Elder Pharma gets Japanese approval for API facility

Elder Pharmaceuticals today said it has received approval for its manufacturing facility in Maharashtra from the Japan health ministry.

The company has received accreditation from Ministry of Health-Japan for its active pharmaceutical ingredients (API) plant at Patalganga, Maharashtra, opening up the fast growing Japanese markets for the company's products, Elder Pharma said in a statement to the Bombay Stock Exchange (BSE).

Elder is positioning itself to be an API and advanced intermediate supplier to Japanese market. This accreditation for the API plant is a step towards strengthening Elder's position as a supplier of APIs and intermediates in the Japanese market," Elder Pharma Director Alok Saxena said.

The Mumbai-based company has also developed products for the Japanese market.

"The company has developed two products going off patent in the Japanese market in 2014. One of the products is from CNS category and the second one is from GI segment," Saxena said.
The company has already filed a patent application for one of the advanced intermediates for the Japanese market and is in talks with Japanese generic companies for supply contracts, it said.
Japanese pharmaceutical market, which is valued at $69.4 billion in 2009, is the second largest pharma market in the world.

Shares of Elder Pharma were today trading at Rs 372.10 on BSE in the late afternoon trade, up by 0.57 per cent from its previous close.

Govt may cut FDI to 49 per cent in pharma industry

The Government is expected to soon take a call on slashing the foreign direct investment (FDI) limit in the pharmaceutical sector in order to bring down the prices of drugs, chiefly essential drugs. It is mulling capping the FDI in the sector at 49 per cent and routing it through the government. Currently, the FDI limit in the sector stands at 100 per cent through the automatic route.

The government fears that 100 per cent FDI will lead to uncontrolled mergers and acquisitions (M&A) by foreign drug firms, which could lead to further increase in drug prices and also cartelisation. "There is a clear indication from the PMO (Prime Minister's Office) and the health ministry to control the escalating drug prices. State governments have also complained about it. We expect to take a call on it soon. May be around the (time of) annual budget," said a senior official at the ministry of commerce and industry requesting anonymity.

The acquisition of Indian pharma companies by multinational corporations (MNCs), according to an official, was impacting the availability of low-cost medicines. The commerce ministry had proposed tightening the rules so that Indian acquisitions by MNCs flow through it and not through the automatic route.

Last year, in the second biggest acquisition of an Indian drug firm, Piramal Healthcare sold its domestic formulations business to US-based Abbot for Rs17, 353 crore ($3.7 billion) deal. In 2008, the country's largest drug maker Ranbaxy Ltd was acquired by Japan's Daiichi Sankyo for Rs21,574 crore ($4.6 billion).

India's Rs35, 175 crore ($7.5 billion) drug industry is among the world's top five bulk drug producers. It is also among the world's 20 top pharmaceutical exporters, with exports growing at 17.8 per cent per annum. India currently ranks third in terms of the volume of production (9.3 per cent of global share) and 14th in terms of value (1.5 per cent of global share).

Merck opens its new Application and Technology Centre in India

Global Pharmaceutical and Chemical Company, Merck Limited, opened its new Application and Technology Centre at Nerul, Navi Mumbai. Spread over 1700 sq. ft., the state-of-the-art Centre will enable Merck to offer customized application and technology solutions to its customers in fields ranging from drug discovery to automobile and decorative paints. Mr. Klaus Bischoff, Head of Laboratory Solutions Business Unit, Merck Millipore and Dr. Marek Dziki, Managing Director, Merck Ltd [India] officially inaugurated the new facility in the presence of senior members and guests.

"Following the acquisition of Millipore, a leading life sciences company, earlier last year; Merck Chemicals consolidated its position by covering the entire value chain for our pharma and biopharma customers, offering integrated solutions beyond chemicals. Supported by over 300 years of experience, the new Application and Technology Centre will be an ideal platform to showcase Merck's capabilities in the high growth fields of Biopharmaceutical Process Solutions, Laboratory Essentials as well as Pigments and Cosmetics for our customers in India", remarked Mr. Bischoff on the occasion.

Commenting on the sidelines, Dr. Dziki said, "Merck Chemicals offers over 15,000 products that cater to various industries which are demonstrating a double-digit growth rate, like pharmaceuticals, biotechnology, chemicals industries, academia, food and beverages, automobiles and cosmetics. In this fiercely competitive environment, customization alone is the key. With the new Application and Technology Centre, Merck will develop different formulations and new methods as per our customers' needs; thereby giving them the necessary edge over competition."

Earlier, the Indian pharmaceutical industry had been characterized by a core competency in generics' manufacturing and relatively immature capabilities in R&D. This outlook has evolved substantially since the 1990s and Indian companies have been making investments towards expanding drug discovery and development capabilities.

Mr. Prantik Mukherjee, Head - Merck Millipore, added, "The facility is equipped with state-of-the-art application, demonstration and quality control laboratories that meet stringent international standards. We will also offer resources for sales force training, for Merck as well as our customers. The aim is to anticipate and not just meet customer needs; thereby verifying our claim of being a true partner in their business. For example, with respect to our pharmaceutical and biotechnology customers, our goal is to help them reduce time to market through our products and services."

The Application and Technology Centre has 8 laboratories where Merck can create and demonstrate its customized solutions. In addition to chromatography analysis, there are laboratories for separation analysis, a critical method in the identification and separation of new chemical entities and new biological entities. Four of the labs address cosmetic actives, cosmetic pigments, printing and coating applications. These will provide technical services like colour and shade matching where market samples can be evaluated and suitable options recommended. Basic formulations and concepts for all applications and promotional demo tools for coatings, printing, packaging and cosmetics will also be provided at these labs. The lab will also undertake experiments to create new customized solutions for its customers unanticipated needs.
Besides, this Centre will open up new vistas in water and chemical analysis capabilities in India. By bringing in the cutting edge global technology and benchmark in India, Merck Millipore would provide much needed support to Industrial and public customers and help them benefit by developing customized products for both domestic and international markets. These products will be exported from India to countries across the world.

Merck is a global pharmaceutical and chemical company with total revenues of € 7.7 billion in 2009, a history that began in 1668, and a future shaped by approximately 40,000 (including Merck Millipore) employees in 64 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S.subsidiary Merck & Co. was expropriated and has been an independent company ever since.

National Pharmaceutical Pricing Authority (NPPA) slaps fine on Cipla for overpricing

National Pharmaceutical Pricing Authority (NPPA) has issued notices to Cipla for overpricing of two drugs demanding an amount of Rs 47.70 crore in respect of the drug Salbutamol and an amount of Rs 25.46 crore in respect of the drug Ciprofloxacin.

The total estimated overcharged amount, including interest, by various pharma companies since the inception of the NPPA in 1997 is a whopping Rs 2,208.35 crore. But so far, the Authority could recover a paltry Rs 202.20 crore from this and is fighting litigations in various courts with the companies to recover the rest of the sum.