Sun Pharma's Halol plant gets Form 483 with 10 observations from the USFDA

 The Sun Pharma's Halol facility was classified as 'Official Action Indicated (OAI)' in March 2020, and was awaiting re-inspection from the US regulator USFDA.

The USFDA has issued a Form 483 with 10 observations after inspection of Sun Pharma's Halol facility, the company said. Halol facility, however, at present has a very low contribution to the company’s turnover.

The Halol facility was classified as ‘Official Action Indicated (OAI)’ in March 2020, and was awaiting re-inspection from the US regulator. Due to the coronavirus (Covid-19) pandemic related travel restrictions, the re-inspection got delayed, and now the USFDA has issued Form 483 with observations, which is an improvement over the OAI status.

In a notification to the stock exchanges, Sun Pharma said that the US Food and Drugs Administration (USFDA) did a...read more

Comments

Post a Comment

Popular posts from this blog

Are current inflation worries overstretched for the markets?

Image
With the economy facing inflationary pressures, concerns are mounting about its impact on markets and corporate performance. But are the fears overstretched? Is there a silver lining for investors? Record high inflation levels in India and overseas continue to dent investor confidence as disrupted supply chains due to the Russia-Ukraine crisis build up price pressures on the economy. However, an analysis of historical data shows that high inflationary environments are not necessarily unfavourable for... read more
Read more

Startup firms let Indian retail investors buy corporate debt at $130

Image
The new start ups are seeking to reassure investors they are doing all they can to protect their clients Start-up firms selling corporate bonds to retail investors are booming in India. At least 10 new financial technology platforms have sprung up during the pandemic with the aim of grabbing a share of the $1.9 trillion market for bank time deposits. They promise much higher interest rates through putting money into company bonds, which are generally seen as riskier higher-yielding debt. The firms are riding on efforts by the Reserve Bank of India to encourage retail investment in sovereign debt as... read more
Read more

Banning of crypto poses challenges: IMF chief

Image
Gopinath's comments come at a time when the government is looking to bring a Bill on cryptocurrency regulation International Monetary Fund (IMF) chief economist Gita Gopinath said on Wednesday that cryptocurrencies were proving to be a challenge for emerging markets and that strong regulation was needed for the sector. She, however, said there were practical obstacles to banning cryptocurrencies, given their decentralised nature. Gopinath’s comments come at a time when the government is looking to bring a Bill on cryptocurrency regulation. It is learnt however, that the Union Cabinet on Wednesday did not take up the Bill for consideration. With the current Winter Session ending on December 23, the chances of it being tabled in Parliament seem remote. Speaking at an event organised by National Council of Applied Economic Research (NCAER), Gopinath also said that India’s fiscal and monetary policies will both need to be accommodative for the next few quarters, given the continuing un
Read more