Approvals News

Market

High drug approvals to keep up pricing pressure for pharma firms

Competition and price erosion have triggered a rethink among firmsFilings for drug approvals slowed in October and November

1 min read19 Jan 2019
Market

Cipla Q1 results: Costs and US recovery vital for FY19 health

Cipla's success in getting new approvals does lend confidence to its view that US sales will ramp up

2 min read9 Aug 2018
Market

Cipla Q4 FY18 results no reason to reverse stock underperformance

The US generics pain is unlikely to subside anytime soon despite optimistic commentary from Cipla due to the growing number of USFDA approvals

2 min read23 May 2018
Industry

Zydus Cadila gets USFDA nod for cardiac drug

Zydus Cadila has received final approval from USFDA to market Metoprolol Succinate extended-release tablets USP

1 min read26 Mar 2018
Industry

Cipla gets USFDA observations for its Goa plant

Cipla says at this stage it does not foresee any impact on the other products being manufactured or filed from the Goa plant

1 min read20 Mar 2018
Market

Sun Pharma drops the ball again at Halol plant

Sun Pharma, for its Halol plant, got another form 483, which is issued when USFDA finds lapses in compliance, with three observations

1 min read26 Feb 2018
Industry

NPAs: RBI blames investment banks for faulty loan appraisals

Faulty project appraisals has led to the piling up of huge non-performing assets (NPAs) in India's banking sector, says RBI in its Financial Stability Report

2 min read22 Dec 2017
Companies

National Pharmaceutical Pricing Authority eases norms for new drug approvals

NPPA says in office memorandum that price approval of new drugs won't be linked to Integrated Pharmaceutical Database Management System in move seen as major relief to pharmaceutical firms

3 min read21 Dec 2017
Opinion

Permissionless innovation

It is easier to apologise than to get permission

4 min read21 Nov 2017
Companies

Bayer to Qualcomm suffer as EU makes time stand still on big M&A

Aside from the delays, companies face astronomical costs meeting the EU's requests for hundreds of thousands of internal documents, such as corporate emails

5 min read12 Nov 2017
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