Fine Chemicals Is API manufacturing returning to Europe? Shannon Bennett of Thomson Reuters takes a look at the shifts in active ingredient sourcing During the past decade, as manufacturers have pursued lower costs and a more favourable regulatory environment, API sourcing has expanded from regulated into less regulated markets. However, sourcing from emerging markets has revealed a variety of challenges which pharmaceuticals companies are continuously working to overcome. These challenges, coupled with increasing costs in India and China and demand for specialised technologies, could steer some companies to return to sourcing their APIs from European suppliers. Regulatory developments Interest in the pursuit of the US generic drugs market …show more content…
The European Generics Association (EGA) recently requested consideration of an EU Bolar Export Provision. This would allow EU generic drugs companies to develop and manufacture products specifically for export to the global market without breaching existing EU patent protection. Such a provision would not only benefit EU companies by levelling the API playing field but would also facilitate the entry and availability of generic drugs in 'pharmerging ' markets, where the only available option may be more expensive branded drugs. The future of EU API manufacturing could be influenced by the outcome of other pending initiatives that would require more from companies in terms of investment in and oversight of suppliers. For example, the adoption of the EU 's Falsified Medicines Directive requires the verification of all finished dose packs throughout the supply chain, as well as for APIs exported to EU, proving they were produced within quality specifications equivalent to those in EU. Source: Robert Pollack, Lachman Consultants Figure 1 - GDUFA fees An additional requirement has been proposed which would require API manufacturers to verify the source of all starting materials, ensuring that they originated from the facilities claimed by the manufacturer of the starting materials. This could help EU manufacturers, as sourcing from European companies would require less paperwork and oversight than sourcing from India and China. Additionally, European companies may choose
Economic: Globalization of the pharmaceutical industry is an exciting opportunity to have research and development done at cheaper prices in other countries. However, this could be a double edged sword for companies because it is easy for other countries, such as India, to produce generic versions of the drug in bulk.
The NAICS code for pharmaceutical and medicine manufacturing in the U.S. is 32541 (census). However, Big Pharma’s product market can be further broken down into specialty drugs, brand name, generics, biosimilars, and over-the-counter medicines (Elis, 2016). According to Howard Morse, a partner at the international law firm Cooley, “the FTC has alleged markets ranging from those based upon a particular chemical compound, to broader markets based upon various drugs’ manner of interaction or dosage form, to still broader markets of all drugs used to treat a disease or condition” (Morse,
Global pharmaceuticals had presence in India since early 80’s and it was not until 1993 that Eli Lilly International decided to establish a Joint Venture with India’s second largest laboratory and exporter, Ranbaxy. This move happened in a very challenging context as both companies have very different profiles and backgrounds. The main differential characteristic was the nature of their products. While Ranbaxy was focused on generics and in other intermediate products, Eli Lilly International core business was the commercialization and development of new drugs through an aggressive R&D strategy. The trigger for Eli
On the other hand, generic companies’ primary activities include developing, producing, marketing, distributing, and gaining regulatory approval for generic drugs (Philips, 2014). While generic companies do engage in research and development (R&D), it’s goal is to create similar drugs that the brand name manufacturer just patented. If successful, the generic company files an Abbreviated New Drug Application (ANDA) for approval and must make a certification against each patent by the brand name manufacturer. To do this, the generic company must make a Paragraph IV certification which states that the patent is invalid or will not be infringed by the generic product (Fitzpatrick, Cella, Harper & Scinto, 2012).
Import duties can have an adverse effect on the end cost to the customer so these need to be taken in to account when presenting any quotes or tenders for work. The country of origin can be an issue with some of our customers as on occasion there has been expressed a reticence to trade with Indian produced products. The WTO and WCO guidelines and agreements on Rules of Origin allow us to move forward with contracts by dual production, this enables the company to produce products to a certain state of completion in India, then import to the UK branch and finish production giving the component a UK origin. Knowledge of the rules of origin agreed by the WTO alongside any Free Trade or Regional Trade agreements is necessary to evaluate the required work or percentage increase in value, or significant change in appearance to change the commodity code to enable this to be possible.
They had to do quality check and proper packing (palletization or crating) of the products to be exported.
India for that case has already established a global footprint, supplying generics to many countries . They are enthusiastic about the direction of their strategy – global expansion. The reason is simple as healthcare systems around the world are pushing for the use of generics. It is desired even in the USA as huge savings have been made in the healthcare system and penalties have been issued when generic prices rise ahead of inflation . Also, there is a positive forecast that generic usage will be increased close to 40% by 2020 . Knowing that exporting of generics is a lucrative part of the business, is also a big reason to why Indian companies and the government are beefing up the standards of pharmaceutical factories within the country . Strategies for global expansion are set out for long term goals, by being loyal to their plans, eventually the quality standards of ‘Pharmerging’ countries will be accepted
The global pharmaceutical industry is one that is seen to be riddled with misunderstanding and confusion; however, many of the questions emerging companies have can be answered by a thorough analysis of this industry and how these companies compare to one another on many different fronts. Analyzing the global pharmaceutical industry can bring to light how we in the United States compare on the grounds of industry attractiveness to our global counterparts.
The pharmaceutical industry has enjoyed very impressive sales and profit growth rate above 10 percent per annum despite its strict industry regulation. This success relied mainly on strong Research and Development (R&D), patents, aggressive promotional tool and Salesforce. In the era of big-bang disruption and economic downturn, however, this industry is constantly under attack from numerous interested parties trying to reduce the size of the drugs bill (Moss, 2004). This industry is now under immense pressure from external and internal stakeholders who are expecting development and distribution of pharmaceuticals and drug-related products and services in an ethical and cost efficient manner, yet maintaining healthy profit margins. As in other
The Global Innovative Pharmaceutical segment focuses on developing, registering and commercializing novel, value creating medicines that significantly improve patients’ lives.
India’s pharmaceutical market has been developing for many decades and represents value chain beginning from research and development and continuing with animal studies, clinical trials, approval and launch, manufacturing, marketing and distribution. Biocom had opportunities to take all the links of value chain to become the strongest market player and have full cycle production.
high growth rate – higher propotion of the global pharma market in the years to come
Pharmaceuticals have gradually evolved from an import-based industry to a self-manufacturing one exporting to 70 countries with a market size of over $750 million. Foreign investments either in the form of joint ventures with Bangladeshi companies or other partnerships whereby research and development is run in laboratories in India with complementing manufacturing plants in Bangladesh should be welcomed. These companies could utilize the competitively priced labor in Bangladesh and use cost advantages to capture the export market.
This report provides an analytical strategic review of the global pharmaceutical industry; its origin, evolution,