Pharmacy

Lupin Ltd and Natco Pharma have formed an alliance to jointly commercialize generic lapatinib ditosylate tablets used for the treatment of breast cancer in the US market. Lapatinib ditosylate tablets are sold under the brand name Tykerb in the US market. The patent of Tykerb is with Glaxo. Natco had filed an Abbreviated New Drug Application (ANDA) seeking US Food and Drug Administration (US FDA) approval for marketing generic equivalent of Tykerb® in 250 mg tablets. Lupin, the 5th largest and the fastest growing top 5 generics player in the US (by prescriptions), the only Asian company to achieve that distinction along with Natco, believes that they are first-to-file an ANDA containing a Paragraph IV certification for Lapatinib. Tykerb® had sales of $113.6 million as of March 2011 according to IMS health.

Glenmark Pharmaceuticals has recently announced that it has received final approval from USFDA for its generic mupirocin ointment, used for the treatment of skin infections. The US subsidiary of Glenmark Generics has been granted a final Abbreviated New Drug Approval (ANDA) from USFDA for mupirocin ointment USP 2 per cent, the company said in a statement. Based on IMS health data for the 12-month period ending March 2011, mupirocin ointment, used in treatment of bacterial skin infection impetigo, garnered annual sales of $55 million and achieved a 9 per cent increase in growth compared to the same period last year. The ointment is available in a 22-gram tube. The company has 39 ANDAs pending for approval and has a portfolio of 68 products for distribution in the American market.

OncoTrack, an international consortium, managed by Bayer HealthCare Pharmaceuticals and the Max Planck Institute for Molecular Genetics launched one of Europe's largest academic-industry research projects to develop a novel approach for identification of new markers for colon cancer. Their prime objective is to establish new methods for systematic next generation oncology biomarker development, with the intention to generate top quality genomic and epigenetic sequence data from clinically well- defined tumours and their metastases. The data acquired from all phases of the project will enable OncoTrack to address important questions about the relationship between tumour genotype and phenotype, the project has collaborations with leading global pharmaceutical companies, such as AstraZeneca, Bayer HealthCare Pharmaceuticals, Merck, Pfizer and Roche Diagnostics, whose in-kind contributions to the project are around € 25.8 million. Dr David Henderson, Principal Scientist – Translational ^Sciences, Bayer HealthCare Pharmaceuticals, said, "We have assembled a team of clinicians, molecular scientists, bioinformaticians more...

For   new   biologicals and   biosimilars, the innovative Spedia NMR™ technology from Spinnovation Biologies provides a real advantage for optimizing cell cultures, monitoring and standardizing manufacturing processes in preparation for larger scale production. Within the past four months, this has been validated by 37 companies developing biologies or delivering services to this industry. This premium Nuclear Magnetic Resonance (NMR) analysis service rapidly identifies a wide selection of feed components, metabolites and toxic compounds in culture media. By comparing media profiles from different cell culture batches, Spedia-NMR™ identifies how a cell consumes and metabolizes the media along the culture process. This allows the composition of the media to be fine-tuned to improve cell viability, reach highest yields of biologic product and perform rapid process troubleshooting. Talking about the value of Spedia-NMR™ in biotech companies, Dr Frederic Girard, CEO, Spin ovation, explained, "In a short term, Spedia-NMR™ will fill the gap in knowledge more...

Goose, a Hyderabad-based leading innovator of business reengineering solutions, has new    regulatory packaging guideline, detect counterfeit and protect their brand reputation. Procon™ Tracker is a new addition to Goose wide range of Procon solutions adopted by several leading global pharma companies to increase business processes efficiency. Procon™ Tracker features robust encrypted serialization and package authentication capability designed to ensure consumer safety, reduce counterfeiting & diversion and therefore meet multiple stakeholder expectations throughout the product supply chain from the point of manufacturing to consumer end. The Procon™ Tracker supports pedigree (an electronic record keeping requirement) and is capable of multi-printer interface. It also supports automated and manual lines with added competency to work offline when there are no bar code capable printers. Deb Pattnaik, Founder, Goose, said that the recent directive from the government to pharma industry to implement track and trace automatic identification process to offset counterfeits opens an opportunity more...

...says Dr Panchapagesa Murali, Managing Director and CEO, Evolva India. He was also the Founder and Director of Dalmia Centre for R&D. He holds more than 20 years of experience in pharmaceutical and healthcare R&D. He discusses the future of R&D in the Indian market. Jasleen Kaur Batra After spending considerable time at Dalmia Centre, why the switch to Evolva? Switching to Evolva from Dalmia was never about the job or opportunities; it was purely on the basis of trying to understand science and the various options it offers. At Dalmia (one of India's oldest and most distinguished business houses, which is into developing and launching natural products) we worked with natural products that were found in plants, we used whole cell plant cocktails and tried to launch a process where one may hot even know what is the active molecule or the mechanism of the action; one could only more...

As packaging lines in pharma gathers momentum/ there is an increasing need for adequate quality check to maintain the standard of products. ACG Inspection with its hi-tech systems aims to eliminate possible danger and loss. chandreyee Bhaumik Over the last four decades ACG Worldwide has been dedicated  to  providing end-to-end solutions for the pharma industry and fulfilling the requirements of over 1500 customers in more than 80 countries. It is one of the few companies globally that offers technology solutions for pharma manufacturing, packaging, security and R&D solutions, all under one roof. With globalization and increased speed of packaging lines, there is a major challenge for effective online checks to maintain product quality. Thus, ACG Worldwide addressed this requirement of the industry by establishing ACG Inspection in 2009. It is a company that aims to provide hi-tech camera systems to increase the possibilities of revenue and reputation. The group offers more...

Market overview Today, India is considered the "pharmacy of the world' as it now supplies one third of all the pharmaceutical products sold worldwide. Indian drug manufacturers attribute this success to continuous R&D on products and standardized process infrastructure. India has the largest number of FDA-approved manufacturing plants outside the US. Combined with a low cost of production, innovative scientific manpower and increased outsourcing of manufacturing processes to India, this makes Indian pharmaceuticals a powerful industry group. The sector is currently experiencing an annual growth rate of around 16%. This phase of rapid expansion is due to the anticipated loss over the next few years of patent protection on major blockbuster drugs worth US$120 billion, with Indian generic drug manufacturers planning to capture more of this market.  There are approximately 250 large units and about 8000 small-scale units that form the core of the pharmaceutical industry in India. This includes more...

A pharmaceutical company seamlessly upgraded its SAP system, enabling operators to focus on the core business of making pharma products. Concerns arose about whether existing transactions and links would work, or even exist, once the upgrade was completed. All these were answered. The goal of a SAP interface system is to alleviate manual data entry into SAP performed by production operators. The SAP interface system helps operators to request production material and product to their suite from the same terminal that is used for operating equipment. A major North American pharmaceutical company implemented its Manufacturing Execution Systems (MES) in 2005 with the help of Grantek Systems Integration, a Rockwell Automation Solution Provider. The pharma company needed to upgrade its corporate SAP system from SAP R/34.6C to SAP ECC 6.0. The focus of the upgrade was on the technical aspects and the impact on the validated systems, Testing is vital for more...

With the annual turnover (from domestic sales and exports) inching towards the $23-billion mark along with a steady double-digit growth rate, the Indian Pharma Inc never had it so good. Furthermore, according to a report by McKinsey, the country is poised to rank among the top 10 markets of the world by 2015. Amid this extensive growth and given the knowledge-intensive nature of pharma business, the strategic role of human resources cannot be overemphasized. There are multiple perspectives to this evolving success story. While the present opportunities and future prospects make a bright case for a successful career in pharma, the challenge seems to be in not only recruiting the right talent with the required experience but also retaining these resources for a reasonable time. The span of requirement ranges from workforce in research to manufacturing, marketing to supply chain management, among others. One of the key questions facing the more...