on investment.
  • Access to our advanced technologies and optimized processes to achieve CMC development milestones.
  • Benefit from LAXAI’s experience with worldwide regulatory authorities.
  • We have a team of professionals with international experience dedicated to delivering successful solutions to our collaborators.