When the Securities and Exchange Board of India (SEBI) gave its nod to the injectables-firm Gland Pharma to launch an initial public offer (IPO) in late October, the news came as nothing less than a silver lining on the horizon of an industry which is overcast by the protracted pandemic clouds.

The tidings infused a fresh bout of vigor not only to the contract development and manufacturing organizations (CDMOs) dealing with sterile injectables but to the entire pharmaceutical industry, as well. The pharma sector was receiving such news from India’s regulator of the securities and commodity markets after a gap of over three years.

Reports said the company and its shareholders were planning to raise as much as 64.5 billion rupees ($871 million) from the capital market by selling as many as 43.2 million shares in the offering. The IPO so far was the biggest by a pharmaceutical firm in India. The $260 million share sales by Eris Lifesciences in 2017 set the record in this sector. Gland’s was also the country’s second-biggest IPO in the year 2020 after a $1.44 billion offering by SBI Cards.

Gland Pharma is backed by Shanghai Fosun Pharmaceutical (Group) Co. The Chinese company acquired a 74% stake in the Hyderabad-based firm for about $1.1 billion in 2017.

Gland Pharma is a pure-play sterile injectables manufacturer with a portfolio of products across various therapeutic segments such as anti-diabetic, anti-infectives, anti-malarials, anti-neoplastics, ophthalmics, cardiac, gastrointestinal and hormones through a combination of delivery systems including liquid vials, lyophilized vials, pre-filled syringes, ampoules, bags and drops.

According to the company website, Gland Pharma is enabled to meet diverse injectable product needs across a vast range of specific requirements with 22 production lines for finished formulations across four facilities. Three of its factories are dedicated to API production. This backward integration eliminates the uncertainty of APIs and allows the company to achieve greater control over manufacturing, operating efficiencies, product development, quality control and supply chain. The company is planning to augment its manufacturing capacity of approximately 750 million units in the medium term.

The formulation manufacturing facilities, which use aseptic filling or terminal sterilization, are equipped for production flexibility and can switch product lines seamlessly, obviating the need to install additional production lines to meet altered product specifications and market demand.

With expertise in the synthesis of complex drug molecules such as low-molecular-weight heparin (LMWH), corticosteroids, peptides and cytotoxic molecules, the company has secured several product approvals from various regulators including U.S. FDA and UK MHRA.

The bulk of Gland’s revenues come from the U.S. and EU markets even though the company currently exports injectables and other sterile products to over 60 countries. In 2019-20, about two-thirds of its earnings were posted from the U.S. market. Gland Pharma is one of the fastest-growing companies in the segment by revenue in the U.S. from 2014 to 2019, as per the company’s filing.

Gland Pharma said the proceeds from IPO would be used for Capex and working capital for its Indian operations. The company plans to expand its manufacturing capacity and add more products to its pipeline.

Experts see targeted investments happening in the future in sterile injectable contract manufacturing organizations (CMOs) as the demand for the generic injectable products grows.

The global generic sterile injectables market is estimated to reach $196.2 billion by 2029 with a CAGR of 11.2% during the forecast period, says a report by Prophecy Market Insights.

Casting an eye on the faster clip growth, companies are expanding their product offerings and manufacturing capacities.

Biological E, a biopharmaceuticals firm, announced the acquisition of Akorn India Ltd., a subsidiary of U.S.-based Akorn Inc. to boost the Hyderabad-based company’s manufacturing capacity in August. Akorn India’s facility at Paonta Sahib in Himachal Pradesh has a sterile injectables plant with an annual capacity to manufacture nearly 135 million units and has the potential to immediately expand by a further 30 million units. 

The buyout is expected to give a fillip to Biological E as the company has a manufacturing agreement with Janssen Pharmaceutica NV of Johnson & Johnson for its COVID-19 vaccine candidate which is currently in phase 1 and 2 clinical trials. 

Late last year, Strides Pharma Science said that the company was making an additional investment in Stelis Biopharma Private Ltd., an injectables CMO-based in Bangalore. Strides, which sold its injectables business to Mylan in a $1.6 billion deal in 2013, is planning a re-entry into the steriles manufacturing space, the company said.