#Ranbaxy launches India’s first biosimilar Infimab™ for treatment of #rheumatoid arthritis

#Ranbaxy launches India’s first biosimilar Infimab™ for treatment of #rheumatoid arthritis pic.twitter.com/7MQlHE27jq
— Press Release Watch (@PrReleaseWatch) December 1, 2014

Ranbaxy Laboratories has launched Biosimilar drug Infimab™ in India at the Indian Rheumatology Association Conference (IRACON) in Chandigarh.Infimab™, is being introduced in the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, Inc. a US and Swiss-based Biopharmaceutical Company. Infimab™ will be manufactured by Reliance Life Sciences at a facility in Mumbai. Infimab™ marks Ranbaxy's entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis.

Rajeev Sibal, Vice President & Country Head-India Region, Ranbaxy, said, "Infimab™ offers a new opportunity in the management of conditions like rheumatoid arthritis.  The product has been developed as per global standards and delivers a similar clinical outcome to the innovator. It will be available in India at a very significant discount as compared to the innovator drug. More Indian patients will get the benefit of a world-class biologic treatment."Amit Munshi, president and CEO of EPIRUS, stated, "We are delighted to partner with Ranbaxy to bring Infimab™ to India. Infimab™ represents an affordable solution for patients and may expand patient access to this important medicine."

CCI gives 10 days to #Sun Pharma and #Ranbaxy to clarify

Competition Commission of India (CCI) has ordered a public scrutiny of a proposed merger and acquisition (M&A) of multi-billion dollar Sun Pharma-Ranbaxy deal.
Sun Pharma and Ranbaxy, which had announced a $ 4-billion deal in April this year, were asked to make public details of their proposed transaction in a "prescribed format" within 10 working days.
The company has received direction vide letter dated August 27, 2014 under Section 29(2) of the Competition Act, 2002 from the Competition Commission of India (CCI) directing the company to publish the details of the proposed combination in the prescribed format within 10 working days from the date of the said letter of the CCI," Ranbaxy Labs said in a stock exchange filing this morning.
The $ 4 billion-worth deal would create the fifth- largest specialty generics company in the world and the largest pharmaceutical company in India.
This is probably the first instance where the Competition Commission of India (CCI) has ordered a public scrutiny of a proposed merger and acquisition (M&A) deal to ensure compliance to fair trade regulations.

US FDA nod for generic blood pressure drug Diovan by #Ranbaxy

U.S. Food and Drug Administration said on Thursday it had approved Ranbaxy Laboratories' generic version of Novartis AG's blood pressure drug Diovan. Current market size of Diovan in the United States is $1.7 billion and Ranbaxy can generate revenue of over $200 million from generic Diovan sales as it enjoys 180 days exclusivity for the same.
It may be noted, Sun Pharma on April 7 agreed to buy Ranbaxy in an all-share deal, worth $4 billion.

Ranbaxy completes 20 years in Russia

India’s largest pharmaceutical company, Ranbaxy Laboratories Limited (Ranbaxy) today announced that the company has completed 20 successful years in Russia.

The company established its operations in the Russian market in 1993 with the launch of its key brand, Cifran. Since then, Ranbaxy has grown to become a No. 1 player with a market share of 15.4% in the represented market segment in Russia (IMS, May 2013).

With a well-established distribution network and skilled field force, Ranbaxy today has operations in 56 regions in Russia and has built strong equity with its customers. The company has a portfolio of products covering anti-infective, cold, pain management, cardiovascular, diabetology, central nervous system, urology and dermatology segments. So far, the company has registered 51 drugs in the Russian Federation and commercialised 72 SKU’s. Ranbaxy’s leading brands in Russia includes Ketanov, Coldact, Faringosept, Cifran, Pylobact and Fenules. Last year, the company’s popular brand, Faringosept was selected as the People’s brand of choice. Another well know brand, Cifran OD was ranked by IMS as the best antibiotic launch in 2004.

On the occasion, Arun Sawhney, CEO & MD, Ranbaxy said, “Ranbaxy was one of the first pharmaceutical companies from India to set up operations in Russia. We have been providing high quality, affordable generic medicines to the citizens of Russia for the last two decades, thereby supporting the Government to bring down healthcare costs. We remain committed to the Russian market and will continue to operate from the paradigm of Quality and Patients First”.

Aman Khanna, Country Head of Russia, Ranbaxy, said,  “Over the years, Ranbaxy has established itself a preferred generic pharmaceutical company in Russia. In the coming years, we look at further expanding our product portfolio to include value added and innovator products from our parent company, Daiichi Sankyo. We are working closely in partnership with regional Governments in line with the Russia Pharma, 2020 Healthcare Plan,”

Earlier in 2011, Ranbaxy and the Government of Yaroslavl signed a Memorandum of Understanding for cooperation in the field of healthcare and medical science, which was a major milestone. As part of the program, most clinical pharmacologists and senior medical students of Yaroslavl region have been trained in Pharmacovigilance.

The Russian pharmaceutical market is estimated at around US $ 20 billion (IMS, May 2013) growing at a CAGR of around 11%. The retail/out of pocket market contributes around 66% to the total market. The Federal Government in Russia is committed towards the improvement of the pharma industry with the launch of Russian Pharma 2020 strategy under which the government is encouraging pharma players to carry out heavy local investment in infrastructure, quality improvement programmes, clinical trials hubs and training for health care professionals.

Regulatory Actions against Indian Drug Companies by US Food and Drug Administration (FDA)

US Food and Drug Administration (FDA) has taken certain regulatory actions in respect of violations or deviations of US FDA regulations applicable in that country in the cases of the following Indian Pharmaceutical companies:-

1.    M/s Ranbaxy Laboratories Ltd.,
2.    M/s Wockhardt Ltd.,
3.    M/s Hospira Healthcare India Pvt. Ltd.,
4.    M/s RPG Life Sciences Ltd.,

The Drugs Controller General (India) [DCG(I)] has taken appropriate measures to ensure that the said firms manufacture drugs in compliance with the standards and Good Manufacturing Practices prescribed for them under the Drugs and Cosmetics Rules, 1945 through the system of inspections and testing of drugs.

This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the LokSabha today


DCGI asked to check quality of drugs sold by Ranbaxy: Govt

The government has ordered the Drug Controller General of India (DCGI) to check the quality of drugs produced by Ranbaxy Laboratories and to check if the firm is following standard manufacturing norms at its various manufacturing plants.

In May this year, Ranbaxy had pleaded guilty to "felony charges" in the US Court of Maryland for manufacture and distribution of certain drugs not in conformity with the GMP regulation, which are considered as adulterated drugs as per the US law, and as a result agreed to pay a fine of $500 million.

The generic drugs at issue were manufactured at Ranbaxy's facilities in Paonta Sahib and Dewas in India.

"The DCGI has already been ordered to review the good manufacturing practices compliance of the manufacturing facilities of Ranbaxy in India as well as to ascertain the quality, safety and efficacy of drugs manufactured for the domestic market at these facilities," Minister of State of Chemicals and Fertilisers Srikant Kumar Jena said in a written reply in Rajya Sabha.

To a query whether the company is selling "some of the medicines" in the country for which it was penalised in the US, Jena said as per the US law, any drug is considered adulterated if it is not manufactured, processed, packed in conformity with the current good manufacturing practice (GMP) regulations of the US Food and Drug Administration (USFDA).

"However, as per Drugs and Cosmetic Act and Rules, in India, manufacturing of drugs not in conformity of with GMP is viewed non compliance to GMP," Jena said.

Curtsy: Business Today Dated: August 23, 2013