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www.expresspharmaonline.com FORTNIGHTLY INSIGHT FOR PHARMA PROFESSIONALS
16-30 September 2010  
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Profiles of pharma companies in Andhra Pradesh

Express Pharma profiles some of the top pharma firms from Andhra Pradesh that have made a noteworthy mark in the domestic as well as the international markets by way of exporting bulk drugs and formulations

Dr Reddy's Laboratories

Established in the year 1984, Dr Reddy’s Laboratories (DRL) is an emerging global pharma company in Andhra Pradesh. The company is moving ahead with a purpose of providing affordable and innovative medicines through three core businesses—pharmaceutical services and active ingredients, global generics and proprietary products.

Today, DRL has grown into India's second-largest pharma company. Headquartered in Hyderabad, it manufactures active pharmaceutical ingredients (APIs) and finished dosage forms and markets them globally, and also conducts basic research in diabetes, cardiovascular etc.

Recently, the company launched 'Cresp’, the first generic darbepoetin alfa in the world, and the only darbepoetin alfa in India. Cresp has been approved in India for the treatment of anaemia due to chronic kidney disease and anaemia due to chemotherapy.

Darbepoetin alfa is a modified version of epoetin alfa (rHuEPO), which is engineered to have a longer half life, increasing the time it remains in the blood. This results in a reduced frequency of doses, providing a simpler and more convenient treatment option for patients and physicians as compared to treatment of anaemia with epoetin, which is the current standard of care in India.

Aurobindo Pharma

Aurobindo Pharma is a manufacturer of generic pharmaceuticals and APIs. Based in Hyderabad, its significant products are antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals and anti-allergics. Aurobindo is among India's top five pharma companies in the country.

Founded in 1986 by P V Ramaprasad Reddy, K Nityananda Reddy and a small, highly committed group of professionals, the company became a public venture in 1992. It commenced operations in 1988-89 with a single unit manufacturing semi-synthetic penicillins (SSPs) at Pondicherry and is now a market leader.

Aurobindo went public in 1995 by listing its shares in various stock exchanges in the country. It has a presence in key therapeutic segments like SSPs, cephalosporins, antivirals, CNS, cardio-vascular, gastroenterology, etc.

Over the years, Aurobindo has evolved into a knowledge driven company. It is R&D focused, has a multi-product portfolio with multi-country manufacturing facilities, and is becoming a marketing conglomerate across the world.

Aurobindo has created a name for itself in the manufacture of bulk actives, its area of core competence. After ensuring a firm foundation of cost effective production capabilities and a clutch of loyal customers, the company has entered the high margin speciality generic formulations segment, with a global marketing network.

The formulation business is systematically organised with a divisional structure, and has a focused team for each key international market. The company believes in gaining volume and market share in every business/segment it enters.

Aurobindo has invested significant resources in building a mega infrastructure for APIs and formulations to emerge as a vertically integrated pharma company. Its five units for APIs and four units for formulations are designed for the regulated markets.

Matrix Laboratories

Matrix Laboratories, is a public limited company manufacturing APIs and solid oral dosage forms based in Secunderabad, apart from contract research and manufacturing. Important products from the company are anti-bacterials, CNS agents, antihistamines, antiasthmatics, antivirals etc.

The development and manufacture of quality intermediates and bulk actives have been critical to the success of the company in delivering innovative and affordable products for both domestic and international markets.

With about 3,000 employees, including over 200 R&D scientists, Matrix conducts R&D, and manufactures products at the company's cGMP facilities located near Hyderabad and Visakhapatnam, India. The company's Solid Oral Dosage Forms facility is located near Nashik, about 150 km from Mumbai.

The company's focus on quality, safety, environment and occupational health is pronounced and some of its plants are approved by regulatory agencies such as US-FDA, EDQM -EU, TGA (Australia) and some of the largest multinational pharma companies.

Matrix follows its core values of mutual respect, attitude, teamwork, responsibility, innovation and excellence. The commitment is to create a profitable enterprise with due respect to stakeholders interest, corporate governance and social responsibilities.

Divis Laboratories

Divis Laboratories is a Hyderabad-based pharma company, known for making APIs and intermediates, apart from contract manufacturing. Its activities include custom synthesis of APIs, making building blocks for peptides and nucleotides, carotenoids, chiral ligands etc.

Established in the year 1990, with R&D as its prime fundamental, Divis focused on developing new processes for the production of APIs and intermediates, and in short time, expanded its breadth of operations to provide complete turnkey solutions to the domestic Indian pharma industry.

With five years of experience, expertise and a proven track-record of helping many companies with its turn-key and consulting strengths, Divis established its first manufacturing facility in 1995.

The company's product portfolio consists of two segments—generic APIs and nutraceuticals, and custom synthesis of APIs, intermediates and specialty ingredients for pharma giants. The company has three multi-purpose manufacturing facilities with a total reactor capacity of 4,000 cubic meters and all support infrastructures like utilities, environment management and safety systems. The company's main manufacturing and R&D facilities are located in Andhra Pradesh. Divis Laboratories (USA) Inc and Divi’s Laboratories Europe AG are two of the company's subsidiaries looking after manufacturing and marketing of neutraceutical products in North American and European countries.

Built on a 500 acre site at Hyderabad (Unit-I), the plant comprises of 13 multi-purpose production blocks and has space for further growth and expansion. Divis set up its second manufacturing facility at Visakhapatnam (Unit-II) in the year 2002 on a 350 acre site, which has 14 multi purpose production blocks.

Complete cGMP guidelines are complied within both the plants. Unit-1 at Hyderabad was successfully inspected by the US FDA during September 2000, in April 2004 and in February 2008. Unit-2 at Visakhapatnam was successfully inspected by the US FDA during November 2006. Divis also undertakes FTE/contract research on process development for discovering new compounds for leading MNCs across the world and partners with them for the supply of APIs. The company is global in its outlook and benchmarks its quality standards to the best in the world.

Granules India Limited (GIL)

Granules India Limited (GIL) is a fully integrated manufacturer of pharma formulations best known for making pharma formulation intermediates (PFIs) of acetaminophen/paracetamol, aspirin, ibuprofen, metformin etc. The company also does contract manufacturing of drugs.

Headquartered in Hyderabad, the company has it expertise in manufacturing APIs since 1984 and PFIs since 1993. It has been marketing products in the US since 1987.

The strategic goal of the company is to offer a complete vertical integrated solution. Offering quality products has helped GIL grow, over the years, to become one of the largest manufacturers of paracetamol in the world.

GIL has a long history as a producer of APIs and PFIs with complete vertical integration. It supports customers with unique value, extensive product range and a global network of associates. Its expertise in manufacturing PFIs, which are directly compressible granules, has helped customers to move to the next level of outsourcing in the pharma industry.

The company's PFI plant is one of the biggest in the world with an annual capacity of 7,200 MT and a batch size of 6 MT. The plant is approved by US FDA, German Health Authority, Canadian TPD and Australian TGA. GIL has also commissioned in September 2008 a state-of-the-art tableting facility with a capacity of six billion tablets, which is scalable to 12 billion tablets with minimal investment.

Natco Pharma

The hyderabad-based Natco Pharma has four manufacturing facilities and employs 1,500 people. The company makes branded and generic dosage forms, bulk actives and intermediates. It is also involved in contract research and manufacturing.

Natco manufactures a range of branded and generic dosage forms, bulk actives and intermediates for both Indian, as well as international markets. The products manufactured by the company include Diltiazem, Omeprazole , Lansoprazole, Isosorbides, Sumatriptan succinate, Ondansetron, Sertraline, Granisetron and Paroxetine. The company's products come in various forms, such as timed released capsules, tablets, inhalers, dry syrups, dispersible, syrups and suspensions, ointments, gels, injectables, infusions, sterile preparations and large and small volume parenterals. Natco operates in two business segments—bulk chemicals and finished dosage formulations. The wholly owned subsidiary of the company is NATCO Pharma Inc.

Suven Life Sciences

Suven Life Sciences provides drug discovery and development support services, as well as contract research and manufacturing services to the global life sciences industry. The company is based in Hyderabad. The various products manufactured by Suven are intermediates, advanced intermediates, APIs etc.

Promoted by Venkat Jasti and his wife in 1989, Suven was converted into a public limited company in January 1995.

Suven has world class manufacturing facilities in the business of pharmaceuticals and fine chemical intermediates for global life science companies for New Chemical Entities (NCE's) as the thrust area.

Incorporated in 1989, the company commenced operations in 1990 and expanded into fine chemical intermediates and started exports in1992. The company initiated the Contract Research And Manufacturing Services (CRAMS) business model in1994 and went public in 1995.

In 1999, the company was recognised as an export house and acquired a drug unit at Hyderabad and converted it into a research centre and pilot plant during the same year. In 2001 a new Suven Research Center (SRC) was inaugurated at Hyderabad. During the same year, SRC was recognised as an in-house R&D unit by Department of Scientific and Industrial Research (DSIR), India. In 2002 a cGMP Lab was commissioned at SRC.

The company acquired assets of New Jersey, US- based Synthon Chiragenics Corporation in 2003 and in the same year changed its name to Suven Life Sciences Limited. During the year 2004 the company got ISO 14001:1996 certification for Unit -1 (Suryapet) and Unit-2 (Jeedimetla).

In 2005, Suven was awarded Partner of Choice in Drug Discovery for CNS by Frost & Sullivan. In 2007, Suven entered into a collaboration with University of Minnesota to develop drugs to treat HIV infection. In the same year, the company secured two product patents in Australia and New Zealand for their New Chemical Entities (NCEs) and secured product patents for two more products from European Patent Office (EPO) for the treatment of neurodegenerative diseases.

In 2008 Suven obtained its second product patent from the US Patent Office and established a second CNS drug discovery collaboration with Lilly. It also secured two product patents in all Russian countries (Eurasia Region). In 2009, Suven participated in the Biotech Showcase 2009, and received US FDA acceptance for its first unit. In the same year the company achieved first milestone payment in drug discovery collaboration.

Bharat Biotech International

Bharat Biotech International, Hyderabad, is a multidimensional biotechnology company specialising in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat Biotech, established in 1996 by Dr Krishna M Ella and his wife Suchitra K Ella as the Founder Directors, is engaged in developing next-generation vaccines and bio-therapeutics through innovative and collaborative research.

Bharat Biotech's state-of-the-art manufacturing plant is the largest of its kind in Asia-Pacific. The first bio-pharma facility in the country to be audited and approved by the Korean Food and Drugs Administration (KFDA), it sprawls over a picturesque campus at Genome Valley, Hyderabad. Built with an investment of over Rs 1,000 million, the facility's manufacturing, control procedures and protocols, conform to the stringent standards laid down by international regualtors such as US FDA, UK MCA and WHO.

Bharat Biotech has set new benchmarks in innovation and quality that epitomises the tremendous progress of Indian biotechnology in the global arena.

Shantha Biotechnic

A pioneer in the field of biotech, Shantha Biotechnics is the first Indian company to develop, manufacture and market a recombinant human healthcare product in India. The company is committed to breaking new ground in modern biotech to address critical healthcare needs of the developing world.

The company was taken over by the Merieux Alliance group in November 2006. Merieux Alliance is a France based global organisation having presence in all elements of the healthcare chain: prevention, diagnostics, prognosis, treatment and clinical monitoring

Shantha is currently focusing its R&D efforts in the development of generic biologicals, novel therapeutic antibodies, proteins and vaccines. It conducts exploratory research in the fields of oncology, infectious diseases and platform technologies.

SHANVAC-B is the first Indian Hepatitis-B vaccine to be pre-qualified by WHO, Geneva, for supplying to UN agencies globally. Today, Shantha caters to major international markets including Asia-Pacific, Africa, CIS and Latin America in addition to supra nations like UNICEF and PAHO.

To make cutting edge technologies available to the common man, Shantha is constantly exploring the possibilities of partnerships to facilitate innovations in R&D.

A deep sense of commitment and a tradition of excellence have characterised Shantha’s journey thus far and have placed it in the forefront of exciting scientific ventures. However, there are still bigger oceans to be crossed and farther shores to be reached.

Shantha has also obtained WHO-Geneva pre-qualification for its combination vaccine of DPT+ Hepatitis-B vaccine, SHANTETRA, enabling supplies to UN Agencies.

GVK Biosciences

GVK BIO is a contract research organisation(CRO) and provides contract research services to a rapidly growing base of global pharma and biotech companies. It combines science, innovation and people to help clients address their drug development challenges.

Today, GVK BIO is a part of the $1 billion GVK group. GVK is a diversified enterprise having interests in infrastructure (power, transportation and urban infrastructure), services (hotels, life-sciences and financial) and manufacturing (particle boards, resins and chemicals). GVK BIO is one of India’s premier CROs, providing an integrated platform of research services across the pharma R&D value chain to a growing number of global pharma and biotech companies.

Ocimum Biosolutions

Ocimum Biosolutions is an integrated global genomic services company with operations in Hyderabad, India, and Gaithersburg, Maryland, US. The company provide comprehensive (research level and GLP-compliant) genomic services, reference databases, and LIMS solutions. Its distinct platform “Research as a Service” (RaaS) allows complete outsourcing of genomics--from storing biological samples and performing on demand DNA and RNA based services to validating biomarkers using its proprietary databases and providing data and bioinformatic analysis. Ocimum has been chosen as a global preferred outsourcing provider for more than 75 percent of top 25 pharma and biotech companies plus leading research institutes.

The global infrastructure’s standardised procedures, capacity, and highly skilled staff at Ocimum are capable of supporting drug development programmes from pre-clinical target development and toxicogenomic assessment to clinical biomarker identification and patient stratification. By creating the world’s largest commercial gene expression databases, BioExpress and ToxExpress, the information product offerings and expertise are beyond compare. Ocimum has been consistently ranked as India’s fastest growing biotech company and one of the fastest growing technology companies over the last five years by Deloitte Touche Tohmatsu.

Transgene Biotek

Transgene Biotek was set up in 1991, and was probably the first true biotech company in India. It is listed on the Indian Stock Exchanges and is involved in the development of several cutting edge technologies.

From the knowledge gained in developing recombinant vaccines successfully since 1994, and having gained considerable experience in improving the technology processes of those products, Transgene has expanded its product portfolio to other therapeutic areas such as bio-generics, oncology and New Drug Delivery Systems (NDDS) among others.

Transgene has recently installed an additional four Kl sterile fermentation facility for the commercial production of generic drugs being developed by its own in-house scientists. Transgene is focused on maximising synergies through strategic partnerships.

 



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