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Government Calls for investment in Indian Pharma Sector
New Delhi: The Union Minister for Chemicals and Fertilizers D. V. Sadananda Gowda has said India is one of the largest manufacturers and exporters of generic medicines across the world. During initial phase, he said, HCQ and Azithromycin was identified as one of medicines under treatment protocol for covid-19 in emergency cases. Referring to India supplying these medicines to more than 120 countries across the world, he underlined that india thereby earned the reputation of reliable supplier of medicines. Gowda informed that India is the only country with largest number of US-FDA compliant Pharma plants (more than 262 including APIs) outside of USA with exports $ 20 billion worth of pharma products to various countries including high standards complying countries like US and Europe. Addressing the virtual Latin America & Caribbean session on ‘Reimagining Distances’, during LEADS 2020, organised by FICCI, Gowda said that Indian pharma sector can grow to $ 65 billion industry by 2024. "We have recently launched schemes for development of seven mega parks—three bulk drug parks and four medical devices parks across country. New manufacturers will be eligible for Production Linked Incentive (PLI) Scheme under which they will be eligible for financial incentives on basis of their sales for first 5-6 years," Gowda said. The Minister further emphasised that this is a very- very good time to invest, and set up manufacturing base in India in pharma sector. "One can enter India market through Joint Ventures also. The advantage is that you can get access to big markets like domestic Indian market, US, Japan, EU and South East Asia through India as far as pharma sector is concerned. Any body can contact my office if they are interested in Indian pharma sector, we will provide all possible facilitation and hand holding," he stressed.

 


 
Glenmark Pharma Gets USFDA Nod to Market Drug for Relapsing Multiple Sclerosis
Mumbai: Drug major Glenmark Pharma said it has received final approval from the US health regulator for Dimethyl Fumarate delayed-release capsules, used for treatment of relapsing forms of multiple sclerosis in adults. The approved product is a generic version of Biogen Inc’s Tecfidera delayed-release capsules. Glenmark Pharmaceuticals Inc., USA, has been granted final approval by the United States Food and Drug Administration (USFDA) for Dimethyl Fumarate delayed-release capsules in the strengths of 120 mg and 240 mg, Glenmark said in a regulatory filing. Quoting IQVIA sales data for the 12 month period ending August 2020, Glenmark said Tecfidera delayed-release capsules, 120 mg and 240 mg, market achieved annual sales of approximately USD 3.8 billion. Glenmark said current portfolio consists of 164 products authorised for distribution in the US marketplace and 46 abbreviated new drug applications are pending approval with the USFDA. Shares of Glenmark Pharma were trading at Rs 494.85 per scrip on the BSE, up 0.94 per cent over previous close.

 


 
Approvals of COVID-19 Biologics Will Put Huge Pressure on Large-Scale Bioprocessing Networks
Amsterdam: The third part of the 2020 CPhI Annual Report – released during the second week of the CPhI Festival of Pharma (5-16 October, 2020) – predicts, that if approved, COVID vaccines and therapeutics will cause an impending bio-manufacturing capacity challenge, particularly for large scale reactors. CPhI Annual Report expert, Dawn M. Ecker – Managing Director of bioTRAK Database Services at BDO – explores the medium- to long-term implications of supply and demand for biologics manufacturing. Her findings show that short-term capacity concerns have eased, but beyond 2024 we may see capacity challenges. The primary variable in future commercial capacity needs will be the progress of Alzheimer’s drugs, PDL/PDL-1 checkpoint inhibitors and Covid therapeutics currently in late stage development. Ecker reports that global bio-manufacturing capacity will increase to 6500kL by 2024 at a CAGR of 6.4% – up from 4700kL in 2019 – but capacity demand is rising faster and will reach 4700kL in 2024 at a CAGR of 12%. “Should indications such as treatments for Alzheimer’s disease or broad cancers obtain regulatory approval, a significant increase in demand for manufacturing capacity could occur, potentially leading to a serious capacity shortage. We also face an additional challenge of incorporating demand for recombinant proteins to combat COVID-19. We conservatively estimate that the demand for these products could require approximately 30 metric tonnes per year – so this potential demand will add significant pressure to manufacturing networks with large-scale capacity,” commented Ecker. The report also explores the continuation of recent manufacturing trends with geographical shifts underway; a changing demand in the scale of reactors; and how capacity is moving from big pharma towards CMOs and hybrids (those that make internal excess capacity available to outside developers). Current reactor scales coming online reflect previous priorities for R&D and small volume products. As such, only 20% of the new bioreactors projected by 2024 will be of 10,000L size, whilst 50% will be of 2000L scale. Yet Ecker’s models suggest the most probable scenarios will see half of phase II and III products requiring a bioreactor capacity of 10,000L to meet demand – and COVID-19 products will undoubtedly require multiple large-scale bioreactors. The challenge here is that much of the new bioreactor installations reflect a pre-pandemic demand profile. In terms of access, currently around 70% of bioprocessing capacity is owned by product developers, with CMOs and hybrid companies providing the remainder. This potentially means innovators without in-house manufacturing may have difficulty accessing capacity as their products move towards commercial scale. Ecker states that the distribution of capacity will continue to change over the next four years, with CMO/hybrid capacity share increasing to 36%. In terms of geographic spread of capacity, Europe will equal North America for total bio-manufacturing capacity by 2024, with Asia also expanding. “Over the last five years there has been modest capacity growth in North America and Europe, with significantly greater growth in Asia. The next few years, however, will see significant growth rates projected in both Asia (~7%) and Europe (~12%), and by 2024 Europe will have equivalent capacity to the USA for the first time,” added Ecker. “Looking deeper at the country level, particularly Korea, Singapore and Ireland, we see that growth here reflects government incentives and tax advantages, amongst other factors.” Tara Dougal, head of content at CPhI Festival of Pharma added: “What this report highlights is that the partnerships early-stage innovators establish now with CMO and hybrid companies will become increasingly important as new capacity challenges emerge in the next few years. With capacity also now spread globally, it means that pharma companies need to be increasingly international in their approach to sourcing and I would encourage the industry to use the CPhI Festival of Pharma to start building those vital connections. The event’s digital nature has enabled us to bring increased insights in a variety of formats, as well as partners from all corners of the globe. Our event and the findings in the annual report will help deliver competitive advantages for all stakeholders in the pharma supply chain.” Download a copy of the CPhI Annual Report on Global Pharma Insights. An in-depth analysis of this year’s CPhI Annual Report is also provided in a podcast debate featuring Dawn Ecker, as well as Fiona Barry, Associate Editor, PharmSource, a GlobalData Product, and Dan Stanton founder and editor of BioProcess Insider.
Summary of Findings
Dawn M. Ecker, Managing Director of bioTRAK Database Services, BioProcess Technology Group – Bioprocessing trends overview 2020 – 2024.
Demand for biologics manufacturing by volume is projected to reach over 4700kL, a 5-year growth rate of over 10% per year
If Alzheimer’s drugs and PDL/PDL-1 checkpoint inhibitors are approved, demand could be much higher resulting in capacity shortages in a typical forecast. However, if approved, COVID 19 therapies and monoclonal antibody-based infection preventatives could cause significant pressure to large-scale manufacturing networks
Global biologics manufacturing capacity will increase to 6500kL by 2024 from nearly 4700kL in 2019
CMO/hybrid companies increase their control of capacity from 33% in 2019 to 36% in 2024 and by 2023, Europe will have capacity equivalent to North America. Capacity in Asia continues to grow.
Half of the typical products in late phase development can be met by a single 2000 or 5000L bioreactor, but half of these products, as well as COVID-19 therapies, will require large-scale bioreactors of 10,000L
Overall, capacity should experience some loosening in the short-term, but may tighten after 2024 – the approval of COVID-19 therapeutics and preventatives would also place significant pressure on large-scale manufacturing facilities
Despite some shift in capacity distribution the majority of capacity will remain in-house, which may cause capacity issues for product developers that lack internal manufacturing capabilities
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