Last Updated on July 14, 2023 by The Health Master
USFDA Authorizations and Manufacturing Sites
India has achieved a significant milestone in the pharmaceutical industry, securing the highest number of market authorizations granted by the US Food and Drug Administration (USFDA).
In addition, there has been a consistent increase in the registration of manufacturing sites in India approved by the US regulator.
These market authorizations are essential approvals for Abbreviated New Drug Applications (ANDAs), allowing companies to introduce their products in the lucrative US market.
As of April 2023, Indian formulation companies hold an impressive record of 6,316 market authorizations, surpassing those of any other country.
Indian Companies Excel in Market Authorizations:
According to the latest industry data from the USFDA, Indian pharmaceutical companies have obtained 6,316 market authorizations, the highest among all countries.
This figure includes authorizations granted to India-based subsidiaries located overseas.
Notably, out of the 107 market authorizations granted for First Time Generics, Indian companies secured 41, further demonstrating the prominence of the Indian drug industry.
Consistent Growth Amidst Challenges:
Despite the challenges posed by the COVID-19 pandemic, Indian companies have experienced a steady increase in the percentage of market authorizations granted by the USFDA over the past year.
This resilience and dedication to meeting global healthcare demands have solidified India’s position as a reliable source of high-quality pharmaceutical products.
A senior official from a prominent Hyderabad-based drug company shared that the Indian pharmaceutical industry has risen above the obstacles presented by the pandemic to achieve remarkable growth.
Indian Companies Dominate ANDA Market Authorizations:
Throughout the calendar year of 2022, the USFDA granted a total of 1,181 market authorizations for Abbreviated New Drug Applications (ANDAs).
Impressively, Indian companies secured 493 of these authorizations, accounting for 41.74% of the total granted authorizations.
This marked an increase from the 36% share that Indian drug makers held in 2020, clearly indicating the upward trajectory of the Indian pharmaceutical sector in terms of its presence in the US market.
Rise in USFDA Recognized Manufacturing Sites:
Alongside the surge in market authorizations, there has also been a notable rise in the number of USFDA-recognized manufacturing sites in India.
As of April 2023, India boasts a total of 703 manufacturing sites, constituting nearly 20% of all registered manufacturing sites operating outside India.
This figure is significant considering that India exports approximately 30% of its total pharmaceutical exports to the US.
The increasing number of recognized manufacturing sites further reinforces India’s credibility as a reliable and quality-focused pharmaceutical manufacturer.
Conclusion:
India’s pharmaceutical industry has reached new heights with the highest number of market authorizations granted by the USFDA.
This achievement showcases the country’s growing dominance in the global pharmaceutical market. Indian companies have demonstrated exceptional performance and resilience, overcoming challenges presented by the COVID-19 pandemic.
Furthermore, the surge in USFDA-recognized manufacturing sites in India affirms the nation’s commitment to maintaining high standards of pharmaceutical manufacturing.
With Indian pharmaceutical exports reaching $25.4 billion in FY23, the future looks promising for the Indian pharmaceutical industry as it continues to contribute significantly to global healthcare.
Disclaimer: This article contains information derived from The Hindu Business Line. Our team utilized an AI language model, to rewrite and present the news in a unique format.
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