Strides gets USFDA Nod for Theophylline Extended-Release Tablets

Strides Pharma Science Limited on Friday, September 6, announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, from the United States Food & Drug Administration (USFDA).

Key Takeaways from USFDA’s Approval

• Strides Pharma's subsidiary has received USFDA approval for generic Theophylline Extended-Release Tablets, 300 mg and 450 mg.
• The tablets treat chronic asthma and lung conditions like emphysema and bronchitis.
• The product will be manufactured in Bangalore, targeting a combined market of around US$ 11.5 million.

The product is therapeutically and bioequivalent to Schering Corp.'s THEO-DUR® Reference Listed Drug (RLD). Theophylline extended-release tablets are advised for the treatment of reversible airflow obstruction and symptoms related to long-term lung conditions, such as emphysema and chronic bronchitis, as well as chronic asthma.

Theophylline Extended-Release Tablets, 300 mg and 450 mg have a total market size of approximately US$ 11.5 million, of which US$ 10.8 million is attributed to the 300 mg dosage, according to IQVIA.

The Theophylline Extended-Release Tablets, 300 mg and 450 mg will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India the company said in a stock exchange filing.

About Theophylline 

Theophylline Extended-Release Tablets (300 mg and 450 mg) are used to treat respiratory conditions such as chronic asthma, chronic obstructive pulmonary disease (COPD), and bronchospasm. This medication functions as a bronchodilator by relaxing the muscles surrounding the bronchial tubes, making breathing easier. It is especially effective in preventing and managing symptoms like wheezing, shortness of breath, and chest tightness. The extended-release formulation ensures a gradual release of the drug, minimising the need for frequent doses and providing steady relief from symptoms over an extended period.

About Strides Pharma Science Limited

Strides is a global pharmaceutical company based in Bengaluru, India, and is publicly traded on both the BSE Limited (532531) and the National Stock Exchange of India Limited (STAR). The company primarily operates in regulated markets and follows an "in Africa for Africa" strategy, along with an institutional business that caters to donor-funded markets. Strides has global manufacturing facilities in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York). 

About Strides Pharma Global Pte. Limited 

Strides Pharma Global Pte. Ltd. (SPG) serves as the international headquarters for Strides Pharma Science Limited, a global B2C pharmaceutical company primarily active in regulated markets like the US, Australia, Europe, and Canada. The company specialises in niche areas, with expertise in developing and manufacturing a variety of technically complex pharmaceutical products. Driven by a strong focus on quality and compliance, Strides Pharma provides a competitive edge in the fast-changing pharmaceutical industry.

The shares of Kalpataru Projects International Ltd. were trading in the green with an increase of 2%, hitting a high of ₹1,381.20 on the BSE after the company announced that it had secured orders worth ₹2,774 crore.

As of 12:57 pm, the shares of the company were up by ₹7.50, or 0.52%, trading at ₹1,362.80 on the NSE.

KPIL, one of the largest engineering and construction companies listed in India, along with its international subsidiaries, have secured new orders/notifications of awards of ₹2,774 crore, the company statement said in a statement on Thursday.

These orders include new projects in the Transmission & Distribution (T&D) business in overseas markets, as well as the Airports Authority of India's (AAI) EPC project for Airport Extension.

The new orders also include design and build projects for residential buildings in India.

Manish Mohnot, MD and CEO, KPIL, said in the statement, "We are pleased with the continuous ordering momentum, especially in our T&D and Buildings and Factories (B&F) business."

The order from the AAI will mark our entry into the growing domestic airport sector and further diversify our clientele, he added.

The orders in the T&D and B&F businesses have further enhanced our market position and significantly strengthened our order book, he said.

With the orders wins, our YTD (year to date) order intake has reached around ₹9,800 crores, and additionally, we have greater business visibility, he stated.

KPIL is one of the largest specialised EPC (engineering, procurement, and construction) companies engaged in power transmission & distribution, B&F, water supply & irrigation, railways, oil & gas pipelines, urban mobility (flyovers & metro rail), highways and airports.

KPIL is currently executing projects in over 30 countries and has a global footprint in over 70 countries.

Tata Steel announced on Wednesday that the company has signed a £500 million grant funding agreement with the United Kingdom (UK) Government. The agreement pertains to a £1.25 billion green steel project in Port Talbot. Following the announcement shares of Tata Steel were trading by 0.78% at ₹149.32 per share.

The company stated that the agreement will allow it to proceed at pace with the project to install an electric arc furnace at Port Talbot for steelworks in Wales. Tata Steel stated that the project will bolster the UK’s steel production along with preserving 5,000 jobs. The £1.25 billion project marks the largest investment in the UK steel industry in decades.

The new assets will aid in reducing the UK’s total industrial carbon emissions by 8% with Port Talbot seeing a 90% reduction in emissions. The reduction in emissions will be achieved by utilizing scrap.

In addition to £750 million investment by Tata Steel, the company will also leverage its engineering and project capabilities for the project. The company reported that the basic engineering is complete and equipment orders will be placed shortly for the electric arc furnace (EAF) and ladle metallurgy furnaces, a new coil box, and crop shear for the hot strip mill. Further, a cranes package for construction management and civil engineering will also be procured.

The project will also provide employees that are leaving with support packages along with a re-training scheme for employees that are at-risk of compulsory redundancy.

T V Narendra, chief executive officer and managing director of Tata Steel, said that the government’s support will help the company transform Port Talbot. The company will continue working with the Transition Board and the UK and Welsh governments to boost the economy and job creation in South Wales.

“With the UK government’s critical support, this complex and ambitious transformation of Port Talbot has the potential to make the plant one of Europe’s premier centres for green steelmaking,” he said.

Shares of the company have risen by nearly 7% since the beginning of the year. The stock has gained over 15% in the past year.

Shares of Premier Energies extended their bullish streak for the third consecutive trading session, rising another 18.3 percent in early morning trade today to reach ₹1,188.90 per share.

The stock debuted on Indian exchanges on September 3 with a massive 120 percent premium over its issue price of ₹450 per share. Since then, it has maintained a strong upward trend, now trading 164 percent higher than its IPO price.

On Thursday, the company announced that it had secured an order from the Uttar Pradesh Department of Agriculture to supply, install, and commission 8,085 solar water pumping systems across various districts. The project, valued at ₹215 crore, includes a five-year comprehensive warranty and is expected to be completed by March 2025.

This initiative falls under Component-B of the PM-KUSUM (Pradhan Mantri Kisan Urja Suraksha evam Utthaan Mahabhiyan) scheme, which aims to ensure energy security for farmers in India, along with honouring India’s commitment to increase the share of installed capacity of electric power from non-fossil-fuel sources to 40 percent by 2030 as part of Intended Nationally Determined Contributions (INDCs).