Dependency on the success of its relationships with its CDMO customers, including leading Indian pharmaceutical companies and multinational companies.
Any failure to comply with the quality standards and technical specifications prescribed by its CDMO customers.
Inability to identify and understand evolving industry trends, technological advancements, customer preferences, regulatory change, and innovate new products to meet customers’ demands.
Continuing impact of the outbreak of the COVID-19.
Highly competitive market.
Inability to meet any contractual obligations imposed by the CDMO agreements.
Insufficient cash flows from its operations or inability to borrow to meet its working capital requirements.
Non-compliance with the applicable environmental and workers’ health and safety laws and regulations.
Manufacturing operations are geographically concentrated in Dehradun, Uttarakhand.
Dependency on third-party qualified contract research organizations to conduct clinical trials and studies of the company’s new products.
Reforms in the healthcare industry and the uncertainty associated with pharmaceutical pricing, reimbursement, and related matters.
Inability to protect its intellectual property and proprietary information.
Any unscheduled, unplanned, or prolonged disruption of its manufacturing operations, such as strikes and lockouts.
Any shortfall in the supply of its raw materials or an increase in the raw material costs, or other input costs.
Risks associated with rejection of supplied products, and consequential claims, and associated product liability costs due to defects in its product.