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1240 News Found

Lupin receives tentative approval from USFDA for Drospirenone Tablets
Drug Approval | November 07, 2022

Lupin receives tentative approval from USFDA for Drospirenone Tablets

Drospirenone Tablets (RLD Slynd) had estimated annual sales of US $141 million in the US


SRL Diagnostics inaugurates an upgraded laboratory at Gurugram
Clinical Trials | November 03, 2022

SRL Diagnostics inaugurates an upgraded laboratory at Gurugram

The laboratory is equipped to perform high-volume diagnostic testing services


Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program
Drug Approval | November 01, 2022

Ashland injectable pharmaceutical excipient accepted into FDA Novel Excipient Review Pilot Program

The voluntary program is the first time the FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations.


Aptar Pharma completes Phase I global injectables expansion program
News | November 01, 2022

Aptar Pharma completes Phase I global injectables expansion program

The expansion program includes investments in France and the U.S., adding an additional 23,000+ m² of manufacturing footprint.


USFDA issues Form-483 for Lupin's Nagpur Unit-2
Drug Approval | October 31, 2022

USFDA issues Form-483 for Lupin's Nagpur Unit-2

The company is committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the US


USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility
News | October 31, 2022

USFDA determines inspection classification of Jubilant Pharmova's Roorkee facility

The company currently supplies one product to the US market that contributes low- single digit revenue to Jubilant Pharmova revenue


Laurus Labs planning Rs. 2,000 Cr Capex
News | October 27, 2022

Laurus Labs planning Rs. 2,000 Cr Capex

On the Capex front, the company has invested Rs. 416 crore in the first half and it is broadly in line with our guidance for the two years around Rs. 2,000 crore across all the subsidiaries and divisions


USFDA approves Imjudo in combination with Imfinzi for liver cancer
Drug Approval | October 26, 2022

USFDA approves Imjudo in combination with Imfinzi for liver cancer

Approval based on HIMALAYA Phase III trial results which showed single priming dose of Imjudo added to Imfinzi reduced risk of death by 22% vs. sorafenib


Lupin launches Paliperidone Extended-Release Tablets in US
News | October 21, 2022

Lupin launches Paliperidone Extended-Release Tablets in US

Paliperidone Extended-Release Tablets (RLD Invega) had estimated annual sales of US $112 million in the US