Pregabalin API
CAS Number: 148553-50-8
About Pregabalin API
Therapeutic Category
Central Nervous System (CNS)
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
Mechanism of Action
"LYRICA (pregabalin) binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha2-delta subunit may be involved in pregabalin's anti-nociceptive and antiseizure effects in animals. In animal models of nerve damage, pregabalin has been shown to reduce calcium-dependent release of pro-nociceptive neurotransmitters in the spinal cord, possibly by disrupting alpha2-delta containing-calcium channel trafficking and/or reducing calcium currents. Evidence from other animal models of nerve damage and persistent pain suggest the anti-nociceptive activities of pregabalin may also be mediated through interactions with descending noradrenergic and serotonergic pathways originating from the brainstem that modulate pain transmission in the spinal cord. While pregabalin is a structural derivative of the inhibitory neurotransmitter gammaaminobutyric acid (GABA), it does not bind directly to GABAA, GABAB, or benzodiazepine receptors, does not augment GABAA responses in cultured neurons, does not alter rat brain GABA concentration or have acute effects on GABA uptake or degradation. However, in cultured neurons prolonged application of pregabalin increases the density of GABA transporter protein and increases the rate of functional GABA transport. Pregabalin does not block sodium channels, is not active at opiate receptors, and does not alter cyclooxygenase enzyme activity. It is inactive at serotonin and dopamine receptors and does not inhibit dopamine, serotonin, or noradrenaline reuptake."
Indication
LYRICA is indicated for:
- Neuropathic pain associated with diabetic peripheral neuropathy (DPN) • Postherpetic neuralgia (PHN)
- Adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older
- Fibromyalgia
- Neuropathic pain associated with spinal cord injury
Dr. Reddy's Expertise
Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Pregabalin API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.
Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Pregabalin API is the outcome of the extensive expertise in R&D, IP, and Regulatory.
A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.
Related Resources
Dr. Reddy’s is improving supply chain performance for Pregabalin API through large manufacturing capacity and backward integration
The global pharmaceutical industry is currently challenged by uncertain or disrupted API supplies, which is impacting their ability to serve patient needs. At Dr. Reddy’s, we are strongly committed to de-risk the supply chain management to ideally support the API needs of our customers.
Pregabalin is one of the key APIs in Dr. Reddy’s portfolio and in our endeavour to be one of the most reliable API suppliers worldwide, Dr. Reddy’s is following a structured approach to tackle this uncertainty. The access to one of the largest manufacturing facilities dedicated to the production of Pregabalin APIs, combined with a backward integrated supply of advanced intermediates, will give our customers the advantage of a de-risked supply chain for an on time and in full delivery.
How Dr. Reddy’s is catering to its customers’ specific needs and reducing supply management risks:
1. Extensive capacities and capabilities: With a capacity of over 180 MT, Pregabalin API is manufactured at an automated manufacturing line that uses a distributed control system. This allows tighter control over all quality parameters including particle size distribution. This gives us the ability to cater to a wide range of customer PSD requirements - d(90) : 50 to 800 microns.
2. Backward integration and supply chain visibility: The backward integration of intermediates facilitates stable supplies with stringent quality control across the whole synthesis route. Depending on customers’ requirements, we can meet delivery lead times of less than 90 days.
3. Large batch size: Our batch size of 1000 kg economizes analytical batch testing for our customers and provides order flexibility.
How can we meet your Pregabalin API needs? Please write in to us at api@drreddys.com with your requirements or fill the enquiry form below.
Explore our Pregabalin API offering by clicking on the link below:
https://api.drreddys.com/product/pregabalin
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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