IPP Bureau

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

Benvic acquires specialty U.S. compounder Chemres
Benvic acquires specialty U.S. compounder Chemres

By IPP Bureau - August 27, 2022

The ninth acquisition since 2018

Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada
Jubilant receives EIR from USFDA for its radiopharmaceuticals manufacturing facility Montreal Canada

By IPP Bureau - August 27, 2022

With the receipt of the EIR, the inspection stands successfully closed.

Lupin receives UK MHRA Approval of Lutio for treatment of COPD
Lupin receives UK MHRA Approval of Lutio for treatment of COPD

By IPP Bureau - August 27, 2022

Lutio has the potential to offer significant cost savings when available to UK patients.

Lupin launches Desvenlafaxine extended-release tablets in the US
Lupin launches Desvenlafaxine extended-release tablets in the US

By IPP Bureau - August 27, 2022

Desvenlafaxine Extended-Release Tablets, 25 mg is a generic equivalent of Pristiq Extended-Release Tablets, 25 mg of PF PRISM C.V.

Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER
Granules India received ANDA approval for Guaifenesin and Pseudoephedrine Hydrochloride ER

By IPP Bureau - August 27, 2022

Granules now have a total of 51 ANDA approvals from US FDA (49 Final approvals and 2 tentative approvals).

US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad
US FDA inspection at Gland Pharma's Dundigal facility, Hyderabad

By IPP Bureau - August 26, 2022

The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.

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