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Results For "manufacturing-facility"

648 News Found

IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr
News | November 15, 2022

IOL Chemicals and Pharmaceuticals Q2FY23 net profit drops to Rs 15.6 Cr

The company registered with REACH Certificate for Ethyl Acetate with a tonnage band of more than 1000 TPA


Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Drug Approval | November 09, 2022

Zydus receives USFDA approval for Bisoprolol Fumarate and Hydrochlorothiazide Tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India


Zydus receives EIR with VAI from USFDA for Moraiya facility
Drug Approval | November 08, 2022

Zydus receives EIR with VAI from USFDA for Moraiya facility

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)


Balaxi Pharmaceuticals delivers strong growth in Q2 FY23
News | November 07, 2022

Balaxi Pharmaceuticals delivers strong growth in Q2 FY23

Revenue is up 23% whereas Profit After Tax expands 29% for the company


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


USFDA issues Form 483 for Parawada unit of Laurus Labs
Drug Approval | October 30, 2022

USFDA issues Form 483 for Parawada unit of Laurus Labs

The observation is procedural in nature and the company will address the observation within stipulated timelines.


Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets
Drug Approval | October 27, 2022

Zydus gets USFDA’s approval for Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Tablets are indicated to relieve moderately severe pain, usually after surgery.


USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
Drug Approval | October 27, 2022

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.