Dr Reddy's Laboratories Ltd
Dr Reddy's has come a long way from being a mere exporter of bulk drugs to cost effective provider of drug discovery research. The company has out-licensed three molecules so far. The company's main focus is in diabetes, cardiovascular, anti-infectives, cancer and inflammation. Today, Dr Reddy's has presence in more than 50 countries with USA, UK, Russia and China as its main markets.
The company is planning to launch two new products, ciprofloxacin and isotretinoin during the current year. The company has a target of 15 ANDAs and DMFs for the current year. Currently the company has 24 ANDAs and 43 DMFs pending with US FDA. During the next year the company targets 4-6 new launches.
The company is trying to enter US specialty business segment with its own branded finished dosage forms. The company had filed NDA with the US FDA for amlodipine maleate, another version of Pfizer's Norvasc. However, this is facing litigation in US courts.
The company has undertaken drug discovery research to meet the challenges of post 2005 era. Dr Reddy`s has seven new chemical entities in the pipeline, of which four are in the pre-clinical stage and three are in the clinical study stage.
Though the company's growth in domestic market is expected to be above the industry growth, major push for its sales is expected from exports sales. Russia and CIS countries will be the major growth drivers for the company. The company bulk drugs exports is also expected to perform well.
The company is targeting a sales turnover of Rs 1,800 crore for the year 2003-04 and the first quarter results of the company suggest that the company is well on course to meet its target.
Ranbaxy Laboratories Ltd
Ranbaxy is the largest pharmaceutical company in the country. The company has presence in anti-infectives, nutritional, gastro-intestinal, non-steroidal anti-inflammatory systems, dermatology, orthopedics, CNS and cardiovascular. In cardiovascular the company recently introduced Rosuvastatin in the country recently. Apart from this the company is also active in animal health, diagnostics and specialty chemicals.
Most of the turnover of the company comes from domestic market and USA contributing insignificant portion of the sales. Middle East, Europe, CIS and Africa constitute other major markets of the company.
Recently the company signed an agreement with Anna University wherein the latter will screen compounds from natural as well as synthetic sources for activity in areas of metabolic disorders, urology, inflammatory and respiratory disease. Based on these studies, Ranbaxy will optimize leads, identify candidates for development and conduct pre-clinical development.
The company is setting up an R&D Centre in the Shapoorji Pallonji bio-tech park in Andhra Pradesh. The company will be investing Rs 120 crore on this center which will be spread over an area of 100 acres of land.
Ranbaxy recently received tentative approval from USFDA to manufacture and market Simvastatin Tablets. The company has also received an approval from the US FDA to market Panixine Disperdose. Ranbaxy Laboratories has also got an approval from USFDA for the oral version of Riomet, an anti-diabetic drug used for the cure of Type 2 diabetes.
Recently the company received a notice from NPPA for Rs 25.4 crore being the 50% of the amount allegedly overcharged in respect of the three products pending adjudication by the Mumbai high court.
During the first quarter of the current year the company posted net profit of Rs 280 crore which is more than the net profit of whole of 2001 and 45% of the net profit of 2002. During the first half of current year the company recorded Rs 477 crore of net profit which is more than three fourth of last year's net profit. Surge in net profit is mainly due o improved margins of the company.
Lupin Ltd
Lupin Ltd was formed after amalgamating Lupin Laboratories Limited and Lupin Chemicals Limited. The company is a leading manufactuirer of Rifampicin, Pyrazinamide, Ethambutol (anti-TB), Cephalosporins (anti- infectives) and cardiovasculars. The company is the world's largest producer of anti-TB drugs and enjoys more than 40% of domestic market share. It is one of the leading global manufacturers of Rifampicin (through the complex fermentation process) with a domestic market share of 45 per cent. In Indian pharmaceutical industry, Lupin has among the the largest number of plants approved by US FDA. The company's Rifampicin plant is one of only three plants in the world to receive a US FDA certification. Also the company's one of the plants is approved by UK MCA.
Till date Lupin has filed 110 patents, of which 50 have been granted. During the second quarter of 2003-4 the company received approval for three ANDA and hopes to get two more ANDA application approval during the third quarter of the fiscal 2003-04. The company plans to file 10-12 ANDA in the fiscal 2004-05.
The company will be increasingly focusing on North America and Europe for growth. The company also has significance presence in China and is also making inroads into CIS countries.
Though the company's operating margin has improved during the first half of the current year, interest burden is taking its toll on bottom line. Despite settling some of the debts, at the end of last year the company had a huge debt burden of 587 crore.
Among the positives, the company's export performance is improving year after year. During 2002-03 exports contributed nearly 37% of the turnover and the company targets to exports 50% of its turnover by 2005.
Sun Pharmaceutical Industries Ltd
In the Indian prescription market Sun Pharmaceutical, a speciality pharma company, enjoys 5th rank. Psychiatry, neurology, cardiology, diabetology and gastroenterology account for 72% of company's domestic formulations sales. Exports account for 17.1% of the total turnover of the company.
Sun Pharmaceutical plans to have two novel drug delivery system (NDDS) in human clinical study by next year and one new chemical entity (NCE) in human clinical study by 2005.
The company is setting up a 9500 sq.ft. built up area formulation site at Jammu which will comply with USFDA and UK MCA. The facility will become operational during the next year. Another manufacturing unit at Dadra being set up with a built up area of 12,500 sq.ft area. Both these units have been formed as partnership firms between Sun Pharmaceutical and its employees. Both these units will add 1560 million tablets/year manufacturing capacity to the company.
The company's US subsidiary, Caraco Pharm Lab received 6 ANDA approvals during 2002 and one more during the first quarter of 2003. Three more ANDAs are awaiting approval with US FDA. For the first half of Caraco notched up a turnover of $20 million with net profit of $6.5 million. However, the company has a debt burden of $31 million and whatever cash flow this will generate in the coming years will go to retire these debts.
During 2002-03 the company has achieved a turnover growth of 15% and the exports grew by 40%. In the coming years the company plans to give greater thrust to exports so as to achieve export: domestic sales ratio of 30:70. The company will focus on 30 key products in formulation export.
Cipla Ltd
A leading pharmaceutical company, Cipla has presence in antibiotics, anti-bacterials, anti-asthmatics, anthelmintics, anti-ulcerants, oncology, corticosteroids, nutritional supplements and cardiovascular drugs. The company is one of the lowest cost manufacturers of anti-HIV drugs in the world. Nearly 85% of the company sales come from formulations.
Exports contribute nearly 35% of the total turnover. The company has filed 11 new drug applications in USA. The company is planning to file few more applications during the year. The company has also 185 applications for bulk drugs in various parts of Europe. Though its earlier plan to launch CFC-free inhalers in Germany has failed to take off, the company is currently working on nine non-CFC inhalers. The company also has plans to carry the clinical study in Europe and India. Cipla is also working on 20 dry powder inhalers, which would also need clinical study. Recently the company was in news for wrong reasons. The company hadrecently received demand notices from the national pharmaceutical pricing authority (NPPA) requiring the company to deposit Rs 103.61 crore, 50 per cent of the claim raised by NPPA for the period up to June 2000.
The company expects exports growth of 40% during the current year. The company aims achieve sale turnover of Rs 1,700 crore during the year. Looking at its performance during the first quarter the company seems to be well on its course to achieve this target. However, appreciating rupee may spoil the party. Further, declining operating margin is another matter of concern for the company. The company has lined up a capex plan under which it will be spending Rs 60 crore on modernization and expansion of facilities at its Goa plant.
Orchid Chemicals & Pharmaceuticals Ltd
Orchid is one of the largest cephalosporin bulk active ingredients in the world. The company specialises in the manufacture of both oral and sterile cephalosporins. By acquiring Mano Pharmaceuticals in January 2003, the company has made a strategic entry into specialty formulations. With this the company has been able to build up large basket of formulations comprising 30 products from Orchid Healthcare and 60 products from Mano Pharmaceuticals.
During 2002-03 the company was able to secure USFDA certification for its cephalexin product. During 2002-2003, the company also commissioned new USFDA compliant oral and sterile cephalosporin bulk actives facilities earmarked for the regulated markets. Recently its bulk drug manufacturing facilities located at Alathur, near Chennai, have been successfully inspected by the European Directorate for Quality of Medicines (EDQM) and Medicines and Healthcare Products Regulatory Agency, UK. The company is working on a programme to file ANDA for new formulations from its new manufacturing facility at Irungattukotai. The company is also working on a project to develop product for animal health applications on a contract research cum commercial supply arrangement basis.
The company whose turnover from regulated markets is around 110 crore aims to double this figure during 2003-04. Presently the company is mostly concentrating on non-regulated markets for its exports and hence its margins are low. The company has launched six new products with help of which it aims to achieve sales growth of 40% during the year.
During 2002-03 the company's topline grew by just 27%. However, the company was able to triple its bottom line. During the first quarter of the current year, though the company's margin came under little pressure better top line growth has ensured respectable bottom line. With all its infrastructure facilities in place, the company has now set itself to enter into phase of higher growth.
Nicholas Piramal India Ltd
Though the company is ranked four in domestic market, it is not a major player in the international market with exports contributing less than 4% of its turnover. Now the company is also trying to gain foothold in exports. The company is exploring the opportunities of being a reliable partner to some of the multinational companies for manufacturing bulk actives and intermediates. The company is also weighing the option of collaborative research pacts with multinational pharma companies in a host of therapeutic areas.
In recent times the company major growth came inorganic route. Recently the company acquired Rhone Poulenc and ICI's pharma division engaged mainly in the cardiovascular products. Now the company is reportedly is in race to acquire French-based generic company RPG Aventis, in an attempt to gain a foothold in Europe.
The company has been able to reduce its debt burden substantially due to repayment of debts and also swapping of high cost debts with lower cost ones. As a result the company was able to cut down its interest cost by 34% during 2002-03. During the year 2002-03 the company's formulations sales grew by 20% while sale of vitamins and fine chemicals grew by 35%.
In the domestic market, the company is targeting a four to five per cent growth above the growth of the domestic pharmaceutical industry. Most of the growth is expected to come from old molecules. The company also plans to launch high potential new molecules.
Wockhardt Ltd
Wockhardt which spends 6% of its turnover on R&D has developed leading brands in Anti-infectives, Pain & Inflammation, Cough, Psychiatry, Medical nutrition and Biotechnology segments. Exports account for 38% of the company's turnover and it is growing at the rate of 41%. Formulations exports which constitute 43% of the total exports have grown by 90% during 2002. The company has targeted Rs 400 crore exports turnover in next two years.
The company's R&D has developed India's first fluoroquinolone anti-bacterial for tropical use. The product has been well received by the medical fraternity. The company's drug discovery is focused on anti-infectives. The company recently received USFDA approval for marketing bethanechol chloride tablets in the US. Wockhardt`s product will be the only generic alternative to Urecholine of Odyssey Pharmaceuticals.
The company's biotechnology products, Hepatitis-B and Erithropoietin have well received in the domestic market. The company is building global manufacturing capacity for recombinant human insulin. Biotechnology products expected to start contributing to the company`s export turnover from fiscalyear 2005.'Registration activities for Wepox and Biovac B in several markets are in full swing. The company expects to launch a series of biotechnology products in North America and the European Union in the coming years. Some of the biotechnology products in the company's product pipeline are Interferon, alpha-2B, G-CSF, monoclonal antibodies, quadrivalent vaccines, etc.
Company's first half performance was affected by its poor numbers in first quarter. During the first quarter the company's net profit fell by 65% as compared to the same period in the previous year.
IPCA Laboratories Limited
Ipca Laboratories is engaged in the manufacture of pharmaceutical products such as tablets, capsules, vials and ampoules. The company has leadership position in anti-malaria products in the country. The company is laying greater stress on formulations business as a result of which its formulations account for 68% of its turnover. Now the company's products are exported to 90 countries all over the world. Recently the company has set up a wholly owned subsidiary in Brazil to tap the potential in Brazil and Latin American countries.
Growth is bulk drugs and drug intermediaries business is slowing down and last year it gew by just 9%. Nearly 80% of the sales of this division are from exports and the company exports directly to end users.
Over the years share of domestic sales in the total income is decreasing while that of exports is increasing. In 1993-94 exports accounted for just 36% of its turnover but this percentage has gone up to 57% in 2002-03. Increased focus on formulations both in domestic and exports market and change is product composition has helped the company to increase its bottom line exponentially over the years. In fact its net profit has gone up by six times during the last ten years while its sales have increased only 3.5 times. Between 2001-02 and 2002-03 its net profit has almost doubled.
Cadila Healthcare Limited
With the merger of German Remedies and Recon Helathcare, Cadila Helthcare has catapulted to 4th rank in Indian pharmaceutical industry with a market share of 3.8%. Cardiovascular, gastrointestinal, women's healthcare and respiratory are the main segments the company is catering to. Of late the company is mainly concentrating on inorganic growth through acquisitions and mergers. The company is planning to take over Alphrma SAS, a French company prominent in generic drugs.
Cadila Healthcare has also bagged the global marketing rights of Vaxirab, an anti-rabies vaccine, from Swiss company Berna Biotech. Fermenta Biotech Ltd (FBL), a subsidiary of Duphar Interfran Ltd, has recently signed an agreement with Cadila Healthcare Ltd for sale of FBL`s global patents of Chiral building blocks and process technology for the manufacture of Lisinopril & Benazepril. Under this agreement, Cadila has obtained the exclusive rights for commercialization of this technology, with manufacturing assistance being provided by FBL.
The company is making concerted attempt to foray into USA market. So far the company has filed 9 DMFs of which three have been approved. The company is also aiming to file an ANDA during the current year. Also the company has identified France, Italy, Spain and Germany as the major markets for its products in Europe. Brazil is another destination where the company is eyeing for its growth.
Though the company's sales has grown by 60% during 2002-3, growth in bottom line is less than 15% which is mainly due to burgeoning interest cost. Interest expenditure has taken a quantum jump from Rs 8 crore in 2002-02 to Rs 38.8 crore in 2002-03 which is a matter of concern. However, the company has an ambitious target of doubling the sales and tripling the profits by the end of next three years.