IPP Bureau

Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility
Alembic Pharmaceuticals completes USFDA RRA for its bioequivalence facility

By IPP Bureau - August 29, 2022

The RRA was conducted from 22nd August, 2022 to 26th August, 2022.

USFDA completes inspection at Aurolife Pharma’s Raleigh unit
USFDA completes inspection at Aurolife Pharma’s Raleigh unit

By IPP Bureau - August 29, 2022

The unit has filed 2 Derma products and 1 MDI product.

Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP
Alembic Pharmaceuticals receives USFDA final approval for Chlorthalidone Tablets USP

By IPP Bureau - August 29, 2022

he approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Hygroton Tablets, 25 mg and 50 mg, of Sanofi Aventis US. LLC (Sanofi).

SciGenom announces Phd program in collaboration with CHARUSAT University
SciGenom announces Phd program in collaboration with CHARUSAT University

By IPP Bureau - August 29, 2022

This industry-academia collaboration will provide students with an opportunity to participate in research activities with multiple international universities and scientists

Moderna sues Pfizer, BioNTech for mRNA patent infringement
Moderna sues Pfizer, BioNTech for mRNA patent infringement

By IPP Bureau - August 28, 2022

Complaints to be filed in both United States and Germany alleging that Pfizer and BioNTech's COVID-19 vaccine Comirnaty unlawfully infringes patents Moderna filed between 2010 and 2016

Qdenga approved in Indonesia for use regardless of prior dengue exposure
Qdenga approved in Indonesia for use regardless of prior dengue exposure

By IPP Bureau - August 28, 2022

Indonesia national agency for drug and food control, BPOM, approved QDENGA for use in individuals 6 to 45 years of age

Novartis to spin-off Sandoz business to a standalone company
Novartis to spin-off Sandoz business to a standalone company

By IPP Bureau - August 28, 2022

Sandoz is planned to be incorporated in Switzerland and to be listed on the SIX Swiss Exchange, with an American Depositary Receipt (ADR) program in the US

Moderna files for emergency use of BA.4/BA.5 Omicron booster
Moderna files for emergency use of BA.4/BA.5 Omicron booster

By IPP Bureau - August 28, 2022

Pending authorization, Moderna ready to ship bivalent booster mRNA-1273.222 in September

Collective efforts needed to make India a global healthcare leader: Dr Mandaviya
Collective efforts needed to make India a global healthcare leader: Dr Mandaviya

By IPP Bureau - August 28, 2022

It is high time that India assumed a leadership role in healthcare.

Philips spotlights integrated, data-driven cardiology solutions at ESC 2022
Philips spotlights integrated, data-driven cardiology solutions at ESC 2022

By IPP Bureau - August 28, 2022

Philips AI-powered interventional and diagnostic smart systems enhances diagnostic confidence, drive greater efficiency, and improve patient outcomes

Glenmark receives OAI from USFDA for Goa facility
Glenmark receives OAI from USFDA for Goa facility

By IPP Bureau - August 28, 2022

Glenmark continues to cooperate with the US FDA and is committed to undertake all necessary steps required to address their observations at the earliest.

Cipla receives 6 observations from USFDA for Goa facility
Cipla receives 6 observations from USFDA for Goa facility

By IPP Bureau - August 28, 2022

There are no data integrity (DI) observations.

Syngene International forms a new subsidiary
Syngene International forms a new subsidiary

By IPP Bureau - August 28, 2022

The company shall be engaged in the business of manufacturing of pharmaceutical, bio-pharmaceutical and biological products of any kind

Syngene International to acquire stake in O2 Renewable Energy II
Syngene International to acquire stake in O2 Renewable Energy II

By IPP Bureau - August 28, 2022

A special purpose vehicle (SPV) formed by O2 Energy SG Pte Ltd, for generation and supply of renewable power

Aurobindo Pharma Foundation and Rotary Clubs donated 800 bicycles
Aurobindo Pharma Foundation and Rotary Clubs donated 800 bicycles

By IPP Bureau - August 27, 2022

The drive also conducted a mega health camp, cancer screening for women and men, ENT screening for children, and blood donation drive

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