Alembic gets USFDA nod for generic drug

Alembic Pharmaceuticals on Friday said it has received approval from the US health regulator to market a generic medication for the prevention of heart attack and stroke. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Ticagrelor Tablets, 90 mg and tentative approval for Ticagrelor Tablets, 60 mg, Alembic Pharma said in a statement.

The company’s approved ANDA is therapeutically equivalent to AstraZeneca Pharmaceuticals’s Brilinta Tablets, 60 mg and 90 mg, it added.

Ticagrelor tablets are indicated to reduce the risk of cardiovascular (CV) death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome.

For Ticagrelor Tablets, 90 mg, Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, the drug firm said.

According to IQVIA, Ticagrelor Tablets (90 mg) have an estimated market size of USD 1,062 million for twelve months ending March 2025.

Ticagrelor Tablets, 60 mg have an estimated market size of USD 242 million for twelve months ending March 2025.

Alembic shares were trading 0.03 per cent down at Rs 876.10 apiece on BSE.

Related Posts

  • Pharma
  • July 24, 2025
  • 239 views
Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

Natco Pharma shares slipped 2.5% to Rs 1,009 apiece on the BSE in Thursday’s trade after the company announced its plan to acquire a 35.75% stake in South Africa-based Adcock…

  • Pharma
  • July 22, 2025
  • 309 views
DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

The Directorate General of Foreign Trade ( DGFT ) has notified an extension in the deadline for submitting applications for the export of Pharma Grade Sugar. This was communicated through Trade Notice…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantra

10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantra

DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

Bihar Healthcare is poised to be embraced by Robotic Surgery Mantra

Bihar Healthcare is poised to be embraced by Robotic Surgery Mantra