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Results For "Granules-India"

95 News Found

Granules India receives approval from Health Canada for arthritis drug
News | August 30, 2021

Granules India receives approval from Health Canada for arthritis drug

Acetaminophen extended-release tablets 650 mg is bioequivalent of the reference listed drug Tylenol


Granules India earmarks Rs 400 crore as Capex for FY 22
News | August 02, 2021

Granules India earmarks Rs 400 crore as Capex for FY 22

The company has an outlay of Rs 120-140 crore as R & D expense for FY 22


Granules India Q1FY22 consolidated net profit at Rs. 120.20 Cr
News | July 28, 2021

Granules India Q1FY22 consolidated net profit at Rs. 120.20 Cr

The company posted net profit of Rs.111.44 crores for the period ended June 30, 2020.


Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets
News | February 25, 2021

Granules India gets USFDA approval of acetaminophen, aspirin and caffeine tablets

ranules now has a total of 38 ANDA approvals from US FDA.


Granules India announces approval of Potassium Chloride ER Capsules
News | February 18, 2021

Granules India announces approval of Potassium Chloride ER Capsules

Granules now has a total of 37 ANDA approvals from US FDA (36 Final approvals and 1 tentative approvals).


Granules Life Sciences receives VAI Classification for Shamirpet facility
News | March 31, 2026

Granules Life Sciences receives VAI Classification for Shamirpet facility

The inspection is now closed, and no regulatory action has been recommended


Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR
Drug Approval | January 09, 2026

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million


Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets
Drug Approval | December 22, 2025

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia


Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements


Granules’ packaging facility in US completes FDA inspection with zero observations
News | December 05, 2025

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US