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TORRENT PHARMACEUTICALS

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TORRENT PHARMACEUTICAL S

TORRENT PHARMATorrent Pharmaceuticals is a flagship company located at Ahmedabad (India). It produces Bulk drugs and compounds in the therapeutic areas of cardiovascular and central nervous system. Torrent Pharma has also entered areas like gastro-intestinal, diabetology, anti-infective and pain management systems. Torrent Pharmaceuticals was set up in the year 1959 and was initially headquartered in Ahmedabad (India). Torrent Pharmaceuticals was derived from the name Trinity Laboratories Ltd. which was promoted by U. N. Mehta and now trades in 50 countries with more than 1000 product registration across the globe. Torrent Pharma has drawn a revenue of 13.3 billion for the year 2007 and its net income for the same is 0.9 billion. TORRENTPH is a flagship company which manufactures Bulk drugs and compounds in the therapeutic areas with main concentration on cardiovascular and central nervous system. Torrent Pharmaceuticals Limited has six divisions for marketing and each division succumbs to the defined therapeutic areas. Torrent Pharma has established 22 new conceptualizations in the Indian market and 14 for the international market that includes Europe, Russia and Brazil. TORRENTPH has also launched a subordinate in Brazil and has stretched its focus on Russia and CIS countries during 2004-2005. Five fully owned subordinates of Torrent Pharmaceuticals are:

Torrent do Brasila Brazil Torrent Pharma Gmbh Germany Torrent Pharma Ltd. Philippines Zao Torrent Russia Torrent Pharma Inc USA

Torrent Pharmaceuticals Limited also started to export Lamotrigine to the EU market. Torrent Gujarat Biotech, the sister concern of Torrent Pharma, was established in 1992 in order to manufacture Penicillin through fermentation technology developed by the Torrent Group. TORRENTPH bears the R&D expense of Rs.673.2 million (14.3% of the turn over). With regard to that, Torrent Pharma has launched a R&D center that deals with new chemical entities for vascular complications and metabolic disorders. Torrent Pharmaceuticals has also undertaken a project in partnership with AsiaZeneca. The company is also engaged in DPCO (drug price control orders practiced on 24 drugs at present) which is run under three level of

regulations which are: on Bulk drugs; on formulations; and on total profitability.

PRODUCTSHighlights :

Leaders in Cardiovascular and Central Nervous System areas. Significant presence in Gastrointestinal, Anti-Infective, Anti-diabetics and pain management segments.

Products manufactured include :

TABLETS CAPSULE PARENTERAL

List of APIs Manufactured :

Nicorandil Risperidone Venlafaxine Hydrochloride Ropinarole Hydrochloride Duloxetine Hydrochloride Ormeloxifen Hydrochloride Nebivolol Hydrochloride Lamotrigine Sertraline Hydrochloride Clopidogrel bisulphate

MANUFACTURING: INDRAD PLANTTorrents manufacturing facility at Indrad, Gujarat, was set up in 1989. Today, the Indrad facility is at par with international standards. It complies with WHO, cGMP, MHRA and TGA norms and has received ISO 9001, ISO 14001 and OHSAS 18001 (Occupational Health and Safety Management System) certifications; adequately reflecting Torrents commitment towards quality and safety. Attainment of such standards have also opened the key to gaining footholds in regulated, lucrative markets like the US and EU for Torrent Pharma. Infrastructure ::

Land - 178,000 sq. metres Built-up Area - 50,000 sq. metres for Formulations, 10,000 sq. meters for API Excellent Support Services Finished Products - Oral Dosage Form, Injectables, Freeze Dried Sterile Injections API - Multi Product, Versatile Facility, Upgraded to International Standards Hygiene Zones Process step dependent special zones created for each type of activity

Manufacturing Capacities (per annum) :: Formulations - Tablets, capsules and vials Bulk Drugs/API 6,000 million 15,000 kg

BADDI PLANTBaddi Plant :: Set up with an investment of over Rs. 130 crores, the Baddi Plant is a most modern, state-of-the-art facility that will cater to the requirements of domestic markets. The Plant commenced operations in November 2005 and has a capacity to manufacture 3600 million tablets, 400 million capsules and 18 million Oral Liquid bottles, per annum. Other operations at the Plant have been streamlined, with the critical machines and operations already functional at the Plant. Production of most of the domestic products has already been shifted to Baddi. Infrastructure :

Land 82, 237 sq. metres Built-up Area 23, 000 sq. metres Finished Products: - Oral Dosage Forms (Main Plant): Tablets, Capsules, Liquids, - Oral Dosage Forms (Cephalosporins Plant under construction): Tablets, Capsules, Dry Powder Suspension, Insta use liquids. Hygiene Zones - 'O' Open Product Area, 'E' Closed Product Area, 'F' Non Production Area

Impact of a new product on overall growth

Effectiveness of New Product Launch of different companies

QUALITYTorrent's quality policy is mandated and supported by the Executive Management and coordinated by an independent Corporate Quality Assurance (CQA) Department. Highlights ::

First Indian pharmaceutical plant to get ISO 9001, ISO 14001 & OHSAS 18001certification. Quality Assurance is independence of Manufacturing. In-Process quality is checked during manufacturing. Validation of facilities, equipments, process, products & cleaning as per Master Plan. Complaint Handling. Storage of quality record and control samples. Stability Studies. Registration Documents (DMF)

Quality Assurance Department handles the following activities :: Technology Transfer :

Receipt of product design documents from Torrent Research Centre (TRC). Distribution of documents received from TRC. Checking & approval of documents generated based on TRC documents i.e. Batch Manufacturing Record. Scale-up and validation of product

Validation :

Preparation of validation plans for facility / equipments / process including cleaning. Approval of protocols for validation of facility / equipment / product / process. Team member for execution of validation of facility / equipment / product / process.

Documentation Control :

Controlled distribution and archiving of documents. Control of changes made by proper change control procedure.

Approval of all documents

Assuring Quality of Products :

cGMP training SOP compliance Audit of facility for compliance Line clearance In-process counter checks Critical sampling Record verification Release of batch for marketing Investigation of market complaints Stability of products

QUALITY CONTROL

The QC department performs following activities:

RM/PM analysis (Flowchart) Finished Products analysis (Flowchart) In-process Checks (Flowchart) Stability Studies

The QC activities are managed through four sections:

Instrumental Analysis and Finished Products Wet Analysis Laboratory Microbiological Testing Laboratory Packaging Material -Testing Laboratory

Quality Control for API / PM, Finished Products & In-Process Control is as follows : Flow Chart - RM / PM Inspection ::

Flow Chart - Finished Products Inspections ::

Flow Chart - Inprocess Checks ::

SERVICES OFFERED1) Tablet Facility ::

Tablet facility: Modernized / Upgraded to Meet International Standards. Department has following Hygiene Zones: o 'O' Area - Products exposed to environment o 'E' Area - Products in close containers o Entry from 'E' to 'O' area is restricted by separate gowning procedure. Area-wise personnel and material movement through separate air lock. All manufacturing area has 100% fresh air to avoid cross contamination.

2) Capsule Facility ::

ENCAPSULATION Hard Gelatin o Pellet Filling o Tablet Filling o Combination of Powder/Pellet & Powder / Tablet Filling Soft Gelatin

3) Parentals Facility :: Facility has been designed under technical guidance of M/s. Novo Nordisk, Denmark which complies International Regulations.

VIAL : INSULIN AMPOULE FREEZE DRYING AREA GREEN : BLUE RED CLASS 10,000 & CLASS 100 UNDER LAF : CLASS 1,00,000 CONTROLLED : ENVIRONMENT

4) Packaging Facility ::

Aluminium - PVC / PVDC (Blister) Aluminium - Aluminium Foil (Strips) Aluminium - Aluminium (Cold forming) Bulk Packaging Pouch Packaging (triple laminated foil) Vials / Bottle Packging

Area Design ::

Primary Packaging ('O' Area) - 100% Exhaust Each machine in closed cubicle Connected to Dust Extraction System Controlled environment (low RH - selective) Secondary Packaging ('E' Area) Segregation of each packaging line Stringent checks and controls at final packaging.

5) Active Pharmaceutical Ingredients Plant Facility :: API production plant is divided in two part, Technical plant and Pharma area. Technical plant is provided with once through filtered air while Pharma area is provided with once through filtered air-conditioned air. 6) Supply Chain Management Facility :: Supply Chain Management activities at the manufacturing plant mainly include: Production Planning / Inventory Control / Warehousing / Information

Technology. It coordinates with the Procurement Division for timely availability of inputs and with Marketing Department to make all products available timely, as per the requirements, and distribution of products to C & F Agents all over the country, and of finished goods to Cargo Handling Agents for exports. Production Planning and Control :: It is one of the core functions of all the manufacturing activities Activities include

Production Planning Indent of raw material and packaging material. Inventory monitoring to meet with marketing requirements

7) Engineering Services Facility :: The department works as a support function for the entire plant activity, including new project, formulation and API production, administration, estate upkeep, environmental controls and ensures compliance of all statutory as well as regulatory directives. This calls for multi disciplinarily technical expertise and constant knowledge update to keep pace with changing trends in the industry. Quality Control Facility :: Major Instruments ::

TOC Analyzer Gas Liquid Chromatograph with Head Space with Auto Sampler attachment to estimate very trace level (ppm) of organic volatile /toxic solvents to meet ICH guidelines Total Organic Carbon analyzer with SSM for Cleaning Validation of manufacturing equipment to ensure that product is practically free (ppb level) from previous product. Ultra Pure Water Purification system for HPLC grade water (TOC< 10 ppb and particles < 0.22 micron, Endotoxin < 0.001 cfu/ml.) Video Microscope for monitoring the crystallinity of Insulin products. Fourier Transform Infra Red Spectrophotometer to ensure total identity/ genuineness of the product. Slit to Agar to monitor Viable Count / Area monitoring to ensure that the Production, QC and Stores areas are meeting international standards. Steri Test, a closed concept membrane filtration system for sterility testing to reduce the rate of false positive results. Automatic Glass Ware Washing and Drying Machine to ensure right quality of cleanliness of the glass wares. High Performance Liquid Chromatographs

DOMESTIC OPERATIONSTorrent has to its credit, leading brands in various therapeutic segments. It is a dominant player in the therapeutic areas of Cardiovascular (CV), Central Nervous System (CNS), Gastro-Intestinal, Diabetology, Anti-infectives and Pain Management. Efforts are on to increase its salience in other therapeutic areas as well. In the domestic market, the focus is exclusively on ethical allopathic market and the higher end of the institutional market in urban and semi-urban areas. To sharpen its focus and enhance its customer reach in the domestic market, Torrent operates through sales and marketing divisions structured on specific Therapeutic areas. Currently, it has 11 sales and marketing divisions- Vista, Prima, Delta, Psycan, Azuca, Mind, Axon, Neuron, Omega, Sensa and Alfa, each of which have a clear therapeutic focus.Torrent Pharma promotes various platforms for knowledge sharing including conferences for doctors. It continues its efforts towards customer education on various diseases and their symptoms and cures, thereby increasing customer awareness. In-licensing deal withTasly Torrent Pharma recently entered into an agreement with Tasly, one of Chinas largest pharma companies, to exclusively market their blockbuster drug, Cardio-tonic pill, in India.

INTERNATIONAL OPERATIONSTo enable strategic differentiation, Torrent Pharmas international business is segregated into five different zones: United States of America Latin America Russia & CIS Europe Rest of the World Japan

MARKETING DIVISIONSPrima :: Prima, the second largest division of Torrent Pharmaceuticals Ltd, offers a range of products mainly in the therapeutic areas of gastrointestinal, pain management and anti-infectives, catering to common ailments Vista :: Vista, the largest division of Torrent Pharmaceuticals Ltd, offers a range of products mainly in the therapeutic areas of gastrointestinal, pain management and anti-infective, catering to common ailments. This division is a primary contributor to the domestic sales of Torrent Pharmaceuticals Ltd. Omega :: Omega, the new cardio-diabeta (C&D) division of Torrent Pharma, exclusively focuses on the Cardio-metabolic diseases, with special focus on diabetes and nephrology. Torrent, with sales of Rs. 180 crores, currently has a 4.8% share in the Rs. 3750 crore C&D market. Omega will complement Torrents existing

C&D divisions, Azuca, Delta and Psycan and will help the company increase its market share considerably. Psycan :: Psycan is a super specialty division focusing on therapeutic areas of Cardiology and Critical Care. Delta :: The newly formed Delta division provides drugs for the lifestyle diseases and operates in Cardiology and Diabetology therapeutic segments. This division is a leading player in Hypertension management and Diabetology segment in the domestic pharmaceuticals market. Azuca :: Psycan AzuCa spearheads Torrents strategy of sharpening focus on one of the fastest growing disorders, Diabetes Mellitus. It provides comprehensive metabolic care and caters to therapeutic areas like diabetes and associated complications, Dyslipidemia and hypertension. Mind :: Torrent is acknowledged to be the pioneer of mental healthcare in India. Mind is operational in the super specialty therapeutic segments Neuron:: Torrent Pharma started off with products in the therapeutic segment of neuropsychiatry. During all the years following its inception, it has been striving to bring the best therapy available for Neuropsychiatric disorders. In its endeavor to achieve this, a need to give individual focus to the neurology and psychiatry segments was felt. This gave shape to a new division of Torrent Pharma- Neuron, focusing exclusively on Neurology. Some of the brands, earlier under Mind division but catering to neurology, have now been brought under Neuron. Neuron would mainly cater to Antiepileptic, Anti-parkinsons, Alzheimer, Neurotonics and Anti-depressant segments. Axon :: Axon was established to gain advantage in terms of better focus on existing brands, improved capability to handle new introductions, thereby addressing portfolio gaps and maintain frequent customer contact.

Axon shares antipsychotic, antidepressant and anti-epileptic baskets, the top 3 therapeutic segments of CNS market, with Mind and Neuron.

Sensa :: The new CNS division, Sensa, focuses exclusively on the ailments inflicting the geriatric population. This includes Parkinsons, Alzheimerss and depression that are some of the most prevalent ailments in this segment. Alfa :: The third new division, Alfa is in the mass products segment and focuses on Gastro, Ortho, and Anti Infectives segments. The gastro-intestinal market is worth around Rs. 3000 crores and is growing at 19%.

Customer perspectiveTorrent has at all times provided dependable products for its customers, as a good reputation is a brand in itself. Torrent donated Rs. 1 crore to the Prime Ministers National Relief Fund to rebuild the lives of Tsunami victims. Realizing the need for specialized hospitals, Torrent has established and manages medical institutions Torrent's other significant contributions include establishment and financial support to dispensaries, health foundations, community centers and hostels for meritorious students.

Operational successTorrent Pharmaceuticals Limited is a major player in the Indian pharmaceuticals sector with the vision of becoming a global entity. Torrent Pharma enjoys dominance in the niche cardiovascular and central nervous system, management and oral anti-diabetic segments. therapeutic areas like, gastro-intestinal, pain

It is among the largest spenders on R&D and has set up one of the most advanced research centers in the country at an investment of Rs. 200 crores so far Manufacturing facilities have received quality certifications from various international regulatory authorities.

FAILURES

Absence of marketing audit Marketing arrogance Lack of pace in marketing Lack of product introductions Lack of innovation on a continuous basis Change of competent heads Rising cost with low productivity Faulty distribution network

RECOMMENDATIONS

It should focus more on new products. It should improve the marketing tools used to introduce product. Professionalism is important. Avoid regular change of competent head.

BIBLIOGRAPHY1)

www.torrentpharma.com

2) En.wikipedia.org/wiki/Torrent_Pharmaceutica ls

3) Business.mapsofindia.com