Strides Shasun gets USFDA tentative nod for Ranitidine tablets

Strides Shasun today said it has received an approval from the US health regulator for Ranitidine tablets used for treating intestinal and stomach ulcers and gastroesophageal reflux disease.

In a BSE filing, Strides BSE 0.12 % Shasun said "it has received approval from the US Food and Drug Administration (USFDA) for Ranitidine tablets USP, 150 mg and 300 mg". The company will manufacture the product at its Cuddalore and Pondicherry facilities.

With an aim of expansion, pharma companies like Lupin and Torrent eyeing overseas acquisition

 India's top pharmaceutical companies are set to embark on an acquisition spree to bulk up their overseas presence.

Lupin BSE 0.03 % , Torrent, Zydus BSE 0.07 % Cadila, Intas, Aurobindo BSE 1.11 % , Dr Reddy's and No. 1 Sun Pharma BSE 0.16 % are said to be examining proposals of varying sizes, cherry­picking those that can fill gaps in the product range. These companies are all looking at popular brands. They are scouting for niche manufacturing sites, promising experimental drugs, specialty firms in emerging markets and opportunities in the US, Europe or Japan, putting the industry at the verge of an inflection point, experts said. At the same time, a bunch of small Indian firms are also emerging as prime acquisition targets.

The overseas companies on shopping lists include Brazil's skin care­focused Theraskin, which has attracted interest from Torrent Pharma and Lupin. While Torrent is seen placing bids for a long list of assets to catch up with its homegrown peers, Lupin has shown an appetite for snapping up acquisitions that it finds a good fit.

After taking over Gavis for a record $880 million last year, Lupin recently picked up a set of brands from Shionogi in Japan, further strengthening its hold in the world's secondlargest pharmaceutical market after the US. Lupin and Torrent did not respond to questions from ET. With an ebitda (earnings before interest, taxes, depreciation, and amortisation) of $15 million, an investment banker said Theraskin could be valued at above $200 million.

Lapses push Pfizer to shut Chennai unit temporarily

Pfizer BSE 0.63 % is the latest addition to an expanding list of drug makers found deviating from good manufacturing practices in India. In the last week of June, a high profile team drawn from world's four leading regulators identified a number of deficiencies at the company's Irungattukottai facility, near Chennai.
Pfizer has temporarily stopped production at the site. The site, which makes generic injectable drugs, is grappling with adverse reviews for a few years. It was served a warning letter by the US Food and Drug Administration (FDA) in 2013, which was followed up with a handful of observations.

Inspection was led by UK's Medicines and Healthcare products Regulatory Agency (MHRA) and included US FDA, Therapeutic Goods Administration of Australia and Health Canada, the Canadian drug regulatory agency. The New York­headquartered pharmaceutical giant informed "it temporarily paused production at the site to allow an assessment of observations by appropriate experts". It added, "Our colleagues are fully engaged and working towards resuming production as soon as possible. The temporary pause in manufacturing is being utilized to review the observations, to develop a holistic improvement plan and also to provide additional training to our colleagues at the site".

The injectables unit was formerly owned by Hospira, the injectables maker that Pfizer acquired last year as part of a global $17 billion deal. Hospira had acquired it in 2009 from Orchid Chemicals BSE ­0.76 % in a broader $400 million transaction. "A holistic plan is being developed to address specific inspection observations and to implement enhancements to site operations," Pfizer said, stating the site is dedicated for exports and does not manufacture for the domestic market. The company ruled out any impact on its employees at the site as a result of the latest inspections. The US FDA and MHRA submitted their inspection observation reports, which Pfizer said it has reviewed in depth. "The site has formally responded to both these agencies and is working diligently to address the specific inspection findings and implement enhancements to site operations," it noted.

Deals this week: Orgenesis, Advanced Accelerator Applications, Kyowa Pharmaceutical

Orgenesis INC has formed a joint venture (JV) with Atvio Biotech to provide gene and cell therapy development services.

According to the agreement, Orgenesis and shareholders of Atvio hold a 50-50 participating interest in the JV and Atvio will be responsible for providing contract development and manufacturing services for the global expansion of MaSTherCell, a wholly-owned subsidiary of Orgenesis.

Dr Reddy's acquires Teva's eight US products

Dr Reddy's Laboratories Ltd on Thursday said it has completed acquisition of eight Abbreviated New Drug Applications (ANDAs) in the US from Teva Pharmaceutical Industries Ltd and an affiliate of Allergan plc. 

Natco Pharma gets ANDA nod for Tamiflu (Oseltamivir Phosphate 30 mg, 45 mg and 75 mg)'s generic version

Natco Pharma BSE 3.85 % Ltd today said it has received final approval for its Abbreviated New Drug Application (ANDA) for generic versions of Tamiflu oral capsules (Oseltamivir Phosphate), 30 mg, 45 mg and 75 mg, from the US Food and Drug Administration.

"Natco and its marketing partner Alvogen are the first generic players to receive this approval," Natco said in a regulatory filing. Tamiflu is used to treat the flu (influenza) in people 2 weeks of age and older who have had flu symptoms for no more than 2 days. Tamiflu can also reduce the chance of getting the flu in people 1 year and older. Earlier in December, 2015, Natco and Alvogen settled a patent infringement with Gilead Sciences, Inc., Hoffmann­La Roche Inc., F. Hoffmann­La Roche Ltd. and Genentech, Inc. 

Under the terms of the settlement, Natco's partner Alvogen will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period. Tamiflu oral capsules had US sales of approximately USD 403 million for twelve months ending December 2015, according to IMS Health, Natco said. 

Clinical trials may rise as drug regulator eases rules

The federal drug regulator has eased norms related to pharmaceutical research, a move that may boost the number of clinical trials but could also raise concerns on patient safety. 

Drugs Controller General of India (DCGI), in a recent notification, said an investigator or researcher can undertake as many trials as approved by the ethics committee instead of the present cap of three. The regulator has also relaxed norms for hospitals or clinical sites undertaking such trials. Through a separate notification, the DCGI has revised the rule that prohibited any hospital with less than 50 beds to take up a trial. Under the revised norms, the ethics committee has been empowered to decide whether a site is suitable for a trial irrespective of its bed capacity. It suggested the site should have "emergency rescue and care arrangements". 

The ethics committee is a panel of experts which examines the proposal of a pharmaceutical company or a researcher to conduct clinical trials or human experiments for new medicines. Following random clinical trials and increasing number of deaths during such experiments, the government had earlier imposed a restriction of not more than three clinical trials to be conducted by an investigator. 

The number of clinical trials in India went up rapidly around 2008­09. According to data available from the Central Drugs Standard Control Organisation (CDSCO), around 65 trials were approved in 2008, whereas it jumped to 391 in 2009 and 500 in 2010. However, following the Supreme Court's intervention, the approvals dropped drastically from 2011 onwards. 

The latest changes has cheered the industry. "Ultimately what this translates into is qualitatively better clinical trials as decisions will be guided by which investigator or site is best suited for a particular trial," Indian Society of Clinical Research president Suneela Thatte said. 

NPPA's latest price cap: More cancer, HIV drugs to become cheaper

 Drug pricing watchdog National Pharmaceutical Pricing Authority (NPPA) has slashed by up to 35 per cent the prices of several essential medicines, including those to treat cancers and HIV infections. In its latest notification, the body has capped the price of antibiotic doxycycline (100mg) and revised the ceiling prices of 23 medicines already included in the National List of Essential Medicines (NLEM). 

Patients using these drugs should see a drop of anywhere between 10 per cent­ 35 per cent in the prices of these medicines, NPPA told ET. 

The list includes drugs like Melphalan (2mg) and Melphalan (5mg), which are indicated for the treatment of multiple myeloma (a type of blood cancer), cancer of the ovaries and breast cancer. Chlorambucil (2mg), another tablet used to slow the growth of certain cancer cells in the body, also figures in the list. 

NPPA has also revised the ceiling prices of antiretroviral drugs Zidovudine (300mg) and the Lamivudine (150mg) + Zidovudine (300mg) combination, which are used in the treatment of HIV infections. 

"The manufacturers not complying with the ceiling price and notes specified here in above shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955," stated NPPA in its notification dated July 30. 

By March­end, pharmaceutical companies owed NPPA dues that exceeded Rs 4,551­ crore for overcharging patients. This amount had piled up over the past two decades. 

Court charges Sun Pharma with unfair labour practices

The Mumbai Industrial Court has ruled that Sun Pharmaceutical Industries BSE 0.64 % adopted unfair labour practices by holding back salaries of 86 sales promotion employees since May after they protested planned changes in service conditions. 

In an interim order on July 29, the court directed India's largest drug maker to pay the staff and directed the company not to terminate employees without following the due procedure of law. 

The court rejected other forms of relief sought in the petition filed by a union representing the staffers, who wanted full payment with 18% interest on dues. 

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RPGLife buys Sun Pharma's seven brands at Rs 41 crore

Harsh Goenka-promoted RPG Life SciencesBSE 8.14 % has bought seven brands of Sun PharmaBSE 1.99 % at a deal value of Rs 41 crore and is expected to give RPG extra room to expand in the nearly $5 billion domestic market. 

Fosun agrees to buy KKR-backed Gland Pharma for $1.4 billion

Shanghai Fosun Pharmaceutical Group Co Ltd has agreed to buy Gland Pharma - which is backed by KKR & Co LP - for about $1.4 billion, a person with direct knowledge of the matter said, in India's largest inbound acquisition this year.

Many prohibited drugs available in markets: Ananth Kumar

As many as 439 drugs, including brands like Phensedyl and Corex which have been banned for sale and distribution, but some of them continue to be available in the markets due to the intervention of courts, Chemicals and Fertilisers Minister Ananth Kumar said today.

Kumar said in Lok Sabha that these 439 drugs, including 344 fixed dose combinations, were banned after examination of the samples of the medicines. "Many of the drug manufacturers approached various High Courts and got stay orders. Urgent and immediate persuasion is being made by the government to vacate the orders of the High Courts so that the ban on drugs could be implemented as early as possible," he said during Question Hour.

Licence for manufacturing, sale and distribution of drugs are granted by state licensing authorities appointed by respective state governments. "Manufacturing and marketing of banned drugs is a punishable offence under Drugs and Cosmetics Act and the State Licensing Authorities are empowered to take action in such cases," the Minister said.

Claris Life gets USFDA nod for generic Bupivacaine anesthetic injection

Drug firm Claris Lifesciences has received approval from the US health regulator for generic anesthetic Bupivacaine injection.

The company has received approval from the United States Food and Drug Administration (USFDA) for generic "Bupivacaine hydrochloride in 8.25 per cent dextrose injection USP 7.5 mg/mL, single dose ampules with 2 ml fill volumes," Claris Lifesciences said in a BSE filing.

The injection is indicated for the production of local or regional anesthesia or analgesia for surgery, diagnostic and therapeutic procedures.
With this approval the company has 15 approvals and 25 under approval abbreviated new drug applications (ANDAs), Claris Lifesciences said. The company expects more product approvals during the year, it added.