Natco Pharma's distribution partner gets tentative approval for Ibrutinib tablets

12 Apr 2021 Evaluate

Natco Pharma’s marketing and distribution partner -- Alvogen Pine Brook LLC has received tentative approval for Abbreviated New Drug Application (ANDA) Ibrutinib Tablets 560mg, 420mg, 280mg and 140mg strengths (generic for Imbruvica), from the U.S. Food and Drug Administration (USFDA).

As per industry sales data, Imbruvica (Tablet and Capsule dosage forms) had generated annual sales of $3.7 billion during the twelve months period ending December 2020 in the US market, of this, all the strengths of Imbruvica Tablets alone generated sales of $3.0 billion during the same period.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.

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