<ul><li>As on March 31, 2024, we derive ?8,317.14 million and 97.40% of our revenue from operations from the United States and any adverse developments in the United States could have an adverse effect on our business and results of operations.</li><li>As the manufacture of our products is technically complex and highly regulated, product recalls, regulatory inspection failures or shortcomings at our manufacturing facilities or other problems may reduce sales, adversely affect our business, financial condition and results of operations and delay the launch of new products, and in some cases may lead to closures of our facilities.</li><li>We have a history of net losses, negative earnings per share ("EPS") and return on capital employed.
We need to generate and sustain increased revenues while managing our expenses to achieve profitability, and our inability to achieve these goals may have an adverse effect on our business,
results of operations, cash flows and financial condition.</li><li>In Fiscals 2024, 2023 and 2022, we derived 65.14%, 62.99% and 92.44%, respectively, of our revenue from sale of goods from our top five customers and the loss of one or more such customers could adversely affect our business and prospects.</li><li>We expect to spend a significant amount of resources on research and development efforts. Such efforts may not result in marketable products. Failure to successfully introduce products into the market could have a material adverse effect on our business, financial condition, and results of
operations.</li><li>Any disruption, breakdown or shutdown of our research and development and manufacturing
facilities may have a material adverse effect on our business, financial condition, results of operations and cash flows.</li><li>Our Company is involved in certain legal proceedings. Any adverse decision in such proceedings may render us/them liable to liabilities/penalties and may adversely affect our business, financial condition, results of operations and cash flows.</li><li>Our success depends on our ability to execute our growth strategies. If we are unable to sustain or
manage our growth, our business, results of operations, cash flows and financial condition may be adversely affected.</li><li>We face significant competitive pressures in our business from other pharmaceutical manufacturers.
Our inability to compete effectively would be detrimental to our business and prospects for future growth.</li><li>The market in which we operate is subject to consolidation and disruption, and our inability to
navigate such changes could adversely affect our business, financial condition and results of
operation.</li><li>Our operations are subject to high working capital and capital expenditure requirements, and our
inability to maintain an optimal level of working capital or financing required may impact our
operations adversely.</li><li>We are highly dependent on our Key Managerial Personnel and our Senior Management for our
business. The loss of or our inability to attract or retain such persons could have a material adverse effect on our business performance.</li><li>Our Corporate Promoter is a financial investor and does not have adequate experience in our line of
business, which may have an adverse impact on the management and operations of our Company.</li><li>We have had negative cash flows from operating activities in prior periods and may continue to have negative cash flows in the future.</li><li>If we are unable to patent new processes and protect our proprietary information or other intellectual property, our business may be adversely affected.</li><li>We are highly dependent on our skilled personnel for our day-to-day operations. The loss of, or our
inability to attract or retain such persons may have a material adverse effect on our business
performance.</li><li>If we are unable to protect our brand through intellectual property, or otherwise defend ourselves in challenges related to intellectual property rights, the sales of our products will suffer or be subject to substantial liabilities, which would have a material adverse effect on our results of operations.</li><li>We may unintentionally infringe upon the intellectual property rights of others, any misappropriation of which could harm our competitive position.</li><li>We are exposed to foreign currency fluctuation risks, particularly in relation to the translation of our financial statements and our borrowings, which may adversely affect our results of operations, financial condition and cash flows.</li><li>We are subject to foreign, federal, and state, anti-kickback, false claims, fraud and abuse laws, which may adversely affect our business.</li><li>We are subject to laws which aim to protect patients, such as payment transparency and data privacy laws, and the compliance with such laws may adversely affect our business.</li><li>Our financing agreements contain covenants that limit our flexibility in operating our business. If we are not in compliance with certain of these covenants and are unable to obtain waivers from the respective lenders, our lenders may accelerate the repayment schedules, and enforce their respective security interests, leading to a material adverse effect on our business and financial condition.</li><li>We have pursued inorganic growth opportunities in the past and acquired Validus. We may face
difficulties integrating acquired businesses and brands and we may be unable to realize the anticipated benefits of such inorganic growth opportunities, which may result in significant costs and impact our brand, business, results of operations and profitability.</li><li>We may utilize a portion of the Net Proceeds to undertake inorganic growth for which the target has not been identified. In the event that our Net Proceeds to be utilized towards inorganic growth
initiatives are insufficient for the cost of our proposed inorganic acquisition, we may have to seek alternative forms of funding.</li><li>We depend on third parties for the supply of our raw materials and manufacture of certain products
and such third parties could fail to meet their obligations, which may have a material adverse effect on our business, results of operations, financial condition and cash flows.</li><li>Healthcare reform and changes in pharmaceutical pricing, reimbursement and coverage, by governmental authorities and third-party payors may materially affect our business, financial position and operating results.</li><li>We regularly work with hazardous materials and activities in our operation which can be dangerous
and could cause injuries to people or property.</li><li>We have significant power and fuel requirements and any disruption to power sources could increase
our production costs and adversely affect our results of operations and cash flows.</li><li>Our insurance coverage may not be adequate to protect us against all potential losses, which may have a material adverse effect on our business, financial condition, cash flows and results of operations.</li><li>We have commissioned an industry report from Frost & Sullivan (India) Private Limited, which has
been used for industry related data in this Draft Red Herring Prospectus.</li><li>We are subject to various laws and extensive government regulations and if we fail to obtain, maintain or renew our statutory and regulatory licenses, permits and approvals required in the ordinary course of our business, including product safety, environmental, health and safety laws and other regulations, our business, financial condition, results of operations and cash flows may be adversely affected.</li><li>If we fail to introduce our generic products on a timely basis, our revenues, gross margin and results of operations may decline significantly. If we are not able to utilize the Section 505(b)(2) regulatory approval pathway, the approval pathway for product candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful.</li><li>Clinical drug development involves a lengthy and expensive process with uncertain timelines and
uncertain outcomes. If clinical studies of our product candidates are prolonged or delayed, or if we are required to conduct additional clinical studies for certain of our product candidates, we or any industry partners involved in the conduct of such studies may be unable to obtain required regulatory approvals, and therefore may be unable to commercialize our product candidates on a timely basis or at all.</li><li>We have relied and expect to continue to rely on third parties to conduct our clinical studies. If those third parties do not perform as contractually required, fail to satisfy legal or regulatory requirements, miss expected deadlines or terminate the relationship, our development programs could be delayed, more costly or unsuccessful, and we may never be able to seek or obtain regulatory approval for or commercialize our product candidates.</li><li>Our approved products may not achieve expected levels of market acceptance.</li><li>Our facilities are subject to client inspections and quality audits and any failure on our part to meet their expectations or to comply with the quality standards set out in our contractual arrangements, could result in the termination of our contracts and adversely affect our business, financial condition and results of operations.</li><li>Federal regulation of arrangements between manufacturers of branded and generic products could adversely affect our business.</li><li>Our products may have unanticipated adverse effects or possible adverse effects, and if we are sued by our customers or end users for defects in our products, it could harm our reputation and thus our profits and may subject us to regulatory investigations or sanctions.</li><li>The USFDA and other regulatory agencies actively enforce the laws and regulations prohibiting the
promotion of off-label uses.</li><li>We remain subject to ongoing regulatory obligations and continued regulatory review for approved product candidates, which may result in significant additional expense and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our product candidates.</li><li>Our failure to maintain optimum inventory levels could adversely affect our business, financial
condition, results of operation and cash flow.</li><li>Improper storage, processing and handling of our raw materials, work products and products could
damage our inventories and, as a result, have an adverse effect on our business, results of operations and cash flows.</li><li>Information relating to historical installed capacity and estimated capacity utilization of our
manufacturing facilities included in this Draft Red Herring Prospectus is based on various
assumptions and estimates and our future production and capacity utilization may vary. Underutilization of our manufacturing capacity and an inability to effectively utilize our manufacturing facilities may have an adverse effect on our business and future financial performance.</li><li>We will not receive any proceeds from the Offer for Sale portion and objects of the Fresh Issue for which the funds are being raised have not been appraised by any bank or financial institutions. Any variation in the utilization of our Net Proceeds as disclosed in this Draft Red Herring Prospectus would be subject to certain compliance requirements, including prior Shareholders' approval.</li><li>If we fail to maintain an effective system of internal controls, we may not be able to successfully manage, or accurately report, our financial risks. Despite our internal control systems, we may be exposed to operational risks, including fraud, petty theft and embezzlement, which may adversely affect our reputation, business, financial condition, results of operations and cash flows.</li><li>Failure or disruption of our information technology systems may adversely affect our business, financial condition, results of operations, cash flows and prospects.</li><li>Our suppliers and customers may engage in certain transactions in or with countries or persons that
are subject to international economic sanctions.</li><li>Our manufacturing facilities, research facilities and our Registered and Corporate Office are located on leasehold lands. If we are unable to renew existing leases or relocate our operations on commercially reasonable terms, there may be a material adverse effect on our business, financial
condition and operations.</li><li>We have certain contingent liabilities and commitments, which, if they materialize, may adversely affect our results of operations, financial condition and cash flows.</li><li>Any downgrade of our credit ratings could increase borrowing costs and constrain our access to
capital and lending markets and, as a result, could negatively affect our net interest margin and our business.</li><li>Our operations could be adversely affected by strikes or increased wage demands by our employees
or any other kind of disputes with our employees.</li><li>We rely on contract labor for carrying out certain of our operations and we may be held responsible
for paying the wages of such workers, if the independent contractors through whom such workers are hired default on their obligations, and such obligations could have an adverse effect on our results of operations, cash flows and financial condition.</li><li>Certain of our corporate records and filings are not traceable. We cannot assure you that regulatory proceedings or actions will not be initiated against us in the future, and we will not be subject to any penalty imposed by the competent regulatory authority in this regard.</li><li>Our Promoters and Promoter Group will continue to retain a majority shareholding in our Company
after the Offer, which will allow them to exercise significant influence over us.</li><li>Our ability to pay dividends in the future will depend on our future cash flows, working capital
requirements, capital expenditures and financial condition.</li><li>We have entered, and will continue to enter, into related party transactions which may involve conflicts of interest. Further, our Promoters, Directors and Key Managerial Personnel have interests in us other than reimbursement of expenses incurred and normal remuneration or benefits.</li><li>The determination of the Price Band is based on various factors and assumptions and the Offer Price of the Equity Shares may not be indicative of the market price of the Equity Shares upon listing on the Stock Exchanges. Further, the current market price of some securities listed pursuant to initial public offerings which were managed by the Book Running Lead Managers in the past, is below their respective issue prices.</li><li>The COVID-19 pandemic had a material and adverse impact on our business and operations, and its
resurgence or any future outbreak of other diseases may have an adverse effect on our business prospects and future financial performance.</li><li>We have presented certain supplemental information of our performance and liquidity which is not
prepared under or required under Ind AS.</li><li>Significant differences exist between Ind AS and other accounting principles, such as US GAAP and
International Financial Reporting Standards ("IFRS"), which investors may be more familiar with and consider material to their assessment of our financial condition.</li><li>A portion of the Net Proceeds may be utilized for repayment or pre-payment of a loan availed by our
Company from Axis Bank Limited, which is an affiliate of Axis Capital Limited, one of the BRLMs.</li><li>If we are classified as a passive foreign investment company for U.S. federal income tax purposes, U.S. investors in Equity Shares may be subject to adverse U.S. federal income tax consequences.</li><li>Certain of our Directors do not possess experience of being on the board of any listed company.</li></ul>