Академический Документы
Профессиональный Документы
Культура Документы
Unimark has doubled the headcount of scientists to about 130 in the last 1-2 years to create capabilities to develop 10-15 active pharmaceutical ingredients every year. 1983 : Started as a Marketing Company 1995 : Backward integration with API manufacturing 1997 : Acquired Antibiotic facility at Bavla (Ahmedabad) 2006 : Vapi Manufacturing plant received US FDA approval 2007 : Bavla Manufacturing plant received US FDA approval 2008 : Commissioned a new dedicated facility for Carbapenem. Oncology facility (for high potency compounds) under execution Acquired majority stake in KDL Biotech Ltd
Zen has a vast hand on experience of all Statutory Compliances from DCGI as well as state governments for marketing aspects for Narcotic products. Zen can initiate the process for Clinical Trials and can utilize their network for post marketing surveillance, as they have a good infrastructure support for trials through their contacts with CROs and infrastructure for stability data testing, QA and R&D. The central warehouse of Zen is in Mumbai and it has a distribution network in 20 cities of India including the 4 metro cities. Zen has over 100 products till now.
Product
Zen Lifesciences has over 100 products. One of them is the Amoxicillin Capsules 250. Amoxicillin (INN), formerly amoxycillin (BAN), abbreviated AMOX, is a moderate-spectrum, bacteriolytic, -lactam antibiotic used to treat bacterial infections caused by susceptible microorganisms. It is usually the drug of choice within the class because it is better absorbed, following oral administration, than other -lactam antibiotics. It is also a treatment for cystic acne. Amoxicillin is one of the semi-synthetic penicillins discovered by Beecham scientists. The patent for amoxicillin has expired, thus amoxicillin is marketed under many trade names including: Actimoxi, Alphamox,Amocla, AMK, Amoksibos, Amoxiclav Sandoz, Amoxidal, Amoxil, Amoxin, Amoksiklav, Amoxibiotic, Amoxicilina, ApoAmoxi, Augmentin, Bactox, Betalaktam, Cilamox, Curam, Dedoxil, Dispermox, Duomox, E-Mox (250mg and 500 mg), Enhancin, Gimalxina, Geramox, Hiconcil, Isimoxin, Klavox, Lamoxy, Moxatag, Moxilen, Moxypen, Moxyvit, Nobactam, Novamoxin, Ospamox, Panklav, Pamoxicillin, Panamox, Polymox, Samthongcillin, Clamoxyl, Senox, Sinacilin, Trimox, Tolodina, Wymox, Yucla, Zerrsox and Zimox. Amoxicillin in trihydrate form is available as capsules, chewable and dispersable tablets plus syrup and pediatric suspension for oral use, and as the sodium salt for intravenous administration. It is one of the most common antibiotics prescribed for children, and the liquid forms are helpful where the patient might find it difficult to take tablets or capsules. It has three ionizable groups. A once daily dosing form (Moxatag) was approved by the American FDA in January 2008. Amoxicillin is used to treat many different types of infections caused by bacteria,
such as ear infections, bladder infections, pneumonia, gonorrhea, and E. coli or salmonella infection. In spite of availability of many new generation antibiotics - Amoxicillin is still very popular. Its one of the most common antibiotics prescribed for children. Amoxicillin stands 5th in '2008 Top 200 generic drugs by total prescriptions' as compiled by SDI/Verispan and reported in 'Drug Topics'. Export of amoxicillin has been growing for last 6 years at very healthy rate. However, older antibiotics like Ampicillin are likely to lose market shares to new cephalosporins and quinolones as more people are developing resistance to the older drugs.
Market Segments
Generics occupy 34% of all export sales while branded formulations account for whooping 66%. There are many brands of amoxicillin available in market. There are around 123 different brands of amoxicillin from export shipment records during 2008-09. By dosage form, the market segments identified are: Capsules (77.46%) Syrup + Suspension (8.95%) Tablets (6.11%) Powder + Sachet (4.32%) Injection (1.70%) Dry Syrup (1.19%) Gel (0.27%) By combining above two segment analyses, one may conclude that branded capsules is the largest market segment.
Largest Markets
10 countries account for 49% export of Amoxicillin. South Africa, Nigeria, Myanmar, SriLanka and Netherlands are top 5 export markets of Amoxicillin, as per analysis of shipment records collected from 18 major seaports, airports and dryports.
South Africa emerges as the largest market, accounting for 11.19% market share (2008-09) by value. Nigeria, Myanmar and Sri Lanka follow in quick succession. Africa and Middle East are the largest regional markets.
Direction of Trade
The major exports of Zen Lifesciences Amoxicillin is in Angola, an African country. Being a company which is in its initial stages of development and expansion Angola is a very good market for the company as there are no registrations required to export in the country. Apart from Angola Zen Lifesciences export Amoxicillin in Semi- regulated markets like the African countries, South Asian and Asian countries and CIS countries. It is looking forward to export its products in regulated Markets like the U.S, European Countries, Japan, etc.
conditions of supplying the goods and services and in particular the price allowed to be charged. It aims at exporting their products in such regulated markets in the next few years to come.
Export Prizing
Domestically, the average price of Amoxicillin Capsules 250 is Rs. 4 per Capsules. A through market research is done in the country which the company is looking forward to export. After all the expenditures are calculated, a profit of 5-10% is kept. Since Amoxicillin is a generic drug, there is a lot of competition in the market. To make healthy profits by exports it is necessary to go with the existing price. Even if the expenditures are high it is nearly impossible to increase the price of the drug. Hence pricing of Amoxicillin capsules is totally dependent on the market. If the existing price is lower than the expected profit, the company does not export in that country as they do not achieve their targeted profit. It is easier to export the products in the semi-regulated markets as the registration procedure and expenditure is less expensive. It helps the company to make more of profits. Regulated markets like US and UK demand for stricter procedures which inadvertently increases the expenditures and getting lesser profits.
The 'Common Technical Document' or 'CTD' is a set of specification for application dossier for the registration of Medicines and designed to be used across Europe, Japan and the United States. It was developed by the European Medicines Agency (EMEA, Europe), the Food and Drug Administration (FDA, USA) and the Ministry of Health, Labour and Welfare (Japan). The CTD is maintained by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Common Technical Document is divided into 5 Modules : 1. 2. 3. 4. 5. Administrative and prescribing information Overview and summary of modules 3 to 5 Quality (pharmaceutical documentation) Safety (toxicology studies) Efficacy (clinical studies)
Detailed subheadings for each Module are specified for all jurisdictions. The contents of Module 1 and certain subheadings of other Modules will differ, based on national requirements. After USA, European Union and Japan, the CTD has been adopted by several other countries including Canada and Switzerland. The Paper CTD is destined to be replaced by its electronic counterpart, the eCTD. The Techpack dossier is the second type of dossier. The Techpack dossier does not have a lot of specifications unlike the CTD dossier. It is less expensive and less time consuming than the CTD dossier. Apart from submitting the dossiers some countries also require factory inspection. If the production factory meets the standards of the country, then the company gets the approval to export their product in that country. There are also timelines for registration. Depending on the countries the timelines vary. Some country takes 6months to approve the registration, while some take 2years to approve. After the application is submitted for registration, the dossier given and the factory inspected, the country then gives the approval for exporting in their country. Export can be conducted in two ways. First by setting up a branch of the company in the country and second by having a representative in the country.
Zen Lifesciences do not have their own branch in other countries. They have representatives in those countries, who on their behalf deal with the government, submit the necessary documents, conduct market research and market their product. Since Zen Lifesciences is in its developing stage, it is very convenient for them to have representatives in other countries. The representatives in Angola carry out marketing procedures, whereas the representatives in the South Asian countries are carrying out the documentation procedures.
Export Incentives
The government of different countries gives incentives to exporters in the form of tenders. Tenders are offers given by the government to sell the drug at a minimum expense. But the companies make profit if they get the tender as their drug is sold in all the government facilities. And all the doctors in the government hospitals prescribe this drug to their patients. Various companies submit their tenders and the company with the minimum cost gets the tender. If the company gets the tender it gets benefit schemes till the tender expires. The company does not have to worry about profits as the profits are secured by the government of the country.
Effect of Recession
The Company has not suffered any effects of the global slowdown as they sell basic necessary drugs. The demand for these drugs have not declined due to which they have not experienced a major impact. Their major drug that they export are cancer drugs which is a life saving necessary drug.
And hence they claim to not have been affected by the recent global slowdown.
Future Vision
The future vision of Zen Lifesciences is to achieve revenue of US $ 1bn by 2020 and to contribute towards making healthcare affordable The company intends to open 14-16 facilities to offer radiation, chemotherapy and oncology-specialised pharmacies under one roof across the country within a year as comprehensive cancer care hospitals are rare in the country To be a global Life sciences company through innovation, cost leadership, optimizing economic value creation for share holders To create and sustain value with a deeply embedded corporate culture of Commitment, Core Value, Integrity and Continuous search for excellence. To be sought after as best employer and well respected by the business community and by their competitors. A responsible corporate citizen respecting environmental and regulatory compliances