Page 11 - Pharmaceutical

Claris Lifesciences receives US FDA approval for flumazenil injection

The approved product, which is primarily used to help reverse anaesthesia effect, is estimated to have market size of $ 4 million in the US

Claris Injectables receives five 483s from US FDA for plant in Ahmedabad

The company received 483s after US FDA's inspection, classified as prior approval inspection (PAI), which was conducted from August 16 to August 26, 2016

NPPA launches mobile App to provide real time drug prices

In the last two and a half years, National Pharmaceutical Pricing Authority (NPPA) has brought almost 900 formulations under the price control

PPP model can make India one of top 5 global pharma innovation hubs: Study

Government's decision to allow 100% FDI under automatic route in the pharma sector will further enhance R&D activity in India, says a joint study of Assocham and TechSci Research

Department of Pharma consults stakeholders on pricing mechanism for stents

The move aims to develop a science, safety and efficacy based price determination process for drug eluting stents, which have been recently included in NLEM (National List of Essential Medicine)

US FDA grants approval to Jubilant's hypertension drug felodipine

The approved product, felodipine extended-release tablet (2.5 mg, 5 mg, and 10 mg), is the generic version of Plendil tablets of AstraZeneca

US patent office invalidates 2 patents of Teva's blockbuster drug Copaxone

The rule is in favour of Mylan, who has partnered with Natco Pharma in challenging the patent of the multiple sclerosis drug, Copaxone 40 mg injection, which has annual US sales of $3.3 bn

European drug regulator accepts Mylan & Biocon application for biosimilar trastuzumab

This is the second biosimilar developed by the two companies - who are collaborating for a broad portfolio of biosimilars and insulin analogs - that has been accepted for review in Europe

Perrigo acquire US distributor of healthcare products Geiss, Destin & Dunn

Acquisition will further strengthen Perrigo's US distribution and retail network, providing it direct access to the non-mass retail market

Pfizer to acquire oncology specialist Medivation for $ 14 bn

The addition of Medivation will strengthen Pfizer's position in oncology, one of its key focus areas to drive growth in the long-term

Lupin receives CDSCO approval for indigestion drug acotiamide

The current market for plain gastrointestinal (GI) prokinetics and combinations is estimated to be around Rs 2,640 crores growing at 14 percent, according to IMS Health

Tamil Nadu pharmacy traders approach Court against online pharmacies

Tamil Nadu Chemists and Druggists Association (TNCDA), an affiliate of the trader's organisation All India Oranisation of Chemists and Druggists (AIOCD), has filed a petition with the Madras High Court seeking the Department of Health and Family Welfare, Government of India and the drug regulators to block all websites in the country selling prescription medicines till the license are granted to them to sell medicines through online. The Association, which has over 30,000 members in retail and wholesale pharmaceutical trade in the State, also said that it has to be heard by the government before enacting any new law related to online pharmacy.When the matter came up for hearing, along with a public interest litigation related to online pharmacy, the Assistant Solicitor General informed the Court that the report of the Committee appointed to look into the regulations for online pharmacy is still under formulation and will be placed before the Government within four weeks.Based on ...

Piramal Enterprises buys US-based Ash Stevens to tap high potency APIs market

The company will buy the US-based contract development and manufacturing organisation (CDMO) for a total consideration of $ 42.95 million (about Rs 286 crores)

Lonza buys InterHealth Nutraceuticals for $ 300 million

Acquisition will strengthen Lonza's specialty nutritional ingredients portfolio

US FDA issues establishment inspection report for Natco's Kothur facility

The Kothur facility predominantly caters to regulated international markets, including USA

Cipla names Umang Vohra as MD & Global CEO

The current incumbent, Subhanu Saxena will step down from his position on August 31, 2016. The company also announced that Samina Vaziralli will become executive vice-chairman

Lupin receives US FDA for electrolyte replenisher

The approved product, potassium chloride extended-release tablet, is a generic version of Upsher-Smith Labs' Klor-Con tablet

Sun Pharma extends patient support program for cancer drug in US

Started as part of the imatinib mesylate launch in February 2016, the program is aimed at delivering greater access to the drug to patients

Natco Pharma receives US FDA approval for generic Tamiflu capsules

Tamiflu oral capsules (Roche's trade name for oseltamivir phosphate) had US sales of about $ 403 million for twelve months ending December 2015, according to IMS Health

Dr Reddy's completes acquisition of product portfolio from Teva

The combined sales of the branded versions of these products in the US is about $ 3.5 billion MAT for the most recent twelve months ending in June 2016, according to IMS Health