Pharmaceutical Sector

NPPA slaps Rs 300-crore penalty on Novartis for overcharging

New Delhi - Drug major Novartis has been slapped with a Rs 300-crore penalty by drug regulator NPPA for overcharging consumers on sale of Voveran, its best-selling painkiller medicine.

The Swiss drugmaker, which did not confirm the quantum of the total penalty by the the National Pharmaceutical Pricing Authority (NPPA), said the notice is "erroneous and entirely misconceived".

"Novartis has received a notice from NPPA and will duly respond to the same. Novartis believes the show cause notice to be erroneous and entirely misconceived and Novartis will challenge both the basis of the demand as well as the entire quantum of the demand," Novartis India Ltd today said in a filing to the BSE.

CCI begins public scrutiny of Sun-Ranbaxy deal; seeks comments

CCI begins public scrutiny of Sun-Ranbaxy deal; seeks commentsNew Delhi - In the first-ever public scrutiny of an M&A deal in India, fair trade watchdog CCI on Thursday invited comments from all stakeholders, including general public, on finer details of USD 4-billion merger of Ranbaxy Labs into rival drugmaker Sun Pharmaceuticals.

Wockhardt drug discovery gets fast track approval by USFDA

Wockhardt drug discovery gets fast track approval by USFDAMumbai - Wockhardt today said its new drug discovery programme in anti-infective research has received a major boost after two of its drugs, WCK 771 and WCK 2349, received the Qualified Infectious Disease Product (QIDP)status from the US FDA.

This is the first instance of an Indian pharmaceutical company receiving a QIDP status, Wockhardt said in a release issued here.

Sun-Ranbaxy deal: CCI raises concerns about molecules market

Sun RanbaxyNew Delhi: The Competition Commission, which has put the multi-billion dollar Sun-Ranbaxy deal for public scrutiny, on Friday said the major issue is whether the combination would result in high market concentration of certain molecules.

"This is the first case" of combination where the Competition Commission of India (CCI) has gone for a public scrutiny, the fair trade watchdog's Chairman Ashok Chawla said.

In April this year, Sun Pharma and Ranbaxy had announced a USD 4-billion deal that would create one of the top five largest speciality generics company in the world.

Zydus Cadila gets USFDA approval for anti-viral drug Acyclovir

Zydus Cadila gets USFDA approval for anti-viral drug AcyclovirNew Delhi - Pharmaceutical major Zydus Cadila has received final approval from United States Food & Drug Administration (USFDA) for marketing of anti-viral drug Acyclovir.

"Zydus Cadila has received the final approval from the USFDA to market Acyclovir tablets," the company said in a statement issued here today.

The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, Zydus Cadila said.

Sun Pharma unit recalls mutiple lots of capsules from US

Sun PharmaHyderabad: Caraco Pharmaceutical Laboratories , a unit of Sun Pharma, has initiated a recall of multiple lots of Cephalexin capsules from the US market.

According to a notification by the USFDA, the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is voluntarily initiated by the company through a letter to the regulator in June under ?Class-II? classification.

Cephalexin is an antibiotic that belongs to the family of medications known as cephalosporins. It is used to treat certain types of bacterial infections.

Sun Pharma posts profit of Rs 1,390 cr in Q1

Sun PharmaceuticalNew Delhi : Sun Pharma Tuesday posted a consolidated net profit of Rs 1,390.51 crore for the first quarter ended June 30.

The company had posted a net loss of Rs 1,276.10 crore for the same period of previous fiscal.

Net sales of the company rose to Rs 3,926.85 crore for the first quarter, as compared to Rs 3,482.18 crore in the same period of previous fiscal, Sun Pharmaceutical Industries Ltd said in statement.

Sun Pharma-Ranbaxy deal comes under CCI scanner

Sun Pharma RanbaxyNew Delhi: Putting the multi-billion dollar Sun Pharma-Ranbaxy deal under close scrutiny, fair trade watchdog CCI has sought more information from them to ascertain whether the deal would skew fair competition in pharma sector.

Competition Commission of India (CCI) would take a final view on the deal after receiving details from them and could seek more information if it is not satisfied with the responses.

"We have sought more information from the two companies. We will take a final view after getting the required information," a senior CCI official told PTI.

Walgreens set to acquire Boots in 9 bln pounds deal

Walgreens-BootsLondon, Aug 07 : American pharmacy giant Walgreens is set to acquire Alliance Boots in a nine billion pounds deal, says a report.

Walgreens already owned 45 percent of the company's shares which it purchased in 2012 and now it will not seek the shareholder's approval to purchase the rest. The deal is expected to be hammered in the first quarter of 2015, reported the Daily Express.

Describing the merger as an important step towards becoming a global healthcare leader, Stefano Pessina, executive chairman of Alliance Boots, said that the new enterprise will represent an important milestone in the history of Alliance Boots.

Ipca Laboratories Q1 net jumps over two-fold to Rs 145.49 cr

Ipca Laboratories Q1 net jumps over two-fold to Rs 145.49 crNew Delhi: Drug firm Ipca Laboratories on Thursday reported over two-fold jump in its standalone net profit to Rs 145.49 crore for the quarter ended June 30, 2014, mainly on account of robust formulations sales.

The company had posted a net profit of Rs 71.77 crore for the corresponding period of the previous fiscal, Ipca Laboratories said in a filing to the BSE.

Standalone total income from operations of the company rose to Rs 935.96 crore for the quarter under consideration from Rs 805.56 crore for the same period a year ago.

FDA raises concern over drug production process at Cadila

FDAMumbai: The US Food and Drug Administration (FDA) has expressed concerns over the manufacturing process of at least one product at drugmaker Cadila Healthcare Ltd`s Moraiya facility, two sources with direct knowledge of the matter said.

The FDA has not expressed concerns over the entire facility, said the sources. The U. S. agency communicated its concern to Cadila in a Form 483, a letter in which the agency typically outlines violations of standard manufacturing practices.

Once the Form 483 is sent, the company has 15 days to respond before the FDA takes any further action.

Sun Pharma to seek shareholders nod for Ranbaxy acquisition

Sun-PharmaNew Delhi: Mumbai-based Sun Pharmaceutical Industries will seek shareholders nod for its USD 4 billion acquisition of Ranbaxy Laboratories in a court convened meeting on August 22.

In a filing to the BSE, the company said the meeting would be held at Vadodara on August 22, 2014.

The company said the Gujarat High Court had issued an order on July 16, directing the company to hold a meeting of its equity shareholders to consider and approve the scheme of arrangement between Sun Pharma and Ranbaxy.

Ranbaxy Q1 net loss narrows to Rs 185.92 cr

RanbaxyNew Delhi: Drug firm Ranbaxy Laboratories on Tuesday reported consolidated net loss of Rs 185.92 crore for the quarter ended June 30, 2014.

The company had posted a net loss of Rs 524.24 crore for the corresponding period of the previous fiscal, Ranbaxy Laboratories said in a statement.

Consolidated net sales of the company stood at Rs 2,372.24 crore for the quarter under consideration as against Rs 2,583.94 crore for the same period year ago.

Branded and OTC category accounted for 58 per cent of total sales during the quarter at Rs 1,370 crore. Generics and others category recorded Rs 1,000 crore of sales for the quarter, it added.

Management rejig at Ranbaxy; Arno Gessner replaces Dale Adkisson

Management rejig at Ranbaxy; Arno Gessner replaces Dale AdkissonNew Delhi: Pharma major Ranbaxy has elevated Arno Gessner to the position of global quality and compliance head after Dale Adkisson has stepped down from the post, a business newspaper has reported.

Meanwhile the company has made Alexander Gebauer as its new head of global research and development, the paper added.

The management rejig at Ranbaxy assumes significance ahead of the $4-billion merger of Ranbaxy Laboratories Ltd with Sun Pharmaceutical Industries Ltd.

Cipla appoints Adil Zainulbhai as an independent director

Adil ZainulbhaiNew Delhi: Adil Zainulbhai has been appointed as independent director on the board of drug major Cipla, the company said on Friday.

Commenting on the development, Cipla Chairman Y K Hamied said: "Adil's 30 plus years of experience across various industries in India and globally will add a valuable perspective to our Board of Directors."

Zainulbhai retired as Chairman of McKinsey India.

Earlier, he spent 24 years in the US where he led McKinsey's Washington Office and founded the Minneapolis office before returning to India.

Biocon Q1 Net up 9% to Rs 103 crore

BioconNew Delhi: Biotechnology major Biocon has reported nine percent increase in its consolidated net profit to Rs 103 crore for the quarter ended June 30.

The company had posted a net profit of Rs 94 crore during the same period of previous fiscal.

The total revenue of the company rose to Rs 742 crore for the first quarter, against Rs 723 crore during the same period of previous fiscal, Biocon Ltd said in a statement.

"Our revenue growth this quarter has been muted. Our business performance reflects the challenges that we are temporarily facing in some of our key markets, especially in the Middle East.

Glenmark Pharma Q1 Net up 43.7% at Rs 184.8 crore

Glenmark-Pharma-LtdNew Delhi: Glenmark Pharmaceuticals Thursday reported 43.7 percent jump in consolidated net profit at Rs 184.8 crore for the first quarter ended June 30, 2014.

The company had posted net profit of Rs 128.6 crore in the same quarter of the previous year.

Consolidated net sales of the company rose by 19.38 percent to Rs 1,477.8 crore during the quarter under review, as against Rs 1,237.8 crore in the same period of previous fiscal, Glenmark Pharma said in a BSE filing.

Pfizer Q1 Net dips 3% at Rs 46 cr

PfizerNew Delhi: Drug firm Pfizer Thursday reported 3.10 percent decline in net profit at Rs 46.15 crore for the first quarter ended June 30, 2014.

The company had posted a net profit of Rs 47.63 crore in the same period of previous fiscal.

Net sales of the company, however, rose to Rs 239.85 crore during the first quarter, as compared to Rs 237.53 crore in the same period of previous fiscal, Pfizer Ltd said in a filing to the BSE.

Shares of Pfizer today closed at Rs 1,412.05 apiece on the BSE, down 0.45 percent from previous close.--- PTI

Sun Pharma-Ranbaxy deal gets BSE, NSE clearance

Sun Pharma RanbaxyNew Delhi: The USD 4-billion merger of Ranbaxy Labs with Sun Pharmaceutical has got clearance from the two leading stock exchanges -- BSE and NSE.

The 'no-objection' from the two exchanges would allow the two companies to file their scheme of amalgamation with the High Court for further clearance of the deal and marks one of the numerous regulatory approvals that Sun Pharma and Ranbaxy need to consummate for the transaction.

The deal had separately come under scanner of the markets regulator Sebi for alleged insider trading violations and the present 'no-objection' from the exchanges.

Sun Pharma recalls antidepressant drug from US market

Sun PharmaHyderabad - Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma, has initiated recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market.

According to a notification by the FDA, the recall of 26,530 units of 30-count bottles and 14,597 units of 90-count bottles is voluntarily initiated by the company through a letter to the regulator last month under 'Class-II' classification.

Venlafaxine Hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder.




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