The impact of Covid-19 on API manufacturing & supply

by admin

The impact of Covid-19 on API manufacturing & supply

by admin

by admin

As an industry, we continue to adapt to the global challenges faced during the COVID-19 pandemic and it is generally known that this will be felt for some time to come in the pharmaceutical industry.

Supply concerns are leading India to invest in local production:

The closure of several factories in China following the COVID-19 outbreak has been stated to have created the need for huge changes in the pharmaceutical industry. These factories make the basic raw materials and active pharmaceutical ingredients (APIs) important to providing patients with crucial medicines on a continuous basis. These closures have had a knock-on impact on global supply during such unpredictable and challenging times.

For around 70 percent of the APIs it uses in pharmaceutical manufacturing, India depends on China. China’s coronavirus pandemic could have theoretically turned the tables on India’s $39 billion drug development sector, and numerous meetings with stakeholders were held by India’s Department of Commerce and Pharmaceuticals to promote domestic API manufacturing. In response, the Indian government has set aside $1.2 billion for the pharmaceutical industry and announced the development of a production-related incentive scheme for essential drug and API manufacturing to change the country’s dependency on China’s supply of APIs.

There is tremendous growth in the Indian pharmaceutical industry and it is projected to rise from almost $34.3 billion in 2020 to more than $45 billion by 2025. As part of its’ China-plus-one’ strategy to fill supply gaps, the country is currently undergoing the development of 53 APIs. As India is a major supplier of generic medicines worldwide, these steps are primarily aimed at ensuring and sustaining the supply of medicinal drugs. India is currently projected to remain one of the world’s fastest growing economies.

Increased containment demand and sterile product transition in development

In addition, as pharmaceutical firms continue to hurry to create new medications, including the COVID-19 vaccine, manufacturers are looking at an increased need for sterile production capabilities. They also handle more highly potent active pharmaceutical ingredients (HPAPIs), a development in the industry that has been strengthened by current conditions. In line with this the global market for HPAPIs is projected to hit USD 34.8 billion by 2025, with a rise in rapid relief therapeutics expected to fuel this demand for HPAPIs in emerging countries such as India and China over the forecast period.

In the current pharmaceutical manufacturing climate, with such a rise in the use of HPAPIs and the need for sterile manufacturing expected to continue, pharmaceutical manufacturers need to achieve efficient, validated containment and sterile transfer, a challenge. It is a highly complex job to incorporate diverse technologies supplied by multiple manufacturers into contained and sterile production lines. Known validated split valve-based solutions for the development of common interfaces between different technologies can however, provide a cost-effective and scalable validated way to create a contained environment. In the months and years to come, such technologies will be crucial in preparing the industry for higher power and sterile production.

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