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<keyword id="6358777" type="General" weightage="20" keywordseo="new-delhi" source="Orion">New Delhi</keyword>, Drug maker <keyword id="46698" type="General" weightage="100" keywordseo="lupin" source="Orion">Lupin</keyword> is recalling 5,720 tubes of a cream used in the treatment of various skin conditions, such as dermatitis, eczema and psoriasis, from the US market due to a manufacturing issue, according to the US Food and Drug Administration. As per the latest Enforcement Report by the US health regulator, <keyword id="779161" type="General" weightage="20" keywordseo="lupin-pharmaceuticals-inc-" source="Orion">Lupin Pharmaceuticals Inc,</keyword> a US-based arm of the Mumbai-based drug maker, is recalling Clobetasol propionate Cream, a steroid to reduce inflammation, redness and itchiness of the skin and prevent further irritation of the skin. The affected lot has been manufactured at the company's Pithampur plant in <keyword id="6355554" type="General" weightage="50" keywordseo="madhya-pradesh" source="Orion">Madhya Pradesh</keyword> and marketed in the US market by Baltimore-based Lupin Pharmaceuticals Inc. The <keyword id="44669" type="General" weightage="50" keywordseo="usfda" source="Orion">USFDA</keyword> noted that the company is recalling the affected lot due to "Subpotent Drug: Low assay result observed during long-term stability testing". The company initiated the Class III nationwide (US) recall of the affected lot on January 23 this year. As per the USFDA, a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences". The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Lupin arm recalls 5,720 skin treatment cream tubes in US

<a href="http://www.businessinsider.in/searchresult.cms?query=cipla">Cipla</a>, India’s third largest drug maker is planning to grow even larger. The firm has now come up as the only Indian contender for <keyword id="3006685" type="UNKNOWN" weightage="20" keywordseo="Kremers-Urban-Pharmaceuticals-Inc-">Kremers Urban Pharmaceuticals Inc,</keyword> the specialty generics drug business of the $4 billion Belgian drug maker <keyword id="234060" type="COMPANY" weightage="20" keywordseo="UCB">UCB</keyword>. 
 If the Indian drug maker successfully closes the deal, which is pegged at around $1.3 billion, it will cast a shadow on Lupin's recent $880 million buyout of <keyword id="2964788" type="UNKNOWN" weightage="20" keywordseo="Gavis-Pharma">Gavis Pharma</keyword>. 
 
<a href="http://www.businessinsider.in/searchresult.cms?query=Lupin+">Lupin </a>and <a href="http://www.businessinsider.in/searchresult.cms?query=Torrent+Pharma">Torrent Pharma</a> were other Indian parties that had initially shown interest but eventually opted out. 
 
The previous year’s report has said that Kremers Urban Pharmaceuticals Inc had sales of $463 million. 
 According to industry insiders requesting anonymity, “<keyword id="6357157" type="CITY" weightage="20" keywordseo="Cipla">Cipla</keyword> is the only Indian bidder for KU but it is pitted against a few powerful private equity players. It also depends on whether Cipla is prepared to shell out a large amount in a single bid." 
 
UCB floated the divestiture of Kremers Urban last year, noting that it will help reduce its debt load, and planned to focus on its core focus areas of immunology and neurology drugs. Last November, two private equity players— Advent International and Avista Capital Partners—had jointly agreed to buy Kremers as part of an all cash deal of $1.525 billion. 
 
The deal, however, was aborted in December 2014 citing unresolved regulatory issues for approval of its methylphenidate extended-release (ER) tablets. The US FDA directed Kremers to conduct additional studies to prove equivalence to Johnson &amp; Johnson's Concerta, a drug used to treat attention deficit hyperactivity disorder. 
 
Cipla’s approach towards Kremers Urban has been termed as extremely measured by market experts, particularly given that there is no fixed time frame by which it has to be closed. "It will also test how much more is Cipla willing to go to build a strong base in the US," a sector analyst said. 
 
Over the last three years, Cipla, under a refurbished management structure, has worked on establishing its own front-end marketing presence in several of its high growth markets including the US. The company is on the road to recovery after a lull of last few years. The company's net profit rose to Rs 671 crore in the quarter to June 2015 from Rs 295 crore a year-ago. 
 
Total sales were at Rs 3,853 crore, a 46% jump from Rs 2,720 crore. The current numbers are also the reflection of Cipla's subsidiaries that got incorporated in the company. The one-time payment over the manufacturing deal with Isreal's Teva for the heart burn drug Nexium has also helped Cipla pump up its revenues. 
 Its US operations are being run by <keyword id="3006684" type="UNKNOWN" weightage="20" keywordseo="Timothy-Crew">Timothy Crew</keyword>, who is an ex-Teva hand. Kremers is expected to give Cipla an ideal jumpstart in the increasingly competitive US specialty generics market where large Indian rivals like Sun PharmaBSE -0.71 % and Dr. Reddy's are already deeply embedded. 
 
Cipla has aggressively expanded its operations in the last 18 months, setting up front-ends in more than 15 markets outside its home turf India. Some of those include Yemen, Sri Lanka, Uganda, Morocco, Algeria, the US and a few European nations. 
 
Cipla COO, Sudhanshu Priyadarshi, on company’s first quarter earnings said, "Overall, the outlook for full-year 2015-16 is strong. And we expect to have a growth rate of approximately 20% for the year. We are evaluating reinvestment options in R&amp;D, consumer healthcare and biologics, while at the same time maintaining Cipla's high standards of quality, affordability and safety." 
 
In response to questions from the Economic Times, a Cipla spokesperson said that the company does not comment on any product or partner discussions. 
 
"As a pharmaceutical company, we are constantly in discussions with multiple parties on potential collaboration opportunities - in line with our aspiration to drive access and ensure availability of high quality, affordable medicines," the statement read.

Cipla only Indian firm to bid for Kremers Urban Pharmaceuticals Inc.

Pharmaceutical major <a href="http://www.businessinsider.in/searchresult.cms?query=Novartis">Novartis India</a> reported a 600% jump in its net profit at Rs 103.82 crore for the quarter ended September 30, 2015 on the back of slump sale of its OTC division to GlaxoSmithKline Plc for Rs 109.7 crore. It had posted a net profit of Rs 14 crore a year ago. 
 
The stand-alone total income from operations of the company declined 4.4% to Rs 224.43 crore during the reported quarter, from Rs 234.79 crore in the year-ago period. 
 "Proceeds of Rs 1,09.7 crore from slump sale of the OTC division to GSK CPL has been accounted for in the quarter ended September 30, 2015 results," <keyword id="69388" type="COMPANY" weightage="20" keywordseo="Novartis">Novartis</keyword> said in a statement. 
 
In January, its board had approved a slump sale of OTC business to <a href="http://www.businessinsider.in/searchresult.cms?query=GSK+consumer">GSK Consumer</a>. 
 
According to the company, sale of company’s OTC business in India follows the divestment of Novartis AG’s global OTC business, including all of Novartis AG’s major OTC patents, trade-marks and R&amp;D assets. 
 
Its parent Novartis AG also recently agreed to create a consumer healthcare joint venture with GlaxoSmithKline in which GSK will own a 63.5% stake while Novartis will own the remaining 36.5%. 
 
Last year, another deal was signed between Novartis and GSK where GSK will acquire Swiss major's vaccine business for $7 billion, while Novartis will purchase GSK's cancer drugs portfolio. The two companies will also combine their over-the-counter drug businesses under Glaxo’s management. 
 
In April last year, Novartis had agreed to divest its global animal health business to Lilly by transferring it to Elanco India, an affiliate of Lilly. 
 
"Proceeds of Rs 86.6 crore from slump sale of the animal health division to Elanco India have not been accounted for in the quarter as the transaction is subject to legal and regulatory approvals," Novartis said in the statement. 
 
In January this year, Novartis AG completed sale of its animal-health division to Eli Lilly &amp; Co for $5.4 billion as part of the Swiss drug giant’s portfolio overhaul. 
 
The sale of the animal-health division is part of a complex overhaul of Novartis that will enable it to focus on three core businesses—pharmaceuticals, eye care and generic drugs. 
 
Of late, <a href="http://www.businessinsider.in/searchresult.cms?query=pharma">Indian pharmaceutical sector</a> has been seeing intense M&amp;A activity. In March, <a href="http://www.businessinsider.in/searchresult.cms?query=Sun+Pharmaceutical+Industries+">Sun Pharmaceutical Industries</a> completed a $3.2 billion acquisition of <keyword id="82365" type="CITY" weightage="20" keywordseo="Ranbaxy-Laboratories">Ranbaxy Laboratories</keyword> Ltd to create India’s largest drug maker, with a local market share of 10%, and the world’s fifth-biggest generic pharmaceutical firm by revenue. 
 
The deal was closed after Sun Pharma faced mounting challenges procuring approvals from authorities including the courts, capital markets regulator and anti-trust watchdogs in India and the US. Sun Pharma and Ranbaxy also overcame allegations of insider trading that cast uncertainty over the deal. 
 
Other Indian pharma firms also have been aggressively looking at acquisitions in order to gain faster and easier access to new territories, increased balance sheet strength and new drug molecules. 
 
In July, Lupin acquired Russia-based ZAO Biocom for an undisclosed amount, entering a country that will be one of the top eight markets for drugmakers by 2018. 
 
The deal followed just two months after Lupin acquired Brazil-based Medquimica Industria Farmaceutica SA. In March 2014, it also purchased Mexican ophthalmic drug maker Laboratorios Grin SA, the fourth-largest pharma company in Mexico, for an undisclosed sum. 
 
In December 2014, Aurobindo Pharma acquired US-based Natrol Inc for $132.5 million for gaining access to the latter’s nutraceutical brands in the US. In January 2014, Aurobindo bought Actavis Plc’s (now Allergan Plc) Western European businesses to gain access to products, infrastructure and a marketing set-up in seven European countries. 
 
Domestic M&amp;A activities have also been gaining traction among drugmakers as they have been trying to leverage favourable valuations. In May this year, Torrent Pharma acquired ZYG Pharma Pvt Ltd that manufactures dermatological formulations such as creams, ointments, gels and lotions. This came after its December 2013 acquisition of Mumbai-based Elder Pharmaceuticals Ltd for around Rs 2,000 crore that gave it access to Elder’s brands in women’s healthcare, pain management and nutraceuticals. 
 
In addition, <a href="http://www.businessinsider.in/searchresult.cms?query=cadila">Cadila Healthcare</a> recently emerged the front-runner to snap the generic sterile injectables business of Ahmedabad-based Claris Lifesciences Ltd. 
 
Outbound M&amp;As in the pharma sector have specifically been driven by an increasing appetite among drugmakers for acquiring firms that have approved facilities outside the country and whose products are sold in expanding overseas markets. Indian drugmakers have also been looking for intermediaries and distributors with established, large distribution and marketing networks as snapping such players would help them market own products in international geographies. 
 
The series of acquisitions has also enlivened investors’ interest in pharma companies. 
 
Over the last year, Singapore’s Temasek Holdings has invested as much as $600 million to buy stakes in Intas Pharmaceuticals, Glenmark Pharmaceuticals and Sun Pharmaceutical Industries. 
 
According to a recent study by PricewaterhouseCoopers, India is expected to be one of the top 10 pharmaceutical markets by sales and reach a value of around $50 billion by 2020. 
 
Indian pharma firms are already among the global leaders in producing generics, accounting for more than 20% of the world’s generics. According to PwC, around $70 billion worth of drugs are expected to go off patent in the US over the next three years, and India is capable of manufacturing a substantial share of the product to support the resulting generics opportunities.

Indian pharma sector is going through an interesting phase with Novartis being the latest

Healthcare major <keyword id="465560" type="ORGANIZATION" weightage="20" keywordseo="Lupin-Limited">Lupin Limited</keyword> has received in-principle approval from the Cabinet Committee of the Economic Affairs (<keyword id="56977" type="COMPANY" weightage="20" keywordseo="CCEA">CCEA</keyword>) for increasing investments in its equity capital. 
	 “We wish to inform that further Foreign Investment Promotion Board’s recommendation (FIPB) on January 28, 2015, the CCEA has approved the proposal to increase investments by foreign institutional investors (FIIs) from 33% to 49%,” the company said in a letter to the National Stock Exchange (<keyword id="6354646" type="CITY" weightage="20" keywordseo="NSE">NSE</keyword>). 
	 
	It added that the company had received its Board’s approval in November 2014, following which the company had applied to the FIPB. 
	 In another development, the company has also received the US healthcare regulator Food and Drug Administration’s (<keyword id="6354656" type="ORGANIZATION" weightage="20" keywordseo="FDA">FDA</keyword>) approval for marketing the generic drug Vancomycin Hydrochloride Capsules, 125 mg and 250 mg. The medicines are a generic version of Vancocin® capsules 125 mg and 250 mg strengths and will be sold through its US subsidiary, Lupin Pharmaceuticals Inc. (LPI). It should be noted that Vancocin® Capsules had annual U.S sales of US$ 164.2 million last year. 
	 
	Representational Image

Double Cheers For Lupin, CCEA Approves Raising
Investment In Equity Capital

Pharmaceutical major <keyword id="46698" type="CITY" weightage="20" keywordseo="Lupin">Lupin</keyword> has received approval from the United States Food and Drug Administration (<keyword id="6354656" type="ORGANIZATION" weightage="20" keywordseo="FDA">FDA</keyword>) for its generic drug capsules, 50 mg. The drug manufacturer can now market the generic form of Celebrex Capsules 50 mg by G D Searle LLC’s, which is a subsidiary of <keyword id="44612" type="CITY" weightage="20" keywordseo="Pfizer">Pfizer</keyword> Inc. 
	 
	The FDA has also granted tentative approvals to Lupin for its Celecoxib capsules 100 mg, 200 mg and 400 mg strengths. Celecoxib Capsules 50 mg, 100 mg, 200mg and 400 mg are AB rated generic version of Pfizer’s Celebrex Capsules of the same strength. The medicines are used for treating Osteoarthritis, Rheumatoid Artritis and Juvenile Rheymatoid Artritisin in patients who are 2 years or older. 
	 
	The US drug maker Pfizer had clocked in a sale of $2.44 billion through Celebrex in the US. Until recently, Indian drug makers had faced the heat when FDA had found that a major Indian pharmaceutical company was selling adulterated drugs in the market. Ranbaxy was later fined for $500 million fined $500 million (£330 million) by FDA. Following this, FDA also issued a series of import bans on Indian made products following an inspection by the US regulator. 
	 
	It should be noted that apart from Lupin, Dr Reddy Labrotaries has also announced that it will apply for approvals for two new drugs to FDA by the end of next year. 
	 
	Representational Image: Indiatimes.com

Lupin Gets FDA Nod For Generic Drug To Treat Osteoarthritis And Rheumatoid Artritis

<ul><li>Zydus Cadila said it has received approval from the Drug Controller General of India (DCGI) to initiate clinical trials for a New Chemical Entity (NCE) intended to treat Rheumatoid Arthritis (RA). </li><li>Rheumatoid Arthritis is a progressive, systemic autoimmune disease that affects at least 1 in every 100 peeple worldwide, the statement added.</li><li>Autoimmune diseases cause the body’s immune system to mistakenly attack one’s own healthy normal tissues</li></ul>Indian drug maker Cadila Healthcare— which also owns brands like Complan, Glucon D, and Nycil after the acquisition of Heinz India last year— announced that it has received an approval to conduct clinical trials in India for a new drug that may cure Rheumatoid Arthritis. 
 
 
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 Rheumatoid Arthritis is a progressive, systemic autoimmune disease that affects at least 1 in every 100 peeple worldwide, the statement added. Autoimmune diseases cause the body’s immune system to mistakenly attack one’s own healthy normal tissues. The new molecule, called ZYBK2, was discovered at the University of Michigan and Zydus Cadila acquired the rights for this molecule and conducted all the development work. The company, which currently makes most of its money from anti-infectives and cardiac drugs, has been focussing on new therapies too, especially, in medicines that cure neoplastic disease and pain. 
 
 
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 India's healing touch Cadila is one of the stocks that has taken a beating in recent weaks as exports to US come under threat. CLSA described the phenomenon as 'near capitulation'. However, Cadila may be better off than other major pharmaceutical producers like Sun Pharma, Lupin, and Cipla. "To put the underperformance into context, Sun, Cipla and Lupin have seen a big 10-20ppts decline in stock price over the last 3-6 months, whereas Abbott India, Torrent and Alkem have risen a massive 14-70% over the same period," the report said. The growth visibility is better for companies that are focussed on India (about 10-11% a year), according to the global broking firm, which highlighted that Cadila (including its consumer business), Torrent and Ipca have over 40% of revenue from India. CLSA retained its 'buy' rating on the stock and increased the target price to ₹330 recently. SEE ALSO: <a href="https://www.businessinsider.in/business/corporates/news/indian-markets-are-on-a-rebound-hoping-for-global-stimulus-to-fight-coronavirus-impact/articleshow/74451082.cms" data-type="tilCustomLink" target="_blank">Indian markets are on a rebound hoping for global stimulus to fight coronavirus impact</a> <a href="https://www.businessinsider.in/business/auto/news/between-bsvi-and-coronavirus-indian-auto-majors-like-tata-motors-and-mahindra-see-massive-dents-in-car-sales/articleshow/74435425.cms" data-type="tilCustomLink" target="_blank">Between BSVI and Coronavirus⁠— Indian auto majors like Tata Motors and Mahindra see massive dents in car sales</a> <a href="https://www.businessinsider.in/tech/apps/news/coronavirus-like-game-gets-banned-in-china-for-being-illegal/articleshow/74440408.cms" data-type="tilCustomLink" target="_blank">China bans creepy game called Plague Inc that lets players destroy the world with disease</a>

You Searched For "lupin pharmaceuticals inc" and got 6 results

Lupin arm recalls 5,720 skin treatment cream tubes in US

PTI

Cipla only Indian firm to bid for Kremers Urban Pharmaceuticals Inc.

BI India Bureau

Indian pharma sector is going through an interesting phase with Novartis being the latest

Preetam Kaushik

Double Cheers For Lupin, CCEA Approves Raising Investment In Equity Capital

Purba Das

Lupin Gets FDA Nod For Generic Drug To Treat Osteoarthritis And Rheumatoid Artritis

Purba Das

Cadila's new drug for rheumatoid arthritis gets permission for clinical trials in India

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