Business EconomyPosted at: Oct 7 2026 1:59PM


Granules India files Paragraph IV certification for Ruxolitinib ER tablets

Hyderabad, Oct 7 (UNI) Granules India Ltd on Wednesday announced that it has submitted a Paragraph IV certification in connection with its abbreviated new drug application (ANDA) for Ruxolitinib Extended-Release Tablets, and believes it may be eligible for first-to-file status in the US, subject to review and determination by the US Food and Drug Administration (FDA).
In a release, the Hyderabad based company said it has provided the required notice to the relevant parties in accordance with applicable US regulatory requirements.
Based on the timing and status of its ANDA and Paragraph IV certification, Granules India believes it is eligible for first-to-file status for Ruxolitinib Extended-Release Tablets.
If confirmed by the FDA and subject to all applicable statutory and regulatory requirements, first-to-file status may provide eligibility for 180 days of generic drug exclusivity under US law.
The ANDA remains subject to FDA review and the company clarified that the announcement should not be construed as FDA approval of the product or confirmation by the FDA of first-to-file status or exclusivity.
Granules India Chairman and Managing Director Dr Krishna Prasad Chigurupati said first-to-file opportunities were an important part of the company's strategy to build a differentiated and higher-value product portfolio in the US.
He said the filing reflected the company's focus on identifying technically and commercially attractive opportunities where its development and manufacturing capabilities could create sustainable value.
The company said it would provide further updates, as appropriate, in accordance with applicable disclosure requirements.
UNI KNR ARN
Tags: #Granules India files Paragraph IV certification for Ruxolitinib ER tablets
More News

Stock Markets end lower for 2nd session, Nifty below 22,200

08 Oct 2026 | 6:36 PM

New Delhi, Oct 8 (UNI) Indian Stock Markets ended lower for the second consecutive session today, with Nifty falling below 22,200 in intraday to hit a fresh 52-week low amid broad-based selling, led by IT stocks, and weak rupee also impacted the market sentiment.

see more..

India eyes $1 trillion exports despite weak global trade growth: Piyush Goyal

08 Oct 2026 | 3:48 PM

New Delhi, Oct 8 (UNI) Commerce and Industry Minister Piyush Goyal said India is confident of achieving its $1 trillion export target this year, despite subdued global trade growth and heightened uncertainty in the international economy.

see more..

Adani Energy Solutions buys Satara Power Transmission from PFC Arm

08 Oct 2026 | 3:39 PM

Mumbai, Oct 8(UNI) Adani Energy Solutions Ltd, which emerged as the successful bidder, purchased a special purpose vehicle (SPV) called Satara Power Transmission Ltd (SPTL) from PFC Consulting, which is owned by state-owned Power Finance Corporation (PFC) for approximately Rs 19.01 crore, according to a stock exchange filing.

see more..

IT loses dominance in Bengaluru office market as GCCs drive demand: Brigade

08 Oct 2026 | 3:08 PM

Bengaluru, Oct 8 (UNI) Bengaluru's office market is undergoing a structural shift, with traditional IT and IT-enabled services losing their dominance to Global Capability Centres (GCCs), even as demand for office space remains robust, Brigade Group Chairman MR Jaishankar said on Thursday.

see more..

Weak monsoon impact on rural India eases as economy diversifies: RBI Report

08 Oct 2026 | 3:00 PM

New Delhi, Oct 8 (UNI) India’s rural economy is becoming increasingly resilient to weak monsoons, with a growing contribution from non-farm employment, allied agricultural activities and improved irrigation reducing the impact of rainfall shocks on rural incomes, the Reserve Bank of India (RBI) said.

see more..