As the pharmaceutical industry continues to undergo rapid technological advancements, we are upgrading our R&D facilities to achieve better outcomes. Moreover, to retain our position as a key player in the industry and to meet evolving customer needs, we are consistently adopting advanced technologies and improving our manufacturing processes.
As on March 31, 2021, Gland along with its Partners have total
Our tenacity to consistently receive regulatory approvals, commercialise our pipeline and achieve market penetration is reflected in our revenue growth from new product launches.
Our R&D expertise, enables us to continuously upgrade and enhance our product development capacities. Our laboratories are equipped with state-of-the-art equipment including synthesizers, microwave assisted reactors, liquid chromatography-mass spectrometry and nuclear magnetic resonance spectroscopy that add efficiency to manufacturing processes.
R&D expense as a percentage of revenue
R&D Expense (₹ million)
Our R&D team includes PhDs, pharmacy postgraduates and chemists. The team is involved in the synthesis of low molecular weight heparins, steroids, oncology drugs and the development of complex injectables, such as lyophilized products, high-potent drugs and long-acting suspensions, lend a competitive advantage to our Company. Our R&D laboratories are involved in the development of formulations, analytical methods, API processes and stability studies.
We have advanced capabilities that enable us to focus on the development of technically-challenging products, including generic injectables, characterising complex molecules, analysing and synthesising peptides and proteins. These technological capabilities have enabled us to produce bioequivalent versions of complex drugs. Our proficiency also supports development and manufacturing of a broad range of dosage formulations, including solutions, suspensions and lyophilized products as well as products administered through pre-filled syringes, vials, ampoules, bags and dry powder injections. Our injectable product technologies have also enabled us to develop and manufacture generic injectables in liquid, lyophilized, suspension forms, as well as for pre-filled syringes.
Characterisation of complex molecules is important for the development of a generic product that is the same as a reference drug. Complex molecule drugs have very slight variances, making it difficult to characterise them. We have developed analytical tools that have enabled us to characterise complex molecules in our products and product candidates. This allows us to demonstrate ‘sameness’ to the USFDA.
Some of our success stories include synthesis and characterisation of glycosaminoglycans, including heparin, low molecular weight heparins, chondroitin sulphate, hyaluronic acid and drug conjugates of glycosaminoglycans. We also possess the technology to develop complex steroids such as vecuronium, rocuronium, fulvestrant and vitamin D analogues.
Our technology also enables us to characterise other complex molecules, including protein-based products. The development of peptide and protein drug products utilise characterisation technology as well as sterile API manufacturing technology. The sterile API technology has enabled us to successfully develop betamethasone acetate, paliperidone palmitate, loteprednol etabonate, aripiprazole hydrate and aripiprazole lauroxil. We have also developed non-infringing polymorphic forms of APIs, such as Tigecycline and Bortezomib, and novel processes for oncology APIs, such as cabazitaxel and pralatrexate.
Being in the B2B business, we also handle technology transfer projects, wherein the customer transfers the technology to us. We have a separate manufacturing science and technology team with project leaders experienced in injectables manufacturing and project management, to specifically concentrate on our technology transfer capabilities.
Technology transfer involves technical gap analysis with respect to manufacturing and analytical methods, analytical method transfers, verification of APIs and finished products, project specific validations, execution of trial and submission batches, stability studies, preparation of documents for dossier submission and project management.
Our technology transfer team possesses a keen understanding of the technology involved in site transfer projects, with respect to manufacturing and analytical methods as well as sourcing project specific components required to ensure the efficient execution of projects. As a result of our expertise, we have a strong track record of multiple CBE-30 filings and approvals.
Our R&D expertise directly supports our required regulatory filings worldwide. Our product capabilities are also further reinforced by our drug regulatory capabilities that facilitate registration of complex injectables across product lifecycle and markets.
Our regulatory team has extensive experience about the regulatory requirements of our core markets and, therefore, simplify new product registrations. The regulatory team is constantly engaged with regulators, including the USFDA, and plays an active role in achieving operational efficiencies by undertaking CBE-30 filings for site and line changes as well as filing for change of APIs, when cost-effective sources are available.
We own several patents covering processes and equipment used in the manufacturing of our products. As on March 31, 2021, Gland Pharma has 12 registered patents. It has applied for the registration of 13 patents in India.