Enhancing Supply Chain Security for Levetiracetam API
Authors: AVT Reddy, Head - API Supply Chain; B Shivakumar, Product Manager - API
In this article we look at the factors, which can make an impact to ensure a reliable supply chain. Levetiracetam, one of the key APIs in our portfolios, is a model API, which shows how a diligent backward integration together with flexible capacities can enhance the security of the supply chain.
A brief background: Since 2017, the Chinese Government enforced environmental laws and regulations1) across the country to clean up air, water and upgrade its production efficiency. These regulations impacted numerous Key Starting Material suppliers resulting best case in a multifold price increase and worst case in a supply shortage. Our team at Dr Reddy’s implemented a diligent concept to tackle this situation in record time. The following 3 factors showed:
- Localization of KSM – Dr. Reddy’s entered into a strategic tie-up with China vendors and Indian business partners to transfer the technology/Know-how of KSM to India. Additionally, Dr Reddy’s further improved the technology in order to make it more sustainable by minimising the waste generation and re-using the solvents/reagents. Instead of shipping the KSM all the way from China, a local supplier can deliver faster and more flexible.
- Backed up by an alternative source – to further strengthen the supply chain, Dr. Reddy’s established another source for KSM in India. Following the same optimization principals as, mentioned above supplier has been qualified with approvals from global regulatory authorities including the USFDA and EDQM- in a record four months’ time.
- Scaling manufacturing capacities – To meet the increasing demand and to address the shortage, Dr. Reddy’s expanded the manufacturing capacity for Levetiracetam. The higher capacity ensures fastest turnaround times. Our process engineering team have developed crystallization processes and size reduction operations to meet customized physico-chemical properties such as, but not limited to, particle size, bulk density (tapped /untapped) .
Within three to four months our OTIF (on time and in full) performance increased to 100 % and so did customer satisfaction. Today, Dr Reddy’s has achieved a competitive position in supporting the global Levetiracetam API demands.
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Disclaimer:The scientific content of this article has been developed by Dr.Reddy’s Laboratories Limited (“DRL”) for educational and awareness purpose only. Although greatest possible care has been taken in compiling, checking and developing the content to ensure that it is accurate and complete, the authors, DRL, are not responsible or in any way liable for any injury or damage to any persons in view of any reliance placed on or action taken basis of the information in this article or any errors, omissions or inaccuracies and/or incompleteness of the information in this article, whether arising from negligence or otherwise. No part of the article including graphics available in this presentation may be copied or reproduced, in whole or in part, without the consent of DRL, other than for purposes permitted under fair use by copyright law.
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