Alembic Pharma to receive approval from USFDA

Company’s deals with US depend on the approval

Alembic Pharma is waiting for the final approval on the products being exported to US from US food and drug regulators Photo: Alembic Pharma
Alembic Pharma is waiting for the final approval on the products being exported to US from US food and drug regulators Photo: Alembic Pharma

The Vadodara-based drug manufacturer Alembic Pharma is awaiting final approval from US drug regulators. In the meantime, it is running exhibit batches at its Karkhadi facility (F3).

Alembic Pharma is waiting to double the number of products for which applications would be filed once the US Food and Drug Administration (USFDA) approves. Currently, the company is running exhibit batches at its Karkhadi facility to keep things moving until the USFDA’s approval comes through. 

A lot depends on the USFDA’s approval as it is critical for the company’s dealings with United States. Even though there is no fixed timeline as such on when the USFDA approval will come through, it is believed there will be more clarity within the next two months. 

The lead analyst, Bhavesh Gandhi, has said that the Karkhadi plant responses have already been made to FDA and that in the next two months, things will be clear on the subject.

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Alembic Pharma to start the operations in FY23

Like every other industry and company, the Vadodara-based company seems to have lost a lot of precious time due to the pandemic’s onset and the resulting lockdowns. 

Close to six to twelve critical months have been lost due to Covid-19. It was expected that the plant would start by the middle of FY22, but it has now been rescheduled to begin in FY23.

Changes anticipated

A lot is expected to change in the company’s business with US. The products exported by Alembic to US mainly comprise general injectables, oncology oral solids, and oncology injectables. 

It is expected that there are not many new opportunities in the future as far as oral solids are concerned and that product filings will continue to go down. Whereas in the case of oncology and injectable filings, there would be a rise enough to constitute 50% of their business dealings with US. 

Besides, the managing director of Alembic Pharma, Shaunak Amin, said that most of their US business corresponds to the oral solids plant that the FDA has approved. 

Going by the information that has been provided, Alembic seems to have lined up a set of First-to-File (FTF) opportunities in the US during the period of the next few months. These products are expected to face stiff competition from other companies. Around 20% of Alembic’s oncology business comprises of FTFs.

Alembic’s Panelav site

Both facilities that deal with active pharmaceutical ingredients in this location have been inspected by the USFDA and found to be acceptable. 

The F2 plant at Panelav that deals exclusively with oncology have two verticals – solids and injectables. Alembic is expecting an FDA inspection in the case of the F2 oncology injectables facility.

Panelav’s commissioning

The commissioning of Panelav has been pushed to FY24. Also, it is believed that the F3 facility located in Karkhadi will start expensing in FY23. Therefore, F2 commercialization at Panelav would take place after F3, and the larger part of the costs is expected to be linked to the F3 facility.

So, even though the world has already experienced the worst of the pandemic’s effects, it has been declared that virtual audits cannot and will not take the place of manual inspection of the manufacturing facilities of these medicines. In fact, you can expect to see even surprise audits of the medicine manufacturing facilities.


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