Company Profile

Certification


PT Ferron PAR PharmaCeuticals First Shipment To Europe

 

European markets, particularly the UK market is "highly regulated" which is very strict in terms of quality, so it is not easily penetrated by a local pharmaceutical player. Therefore, this event represents a new milestone not only for PT Ferron PAR Pharmaceuticals, but also for the pharmaceutical industry in Indonesia in general.

The success of entering the UK market, also has opened opportunities to other European markets for the company in the shade of Dexa Medica Group. "One more, important milestones that will be recorded in the history of PT PAR PharmaCeuticals Ferron (Ferron), namely: First Shipment to Europe. Viewed from its commercial value, are far from fantastic, be it for Ferron, especially for the pharmaceutical industry of Indonesia, "said Managing Director of PT Ferron PAR Pharmaceuticals, Djoko Sujono when giving a speech at the Prime Exports to Europe, in factories Ferron Cikarang, West Java.

At the event also gave a speech the Head of NAFED, Bachrul Chairi, and Deputy First Field Controlled therapeutic and addictive drugs, BPOM, Lucky S. Slamet, who represents the Head of BPOM.

However, continued Djoko Sujono, when viewed from the aspect of their pioneering work, this momentum is a very important event. Not only for the Ferron, but also has strategic significance for the pharmaceutical industry of Indonesia. A proof, that the product of the national pharmaceutical industry, can penetrate the European market.

Djoko Sujono add a small step from this Ferron, will be the beginning of a great achievement for the generic pharmaceutical industry of Indonesia, which has been circumscribed by the paradigm itself, to remain outside the market "regulated". "The success of Ferron penetrate the British market, is an achievement in itself," said Djoko Sujono.

This success is by taking into account the following factors:
•   The strict regulatory requirements for entering the European pharmaceutical market. Generally accepted paradigm states, that the regulatory requirements of the 'sophisticated', far from the reach competency pharmaceutical factory Indonesia.
•   Competitive UK market, makes the assumption, that the Indonesian pharmaceutical industry that has no industrial base of raw materials may not be able to compete.
•   Age Ferron in the Indonesian market, currently has just reached eight years in the domestic market.

Djoko Sujono Ferron add this achievement, does not come suddenly. Three years more, Ferron seeks to understand the factors that needed to enter the European market. Price competitiveness, it is an important element. But not the only one. Production facility with the System and Culture of good quality, and product development competencies that 'comply' with the rules regulations and standards prevailing in the European region, it is no less important. It is all achieved through a long learning process and often exhausting.

Support from parent organizations, namely Dexa Medica Group, which has a high commitment and extensive networks, certainly was instrumental in this effort. Sourcing of raw materials that meet quality requirements, have a good supporting documents, free of IPR issues, with prices that are still competitive, would not ever be done without the network which has long built by Dexa Medica Group.

Also, to build the competencies of product development in accordance with the new regulatory habitat, certainly can not run fast without the infrastructure R & D, and competent human resources result of long efforts of a group that is very 'committed' in the field of pharmacy.

Similarly, the overall effort to build quality infrastructure, and infrastructure, product development, this course involves an investment is not small in terms of: training, consulting, systems development (including IT), building and production equipment, and laboratory. Once again, support and vision of top management was instrumental in supporting this achievement.

The whole process of adaptation, and learning to adjust to new things that are accepted by all employees, as a challenge to develop themselves, and not as load changes. This is all that makes the achievement that can be run relatively quickly.

Certificates UK-MHRA & Export Prime to Europe
Beginning in 2008, the results of all the struggle that began to appear. In January 2008, an audit of the MHRA (Medicine and Healthcare Products Regulatory Agency), local authorities in dealing with drug problems in England, carried out with satisfactory results. In March 2008, Ferron get GMP certificate from the MHRA for Solid dosage. And finally, today, Monday, July 21, 2008, Ferron was able to prove actual delivery of the products the first time (prime) to England.

In accordance with prevailing regulations, by entering into the UK market, export markets also opened the door to countries other EU. Therefore, the results of inspections of production facilities Ferron recognized by these countries. Furthermore, live how Ferron looking for buyers in other countries.

By coincidence, the UK has a strategic value for the generic business in the regulated market. First, because the UK market is very competitive, so as if we can compete in this country, it can definitely be able to compete in another regulated market. In addition, the MHRA is an agency inspectors in the world, so that the passage of Ferron from MHRA inspection will give you a sense of greater confidence to go into another regulated market.

Prime shipping to Europe will also be a proof, and while creating a new paradigm that generic producers in Indonesia can compete and be able to enter the European market is tight. In addition, in parallel happen Indonesian human resource development competencies that became the basis for further achievements.

Of course, Ferron still have to prove to grow in the European market, and other regulated markets, the potential market is huge. The EU is the world's second largest market with a market share of around 24% (after the U.S. = 47%, followed by Japan in third place = 12%).

Further development can only take place, if there is a supportive regulatory infrastructure, which concerns the provisions in the regulation of importation of raw materials, to speed the issuance of a special distribution license for the export product.

In the end, expect what has been achieved by Ferron will be followed by the generic industries in Indonesia the other, so that ultimately will shape the international confidence in the pharmaceutical industry in Indonesia. This small step for a company be a quantum leap Marshall for the pharma industry in Indonesia.