With an investment of US$50 million, Salalah-based Zynova (OPPC) is going global with hormonal & generic drugs, tech-transfers & joint ventures, plus registration services back-up for any and every country
The pharmaceutical market in the Gulf region is on a fast track, growing at 10 per cent per year (almost twice that of the global market) and with an annual turnover of US$4 billion plus. Saudi Arabia and United Arab Emirates alone account for about 85 per cent of the total pharmaceutical sales in the Gulf Cooperation Council (GCC) countries. For many years a strong public market characterised the markets in the Gulf region, with the governments being the main purchasers of drugs through tenders.
However, in recent years, the importance of the private market has increased dramatically. For two reasons: First, a large proportion of the expatriate labour force in many of the GCC countries are excluded from state health care. Second, those seeking treatment abroad in Europe or in the US are now seeking treatment in the region at high-class private clinics and hospitals operated by expatriate doctors and surgeons with high qualifications from Europe or the US.
Quite a few of these clinics and hospitals have opened their doors lately, and are attracting patients even from the Western countries for specific treatments. Another strong reason is the move away from common disease pharmaceuticals, such as antibiotics and vitamins, to medicines for diabetes, cardiovascular diseases and oncology.
Oman Pharmaceutical Products Co. LLC Zynova (OPPC) is one such entity which is taking advantage of this golden opportunity. OPPC's ultra modern plant is a business unit of Al Bahja Holdings in Muscat, chaired by Ajit K Hamlai, an Omani national. Located at Raysut Industrial Estate, Salalah, the plant is at par with the best in the world.
The fully integrated manufacturing facility offers a broad basket of popular products, strong product development capabilities and all encompassing emphasis on total quality management. The design concept for the facility incorporates the latest technology in terms of layout, flow of men and material, heat ventilation and air conditioning (HVAC) systems and the treatment of water. The facility complies with all international regulatory guidelines and the comprehensive General Manufacturing Practices (cGMP) certification.
This facility is capable of producing oral solids (tablets, capsules, dry powder for oral suspension), oral liquids (suspensions, syrups and elixirs) as well as ointments, creams and gels. A unique feature of this plant the only one of its kind in the Gulf region is the dedicated area for manufacturing hormones.
Apart from developing and manufacturing generic and over the counter (OTC) medicines, the pharmaceutical facility also offers contractual manufacturing services to multinational corporations and large pharmaceutical organisations wanting to outsource their production. Such alliances are part of OPPC's strategy to supplement its expertise through partnerships, co-promotions and licensing agreements.
German accreditation
Oman Pharmaceutical Products Co. LLC is accredited to the Government of Upper Bavarian Authorities, Germany as well as to the Ministry of Health, Oman and the GCC Central Committee for Drug Registration.
"The German accreditation allows us to export to the European Union, because of the Mutual Recognition Treaty among the European Union. We have successfully cleared their audit in January this year, and received the certificate," says General Manager Rajendra H Bhandari.
With an investment of US$50 million, the 32,800 square metre pharmaceutical plant inaugurated in January 2004 will employ 250 personnel from local and foreign nationalities when it becomes fully operational. TQM (total quality management) is the watchword and a way of life for the workforce. Sophisticated quality control laboratories with the latest computerised analytical equipments control and test every stage of formulation development and production from raw material stage to the finished and packed products and carry out in-process testing too. Special emphasis is laid on validation, stability studies and bio-clinical studies.
Complementing the instruments is a dedicated team of highly qualified and experienced scientists. Training and upgradation programmes keep the employees abreast of trends and demands in a dynamic regulatory environment.
Technical Documentation for Registration
Today's fiercely competitive and highly regulated markets demand rigorous design and management of product development and registration strategies for success. OPPC's team of highly qualified scientists and technical professionals have been made part of the regulatory process thus saving critical time in getting the product to the market, in optimum period, for submission to the regulatory authorities.
The Quality Assurance and Documentation Department provide services including:
Registration in Oman, GCC, European, United States Food & Drugs Authority (USFDA), as well as to the rest of the world.
Technical package containing pharmaceutical, clinical and therapeutic updates.
Site master file, abbreviated applications and dossiers.
Liaison with regulatory authorities for audits, inspection and technical queries.
Environment Protection
In keeping with local and international guidelines, OPPC has inducted precision control filters to achieve zero emission levels, and an effluent treatment plant and scrubbers to neutralise wastes through proper disposal. The plant is landscaped with trees and green lawns to provide maximum environmental protection.
Exports to MENA countries
OPPC has established high repute from its exports to the Middle East countries such as Iraq, Libya, Syria, Yemen etc.- Uma Devi Jadhav
'Very attractive for European companies to outsource products from Oman'
With 22 years of experience in the pharma business, Rajendra H Bhandari, General Manager of Oman Pharmaceutical Products Co. LLC (Zynova), has been with OPPC since its inception...Excerpts from his interview:
Which are the larger pharma plants in the GCC?
We are one of the large facilities in GCC. The other large facilities in GCC are Gulf Pharmaceutical Co (Julphar) based in the UAE, and Spimaco of Saudi Arabia, producing formulations.
How do you train your workforce?
We have consultants from the US, Germany, Switzerland and India every two-three months to impart training to all our employees. We also hire the services of Oman based trainers to train the Omani staff at our facility. Similar training has also been provided to Ministry of Health (DGPA&DC) Quality Control staff.
Where do you get your raw materials from?
As per the regulations of Ministry of Health (MoH), all the raw material producers need to be approved before importing any materials. We have to submit all the information such as CGMP status, COA, impurities profile, stability data from the supplier (producer) and only after evaluating the information, MoH allows us to import materials. At times, MoH visits the producer of raw materials and audits their facilities before granting the No Objection Certificate.
Why would multinationals want to come here to give contract manufacturing?
Oman has a very good infrastructure, and low labour-energy costs and taxes, as compared to Europe. All expertise is available from the Indian Subcontinent at lower costs as compared to Europe. Moreover, Oman has strict regulatory control, less hassles with regard to other commercial regulations and the pharmaceutical regulations are based on European guidelines. Hence, it becomes very attractive for European companies to outsource products from Oman.
Where is your machinery from? Is it second hand or brand new?
All brand new machines sourced from Europe, the US and India. The critical machines are from Europe, testing machines from the US, and the supporting machines and material handling equipment from India.
Why is your plant in Salalah? Do you get any subsidies for this location?
Salalah has an ultra-modern port having very good connectivity with all important ports. The weather too is not very hot. And we get no special subsidies at Salalah.
What's the advantage for Belgium PSI and Necura of Switzerland to go for tech-transfer with OPPC?
These parties can outsource their businesses to us at lower costs. Cipla has an advantage of selling their product to GCC by joining hands with us.
What are the export potentials for OPPC?
We are exporting to Yemen since December 2005. We have been approved by the GCC central committee, and Yemen is a member of this committee.- Uma Devi Jhadav
Infrastructure built as per the cGMP guidelines and adhering to the requirements of Oman's Ministry of Health, World Health Organisation's Good Manufacturing Practices (GMP), the United Kingdom's Medicine Control Agency (MCA), the European Union Regulations, the US FDA and other International Regulatory Authorities.
Implementation of the project by reputed consultants and contractors, selection of instruments from highly reputed manufacturers, international consultants to advise and evaluate in critical areas of validations, regulatory affairs and marketing.
Control and monitoring systems (CAMS) installed for the management of heat ventilaton and air conditioning, fire alarms and utilities.
Environment protection systems like dust collectors, scrubbers, effluent treatment plant and solid waste disposals in place.
Well trained and experienced staff appointed for formulation development, production, quality assurance, quality control and training departments, apart from engineering and administration.
Segregated and dedicated areas for products containing antibiotics, hormones and steroids.
Big League
Contract Manufacturing: Working closely with European generic companies to manufacture their products for the European markets. These companies are: Neolabs, UK for Paracetamol & Codeine combinations; Dragenopharm, Germany for Metformin Hydrochloride 850mg; Dee's Pharmaceuticals, UK for all range of topical formulations
Technology Transfer: Technology tie-ups with international companies such as PSI Belgium, Necura Switzerland, Cipla India, Concept Foundation of Thailand for launching new drug applications (NDAs) and improved versions of generic drugs in the GCC markets.
Global Dossiers: Product dossiers match international standards creating a huge opportunity of selling these dossiers in the international market.
Hormones & Steroids: A leader in this field the only facility in the GCC working to produce hormonal range of pharmaceuticals.
Contract Research: As Oman respects the Bolar provisions, the company has an opportunity to develop pharmaceuticals for the European markets for the generic companies.
Herbals & Nutraceuticals: Tied up with companies to market Nutraceuticals in the GCC.
Co-marketing: Tie-ups already in place with international companies to produce on a co-manufacturing basis, and then market these products in the GCC.
In-licensing: OPPC is working on a project to manufacture hormonal contraceptives under license from an international company.
Joint Ventures: OPPC is already in the final stages of signing an agreement with Cipla (India) to manufacture Cipla products for the GCC markets.
Some countries permit the manufacturers of generic pharmaceuticals to use the technology of a patented pharmaceutical to perform work that would assist in the marketing or regulatory approval of the generic product, while the patent is in force. This "Bolar" provision then allows the generic producer to market and manufacture their goods as soon as the patent expires. Bolar Provisions have been upheld as conforming to the Related Aspects of Intellectual Property Rights (TRIPS) agreement.
© Oman Economic Review 2006
