The current trend of multiple European and US buyers moving away from China is expected to boost the API market of India. Moreover, the 'Make in India' initiative with backward integration of key intermediates, will further accelerate the low-cost API manufacturing in India. With the ongoing scenario, consistent delivery of excellent quality APIs at competitive rates, compliance with the requirements of the global drug regulatory agencies coupled with timely deliveries will be the key. To attain the same, API manufacturers are needed to level up their manufacturing facilities, with emphasis on developing a robust pipeline for quicker turnaround times.
Incorporated in 1984, Morepen specializes in API manufacturing and has obtained a niche place in the anti-histamine category, where it enjoys being the market leader in three products, i.e. the flagship product Loratadine, the second generation Desloratadine as well as Montelukast. Today, the firm holds more than 80 percent of the generic market share in the US In addition, it is the largest manufacturer of Loratadine globally.
According to Sushil Suri, CMD, Morepen, “At Morepen, we have an excellent track record on the
API deliverables, as the company adheres to the highest standards of manufacturing and compliances. Morepen has been successfully audited by multiple regulatory agencies over many years, including five times inspections by USFDA and emerging successfully with no critical 483 observations. The company continues to focus on following the best manufacturing practices and compliances to the regulatory requirements".
State-of-the-art API Manufacturing & Robust R&D
Morepen has developed two state-of-the-art API manufacturing facilities, both located in the state of Himachal Pradesh. These facilities are dedicatedly built to handle high-end chemical reactions under well supervised and controlled manufacturing conditions. The firm has also employed highly qualified and trained personnel to ensure the delivery of best-in-class products. Today, the APIs manufactured by Morepen have a global demand in both the non-regulated markets and the highly regulated markets like the US, EU, Japan and others.
The R&D skills of Morepen have been the key factor influencing the company’s growth. Through its R&D, the firm works to accomplish multifaceted developments like - non-fringing processes and patents, developing new polymorphs, designing cost-effective processes, impurity proofing, and multi-stage synthesis, and others. Its strength has been complex chemistry skills and its control of high-intensity, sensitive, and dangerous but controlled chemical reactions such as the Grignard Reaction, Friedel-Craft Reaction, Stereo selective Chiral Reaction, Heck and SN2 reaction, ranging from 3KL to 5KL reaction volume.
Pathway to the Future
Today, Morepen is continuously working on cost reduction, new process patents, input substitution, and another variable to service better to its customers.
“The company will exploit its immediate pipeline of multiple APIs under various therapeutic categories, subject to patent expiry, comprising Anticoagulants like Apixaban, Edoxaban, Rivaroxaban, Diabetic management molecules like Linagliptin, Dapagliflozin, Saxagliptin, Canagliflozin, Vildagliptin, Alogliptin, Saroglitazar and Ertugliflozin. Its product pipeline also includes anti- depressant Vortioxetine and gout treatment drug Febuxostat", points out Suri.
In the days to come, Morepen is set to upgrade its R&D capabilities wherein the firm will work on multiple products which are going off patent so that it could be amongst the first few API suppliers which could fulfill the API needs of the formulators. Additionally, the firm is collaborating with formulators to provide captive supply, as well as partnering with marketing companies in US markets to ensure a robust supply chain.
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