Anticonvulsant or anti-epileptic.
Drug Class
The synthetic process for Lamotrigine API uses readily available benzoyl cyanide as KSM
API Technology
Commercialized.
Development Status
US/EU/ANVISA
Regulatory Fillings
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IOLCP’s Footprint in Lamotrigine API
IOL Chemicals and Pharmaceuticals Limited is a trusted manufacturer of Lamotrigine API, supported by a fully backward integrated process that enables production across various PSD grades within the same manufacturing system. With an installed capacity of 24 MT per annum, IOLCP follows Pharmacopeial and ICH requirements to deliver consistent quality and meet the expectations of regulated global markets. This manufacturing capability strengthens our standing in the Lamotrigine API market and adds further credibility to our Lamotrigine API price through regulatory readiness, product consistency, and dependable supply.
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- IOLCP uses a fully backward integrated process that allows for the production of Lamotrigine in various PSD grades within the same production process.
- IOLCP's Lamotrigine manufacturing meets the highest quality standards, adhering to Pharmacopeial and ICH requirements. This guarantees that our API meets global requirements and maintains a strong leadership position.
- Lamotrigine uses includes its effective prevention and control of seizures. The Lamotrigine API is either used alone or in combination with other medicines to offer a significant therapeutic benefit for epilepsy patients.
Indication
Lamotrigine API is used as adjunctive therapy for seizures and is indicated for the maintenance treatment of bipolar I disorder, delaying the time to mood episodes (which may include mania, hypomania, depression, and mixed episodes) in adults.
Lamotrigine, as an active pharmaceutical ingredient is used alone or with other medications to prevent and control seizures.
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Frequently Asked Questions
Yes, IOLCP, a leading Lamotrigine API manufacturer, offers comprehensive support for regulatory filings. Our highly qualified team of experts assists with the necessary Lamotrigine API data and documentation, streamlining the approval process in various markets for regulatory compliance.
Yes, as a reputable Lamotrigine API manufacturer, IOLCP understands the importance of product stability under various conditions. We ensure that all our products undergo rigorous testing to maintain their quality and stability, meeting the standards expected by our clients and regulatory bodies.
IOLCP offers flexible order options for Lamotrigine API without any set minimum order quantity (MOQ). With a robust production facility capable of producing 180 Metric Tonnes Per Annum (MTPA), we can efficiently handle both smaller and larger orders to meet your specific requirements.
As a trusted Lamotrigine API manufacturer, IOLCP maintains strict compliance with current Good Manufacturing Practices (cGMP) throughout its production process. The facilities are designed to meet rigorous standards of high-quality API manufacturing for global distribution.