Cipla Gets US FDA Approval for Albuterol; What Does This Mean for India?

Cipla Gets Approval from USFDA for Albuterol Sulfate

Well-known pharmaceutical company Cipla Ltd added another feather in its cap as the US Food and Drug Administration (USFDA) has approved the company’s albuterol sulfate, medicine is used in the treatment of breathing difficulties. Currently, the US has been struggling with a significant number of infected patients of deadly COVID-19 cases. India has been widely referred to as a power-house of pharmaceutical companies. With this move, Cipla will be able to access the US market and with it, reach a global market too. This achievement has set a precedent for all pharmaceutical companies in India to grow its ambitions.

What is Cipla known for?

  • Pharma major Cipla got the Thomson Reuters India Innovation Award in 2012.
  • The company received Dun & Bradstreet American Express Corporate Awards in 2006.
  • Forbes listed Cipla in the 200 ‘Best under a Billion’ in 2007
  • Cipla got the Chemexcil Award for Excellence for exports in 1980.
  • Cipla’s ranking was third in India’s Most Reputed Brands (Pharmaceutical) list in 2015

US FDA for Albuterol used to treat breathing problems

Albuterol, also known as salbutamol, is used in the treatment of breathing problems from several ailments such as asthma and other chronic obstructive pulmonary disease. The remarkable thing is this medicine brings quick relief and reduces the patients’ breathing difficulties at the earliest. Hence, the demand of this medicine has been increasing in the wake of COVID-19.

The need of the time

Most of the infected patients of COVID-19 face shortness of breath, hence the US FDA has decided to recognise medicines like ‘Albuterol Sulfate’. This drug will be given to affected patients of novel coronavirus so that they can get relief from breathing ailments. The Mumbai-based company got the approval for Albuterol Sulfate Inhalation Aerosol 90 mcg. However, Cipla said that the drug is used for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

After getting the approval of US FDA, shares of Cipla jumped 15 per cent high and hit a fresh 52-week high on Thursday.

Immediate need for the US public

“The FDA recognises the increased demand for albuterol products during the novel coronavirus pandemic,” said FDA Commissioner Stephen M. Hahn, MD. “We remain deeply committed to facilitating access to medical products to help address critical needs of the American public”, the filing from FDA stated.

Umang Vohra, MD and Global CEO, Cipla Limited said,” Albuterol is the first generic metered dose inhaler of Proventil HFA Inhalation Aerosol ever approved by FDA in the US and Cipla’s first device-based inhalation product in the market.”

History: Cipla, born in 1935

Pharma major Cipla Ltd is one of the well-known pharmaceutical companies in India.  It was founded as ‘The Chemical, Industrial and Pharmaceutical Laboratories’ in 1935 by Khwaja Abdul Hamied in Mumbai. The name Cipla Limited came into vogue on July 20, 1984. The company has focused on its Research and Development (R&D). Hence, it has more than 1,500 pharmaceutical products. The US FDA had approved Cipla’s drug manufacturing facilities for the first time in 1985.

Generic medicines for poor

Under the leadership of the founder’s son Yusuf Hamied, the company started manufacturing generic medicines for the treatment of the people living in developing countries. Cipla achieved a unique feat by launching  Deferiprone, the world’s first oral iron chelator, in 1995. Launching new medicines of different ailments at the regular intervals is the success story of this company.

Cipla operates from various places

Currently, Cipla has spread its feet far and wide. The company has 34 manufacturing units functioning from eight locations in the country and has a presence in more than 80 countries worldwide. The total export of the company in 2019 was Rs 68 billion.

Cipla Ltd is a well-known pharmaceutical brand globally. The approval of albuterol sulfate by the Food and Drug Administration (USFDA) tells the success story of this renowned pharmaceutical company of the country.

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Cipla Gets US FDA Approval for Albuterol; What Does This Mean for India?
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Cipla Gets US FDA Approval for Albuterol; What Does This Mean for India?
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Cipla Ltd has added another feather in its cap as the US Food and Drug Administration (USFDA) has approved the company’s Albuterol Sulfate medicine to be used in the treatment of breathing difficulties amid covid-19 crisis. Read on to know how this will help Cipla to reach the global market.
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