End to end support
Our business positioning is strengthened by our service offerings across markets, which enables us to act as an ideal partner for pharmaceutical companies. Our product and service lines together help us support our customers through all stages of the product lifecycle and be present across the value chain from product identification, R&D, impurity identification, methods development and controls, setting specifications and laboratory validation followed by technology transfer via pilot scale-up in the commercial plant. This is followed by plant validation enabling commercialization and large scale manufacturing. Our capabilities and experience have helped us perform well in regulated markets and have enabled us to successfully partner with customers.
Research and Development (R&D)
We have R&D capabilities across process research comprising portfolio evaluation; process development comprising feasibility studies, cost optimization studies, laboratory validation and development history report; process scale-up and validation; and regulatory filings and approvals. We also offer analytical research capabilities such as literature search; method development and optimization; characterization of impurities and standards; method validation; non-carry over studies and stability/hold-time studies.
INTELLECTUAL PROPERTY
We have a dedicated intellectual property team, which helps us file a number of patents in both the Indian and overseas markets in our research, process and platform technology areas. We expect to continue to file patent applications seeking to protect our innovations and novel processes in both developed markets and emerging markets.
QUALITY AND COMPLIANCE
Our products undergo multiple quality checks before reaching our customers. We have state-of-the-art quality control facilities with high end equipment to deliver high quality products to our customers. In addition to the periodic internal checks, our factories are audited regularly by customers and regulatory agencies.
We have been implementing cGMPs across each of our manufacturing facilities, which are monitored by a comprehensive QMS encompassing all areas of business processes from R&D and raw material procurement to manufacturing to packaging and delivery. We focus on product quality through compliance with global regulatory standards as well as compliance with local and state laws that encompass manufacturing regulations, environmental clearance norms and other statutory norms.
Since 2015, our facilities have been subject to 38 (41) inspections and audits by various regulators including the USFDA, PMDA, COFEPRIS, Health Canada, MFDS (Korea), EDQM, other European regulatory agencies and CDSCO conducted on a periodic basis.
CUSTOMER EXPERIENCE
Our people put customers at the centre of everything that they do. To understand, even preempt, customer needs is the hallmark of the Glenmark employee.
Our customers are our partners; we own their concerns. From tailoring product development according to the customers' requirement to timely delivery and end-to-end life cycle management, we work closely with our customers to deliver win-win outcomes.
REGULATORY
We understand that the global regulatory landscape of generics is a continuously evolving one.
We employ experts with a nuanced and current understanding of regulatory affairs in key geographies.
Customers are assured of our knowledge, experience and support to meet the requirements of the world's most demanding regulators successfully.
