Gland Pharma Ltd. IPO

We are one of the fastest growing generic injectables-focused companies by revenue in the United States from 2014 to 2019 (Source: IQVIA Report). We sell the products primarily under a business to business (“B2B”) model in over 60 countries as of June 30, 2020 including the United ... States, Europe, Canada, Australia, India and the Rest of the world. We have a consistent compliance track record with a range of regulatory regimes across these markets. We also have an extensive track record in complex injectables development, manufacturing and marketing and a close understanding of the related sophisticated scientific, technical and regulatory processes. We were established in Hyderabad, India in 1978 and have expanded from liquid parenterals to cover other elements of the injectables value chain, including contract development, own development, dossier preparation and filing, technology transfer and manufacturing across a range of delivery systems. We have a professional management team and one of the Promoters, Shanghai Fosun Pharma, is a global pharmaceutical major. We are focused on meeting diverse injectables needs with a stable supply of affordable and high quality products. We have established a portfolio of injectable products across various therapeutic areas and delivery systems. We are present in sterile injectables, oncology and ophthalmics, and focus on complex injectables, NCE-1s, First-to-File products and 505(b)(2) filings. the delivery systems include liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags and drops. We are expanding the development and manufacturing capabilities in complex injectables such as peptides, long-acting injectables, suspensions and hormonal products as well as new delivery systems such as pens and cartridges. Over the years, we have made substantial investments in the manufacturing infrastructure to support the product portfolio needs and reach. We have seven manufacturing facilities in India, comprising fthe finished formulations facilities with a total of 22 production lines and three API facilities. As of June 30, 2020, we had manufacturing capacity for finished formulations of approximately 755 million units per annum. the API facilities provide us with in-house manufacturing capabilities for critical APIs, enabling us to control costs and quality and mitigate supply chain related risks around the key products. the capabilities as a vertically integrated company include internal research and development (“R&D”) expertise, robust manufacturing capabilities, a strict quality assurance system, extensive regulatory experience and established marketing and distribution relationships. As of June 30, 2020, we along with the partners had 267 ANDA filings in the United States, of which 215 were approved and 52 were pending approval. The 267 ANDA filings comprise 191 ANDA filings for sterile injectables, 50 for oncology and 26 for ophthalmics related products. Out of these 267 ANDA filings, 101 represent ANDAs owned by us, of which 71 ANDA filings are approved and 30 are pending approval. As of the same date, we along with the partners had a total of 1,427 product registrations, comprising 371 product registrations in the United States, Europe, Canada and Australia, 54 in India and 1,002 in the Rest of the world. We have a consistent regulatory compliance track record and all the facilities are approved by the USFDA from whom we have had no warning letters since the inception of each facility. Other key regulatory agencies for which certain of the facilities have approvals include MHRA (UK), TGA (Australia), ANVISA (Brazil), AGES (Austria) and BGV Hamburg (Germany). Read more

Unless noted otherwise, the information in this section has been obtained or derived from the report titled “Global Injectable
Industry Overview” dated October 21, 2020, prepared by IQVIA (the “IQVIA Report”). All information contained in the IQVIA
Report has ... been obtained by IQVIA from sources believed by it to be accurate and reliable. IQVIA obtains information for its analysis from sources it considers reliable, but does not guarantee the accuracy or completeness of its analysis or any information contained in the IQVIA Report. Further, the IQVIA Report was prepared on the basis of information as of specific dates which may no longer be current or reflect current trends, and opinions in the IQVIA Report may be based on estimates, projections, forecasts and assumptions that may prove to be incorrect. IQVIA has confirmed that certain third-party information used or cited in the IQVIA Report has been obtained from publicly available information and acknowledgements of sources have been given wherever necessary in the IQVIA Report. IQVIA and its affiliates make no representation or warranty, either express or implied, with respect to the information or analysis from the IQVIA Report, including without limitation the implied warranties of fitness for a particular purpose and merchantability and IQVIA specifically disclaims any such warranty. The IQVIA Report is not a comprehensive evaluation of the industry, the Company or the Equity Shares and all material within the IQVIA Report should be deemed as expressions of opinion which are subject to change without notice. Read more