Strides Gets Approval For Ibuprofen Oral Suspension From USFDA

Strides Pharma Science said that its step-down wholly owned subsidiary company Strides Pharma Global, Singapore has received nod for Ibuprofen oral suspension USP, 100 mg/5 mL from the United States Food & Drug Administration (USFDA).

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin oral suspension, 100 mg/5 mL of McNeil Consumer Healthcare (McNeil).

The product will be manufactured in company’s facility at Bengaluru and will be marketed by Strides Pharma Inc. in the US market.

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) derived from propionic acid. It is non-selective cyclooxygenase (COX) inhibitor used to treat mild-moderate pain, fever, and inflammation. It is also used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches and arthritis among others.

According to IQVIA MAT March 2022 data, the US market for Ibuprofen oral suspension USP, 100 mg/5 mL is approximately about USD 66 million (around Rs. 511 core).

Strides has 274 cumulative Abbreviated New Drug Application (ANDA) filings with USFDA of which 250 ANDAs have been approved and 24 are pending for approval.

The company has about 60 commercialised products in the US market currently and has set a target to launch about 20 new products every year from the combined portfolio.

Bengaluru-based Strides is a global pharmaceutical company. The company mainly operates in the regulated markets and has an ‘in Africa for Africa’ strategy along with an institutional business to service donor-funded markets.

The company’s global manufacturing sites are located in India (Chennai, Puducherry and two locations in Bengaluru) , Singapore, Italy, Kenya and the United States (US).

The drug maker reported a 36.6 per cent decline in consolidated net profit to INR 29.22 crore on a 4.7 per cent fall in net revenue from operations to INR 866.02 crore in Q4 FY22 over Q4 FY21.

According to the Industry Research, the country is the second largest supplier of Ibuprofen, enjoying production market share nearly 30 per cent.

The global Ibuprofen market was valued at USD 89 million in 2020 and is expected to reach USD 109 million by the end of 2027, growing at a CAGR of 2.7 per cent during 2021-2027.

Indian Health Care Market

According to India Brand Equity Foundation (IBEF), By FY22, Indian healthcare infrastructure is expected to reach USD 349.1 billion (2,706 lakh crore).

In 2021, the Indian healthcare sector was one of India’s largest employers as it employs a total of 4.7 million people. The sector has generated 2.7 million additional jobs in India between 2017-22 -- over 500,000 new jobs per year.

In the Economic Survey of 2022, India’s public expenditure on healthcare stood at 2.1 per cent of GDP in 2021-22 against 1.8 per cent in 2020-21 and 1.3 per cent in 2019-20.

Government Initiative

In order to boost the healthcare industry, the central government has come up with various initiatives. In the union budget 2022-23, the government allocated INR 86,200.65 crore to the Ministry of Health and Family Welfare (MoHFW), INR 10,000 crore was allocated to Pradhan Mantri Swasthya Suraksha Yojana (PMSSY).

Under the budget, human resources for health and medical education was allotted INR 7,500 crore while National Health Mission was allotted INR 37,000 crore.

As of April 2022, a total of 1,17,771 Ayushman Bharat-Health and Wellness Centres (AB-HWCs) are operational in India and 748 e-Hospitals were established across country as part of the central government’s ‘Digital India’ initiative.

In November 2021, the government of India, the government of Meghalaya and the World Bank signed a USD 40-million health project for the state of Meghalaya. This project will improve the quality of health services and strengthen the state’s capacity to handle future health emergencies, including the COVID-19 pandemic.