5 Minutes Read

Lupin’s Vizag facility gets inspection closure report from USFDA

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

 Listen to the Article (6 Minutes)

Summary

It informed stock exchanges of “the receipt of the establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) after closure of the inspection for its Vizag (Vishakhapatnam), India facility.”

Pharma major Lupin on Thursday said that its facility in Vizag, Andhra Pradesh, has received the inspection closure report from the US health regulator.

The inspection for the facility was conducted by the United States Food and Drug Administration (USFDA) during January 13-17, the company said.

It informed stock exchanges of “the receipt of the establishment inspection report (EIR) from the United States Food and Drug Administration (USFDA) after closure of the inspection for its Vizag (Vishakhapatnam), India facility.”

“We remain committed to enhancing compliance and quality standards at the Vizag facility and across all our manufacturing sites,” Nilesh Gupta, Managing Director, Lupin said.

The company’s shares were trading at Rs 848 apiece on BSE in morning trade, 0.98 per cent from the previous close.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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today's market

index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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 5 Minutes Read

Alkem Labs gets EIR from USFDA for St Louis facility in US

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The inspection was conducted by the USFDA from January 27, 2020 to February 6, 2020, it had said in an earlier filing.

Drug firm Alkem Laboratories on Tuesday said the US health regulator has issued an establishment inspection report (EIR) for its St Louis facility in the US.

The 63 has issued an EIR for the St Louis plant and the inspection has now been closed by the regulator, Alkem Laboratories said in a filing to the BSE.

The inspection was conducted by the USFDA from January 27, 2020 to February 6, 2020, it had said in an earlier filing.

At the end of the inspection, the company had received Form 483 with three observations and had said it shall submit to the USFDA within the stipulated timeline, a detailed response to close out all the observations associated with this inspection.

Shares of Alkem Laboratories were trading at Rs 2,576.60 per scrip on the BSE, down 0.88 per cent from the previous close.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

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Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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today's market

index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Biocon Biologics receives EIR from USFDA for 2 manufacturing facilities

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The inspection was conducted between September 10 and September 19, 2019, a company spokesperson said, adding, Biocon Biologics has responded to the regulator on the eight observations from this inspection, in October last year.

Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., said on Thursday it has received the Establishment Inspection Report (EIR) from the USFDA (the United States Food and Drug Administration) for the pre- approval inspection at two of its biologics manufacturing facilities in Bengaluru.

The inspection was conducted between September 10 and September 19, 2019, a company spokesperson said, adding, Biocon Biologics has responded to the regulator on the eight observations from this inspection, in October last year.

Subsequently, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the USFDA in 2019.

“The receipt of the EIR indicates a successful closure of the inspection,” the spokesperson said. “The formal closure of the USFDA inspection is expected to enable filing of marketing authorisation applications for our biosimilar products in several global markets.”

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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today's market

index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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 5 Minutes Read

Lupin’s Mandideep Unit II facility receives EIR from USFDA

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Summary

The inspection at the facility was carried out by the US Food and Drug Administration between November 26, 2018, and December 4, 2018.

Pharma major Lupin on Wednesday said it has received an establishment inspection report (EIR) from the US health regulator for its Mandideep Unit II facility in Madhya Pradesh.

The inspection at the facility was carried out by the US Food and Drug Administration between November 26, 2018, and December 4, 2018.

In a filing to BSE, the company said Lupin has received the EIR after closure of the USFDA inspection of its Mandideep Unit II facility, classifying the inspection as “Voluntary Action Indicated.”

“We are pleased to have received the EIR for our Mandideep Unit II facility, our important cardiovascular active pharmaceutical ingredients (API) manufacturing facility,” Lupin Managing Director Nilesh Gupta said.

The company develops and commercialises a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the US, India, South Africa and across Asia Pacific, Latin America, Europe and Middle-East regions.

The shares of Lupin Ltd were trading at Rs 851.70 a piece on BSE in morning trade, up 3.12 per cent from the previous close.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

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KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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today's market

index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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 5 Minutes Read

Lupin gets EIR from USFDA for Nagpur plant

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

 Listen to the Article (6 Minutes)

Summary

The US Food and Drug Administration (USFDA) issues an EIR to a company when an inspection is satisfactorily closed.

Drug maker Lupin on Monday said it has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing plant in Nagpur.

The US Food and Drug Administration (USFDA) issues an EIR to a company when an inspection is satisfactorily closed.

The health regulator had inspected the the company’s Nagpur manufacturing facility between January 6 and January 10, 2020, Lupin Ltd said in a statement.

“We are very happy to have received the EIR for our Nagpur facility, our largest and most advanced oral solid dosage facility. We remain committed to enhancing compliance and quality standards across all our manufacturing sites,” Lupin Managing Director Nilesh Gupta said.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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today's market

index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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 5 Minutes Read

Getting ‘voluntary action indicated’ status for Malaysian unit a key development, says Biocon’s Kiran Mazumdar Shaw

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

 Listen to the Article (6 Minutes)

Summary

Our public health system has to be improved and there is a lot of opportunity for us to build a very robust healthcare ecosystem, said Kiran Mazumdar Shaw, CMD, Biocon.

The USFDA has issued Establishment Inspection Report (EIR)  with ‘voluntary action indicated’ status to Biocon’s Malaysian unit in terms of production of Glargine.

Sharing further details CMD of the company Kiran Mazumdar Shaw said, “This is an important EIR that we have received and it is a good because it makes us feel confident that we will get the approval sooner than later.”

In terms of the timeline, she said, “We have always said that it will be in the first half of this year. So, that is what we stick by.”

With this entire COVID-19 crisis one does not know when the US markets will open for business. So we have to be a bit realistic, she said, adding that they were glad the inspection went well.

“I hope that we get the approval soon but in terms of the launch, we have to be realistic because we need to wait and watch and see how things progress because the US is going through a very bad phase,” she said in an interview with CNBC-TV18.

When asked about the market size, Mazumdar-Shaw said, “Post COVID-19, there will be a huge effort to bring down healthcare costs and biosimilars are certainly going to be extremely important in this effort. I believe insulin therapies are also going to play a very important role in cost cutting and biosimilar glargine, insulins and others are going to be extremely important.”

“So, we do have an opportunity to play very strongly in this segment. It is a USD 7 billion business globally and in US itself, it is a USD 4 billion business. So from that point of view, it has a huge opportunity and it is growing. With biosimilars, the access to insulin glargine is much larger. We have a very important role to play in providing affordable access to glargine,” she said.

When asked if the number of private labs conducting COVID-19 tests would be extended and the challenges that the industry is facing in India, she replied, “Including the private labs has been a very good move on part of the government. It should have been done sooner than this. The challenge is that state government’s legislations are coming in the way. The kit issue is being resolved because a number of kits are now being produced and I don’t think we will have an issue with number of kits, as more kits are being approved.”

“The biggest worry is the way state governments are restricting private labs from testing. In Karnataka, we have cleared the way. Maharashtra has become extremely difficult. All the state governments, Maharashtra, Telangana, Gujarat, West Bengal, they have come on very heavily on to private labs. If you don’t allow private labs to test large numbers, you are defeating the purpose of including private labs into this testing arena,” she cautioned.

Talking about their biologics business target of around USD 1 billion by FY22, she said, “It is two years away. We are hoping that our business will go according to plan. There has been a lull right now because of logistics issues. I am hopeful that the COVID-19 crisis will pass sooner than later. We will work towards that target but more than anything else, this is a time for biosimilars to have a huge impact on global healthcare and that is why I remain very confident that we will have a very big role to play.”

“There is a very close cooperation going on between the government, the Centre and the private sector whether it is on the research front, whether it is on the private testing front etc. I am very pleased with that. We are all working towards developing vaccines, therapies and new antibody based serological testing, so there is a lot of that kind of work going on,” she said, adding that what COVID-19 crisis has shown us is that we have to focus on these very important areas. Infectious diseases have been neglected and ignored for too long.

“Moreover, our public health system has to be improved and there is a lot of opportunity for us to build a very robust healthcare ecosystem,” she stated.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

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Oil Fluctuates as Traders Assess China’s Vow, Unrest in Libya

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today's market

index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
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Should Elon Musk be able to buy Twitter?

 5 Minutes Read

Strides Pharma Science receives EIR for Bengaluru facility from USFDA

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

 Listen to the Article (6 Minutes)

Summary

USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.

Strides Pharma Science Ltd on Monday said it has received Establishment Inspection Report (EIR) for the inspection conducted by the USFDA in January 2020 at company’s flagship facility KRS Gardens, Bengaluru.

The inspection by the US Food and Drug Administration (USFDA) was related to specific extended release applications made from the site. Receipt of EIR confirms the successful closure of the inspections, Strides Pharma Science said in a regulatory filing.

USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection.

“The flagship facility in Bengaluru is the largest manufacturing facility for the company with capabilities to produce finished dosage formulation products across multiple dosage formats including tablet, capsules, ointments, creams and liquids,” it added.

The facility is also capable of manufacturing complex formulations of extended release tablets which is one of the focus areas for the company.

Strides has a large extended release portfolio for the US and other regulated markets with a capability to manufacture these products at multiple sites.

The company had recently also received EIR for Bengaluru facility from USFDA for the inspection conducted in March 2020, it added.

Elon Musk forms several ‘X Holdings’ companies to fund potential Twitter buyout

3 Mins Read

Thursday’s filing dispelled some doubts, though Musk still has work to do. He and his advisers will spend the coming days vetting potential investors for the equity portion of his offer, according to people familiar with the matter

 Daily Newsletter

KV Prasad Journo follow politics, process in Parliament and US Congress. Former Congressional APSA-Fulbright Fellow

Previous Article

Oil Fluctuates as Traders Assess China’s Vow, Unrest in Libya

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Shanghai residents turn to NFTs to record COVID lockdown, combat censorship

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today's market

index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -72.15
sensex ₹1,882.60 +28.30
nifty IT ₹2,206.80 +30.85
nifty bank ₹1,318.95 -14.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95
index Price Change
nifty 50 ₹16,986.00 -7.15
sensex ₹1,882.60 +8.30
nifty IT ₹2,206.80 +3.85
nifty bank ₹1,318.95 -1.95

Currency

Company Price Chng %Chng
Dollar-Rupee 73.3500 0.0000 0.00
Euro-Rupee 89.0980 0.0100 0.01
Pound-Rupee 103.6360 -0.0750 -0.07
Rupee-100 Yen 0.6734 -0.0003 -0.05
Quiz
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Question 1 of 5

What coins do you think will be valuable over next 3 years?

Answer Anonymously

Should Elon Musk be able to buy Twitter?