We adopt phase appropriate development strategies and adhering to quality requirements tailored to the molecule’s development stage, expediting drug substance supply from Pre-Clinical to First-In-Human (FIH). Our versatile manufacturing facility delivers quantities from kilograms to multiple kilograms, reflecting our dedication to meeting client needs promptly and efficiently, ensuring top-quality drug substances.
We adopt phase appropriate development strategies and adhering to quality requirements tailored to the molecule’s development stage, expediting drug substance supply from Pre-Clinical to First-In-Human (FIH). Our versatile manufacturing facility delivers quantities from kilograms to multiple kilograms, reflecting our dedication to meeting client needs promptly and efficiently, ensuring top-quality drug substances.
Stability studies are integral to ensuring the quality and shelf-life of pharmaceutical products at LAXAI. Our comprehensive testing regimes evaluate how various factors affect product efficacy over time, providing crucial data for regulatory submissions and product development.
Our service offers a complete suite of ICH stability studies for small molecule APIs, including:
Our services span from pre-Clinical stages to First-in-Human supplies, ensuring seamless progression with GMP-compliant batches. We specialize in Tox Batches and FIH GMP Batches, leveraging cutting-edge technology to meet rigorous safety and efficacy standards, setting a solid foundation for successful clinical trials.
Our late-phase and commercial manufacturing services are designed to scale up production without compromising on quality or efficiency. From tech transfer and process validation to full-scale commercial production, we provide a comprehensive suite of services to support the successful launch and ongoing supply of pharmaceutical products.
Tech transfer at LAXAI is a meticulously planned and executed process, ensuring the seamless transfer of production from development labs to commercial-scale facilities. Our team specializes in adapting processes to new environments while maintaining product quality, efficiency, and compliance with regulatory standards.
Process validation is critical to our manufacturing services, ensuring that every production run meets the predefined quality criteria. Our validation processes are robust and comprehensive, covering everything from initial design to routine production, guaranteeing consistency, safety, and efficacy of the pharmaceutical products.
Our regulatory filing services streamline the approval process for pharmaceutical products. Our team of experts navigates the complex regulatory landscape, preparing and submitting the necessary documentation to regulatory bodies worldwide, ensuring compliance and timely approval.
Our contract manufacturing services offer flexibility and expertise for companies seeking to outsource their production needs. LAXAI's facilities are equipped to handle a wide range of pharmaceutical products, offering custom manufacturing solutions that meet our clients' specific requirements.
We provide high-quality key starting materials (KSM) essential for the synthesis of complex molecules. Our global sourcing capabilities and stringent quality control measures ensure the purity and reliability of our KSMs, supporting efficient and successful drug development.
Our regulatory starting materials (RSM) are produced with the utmost attention to regulatory compliance and quality standards. We offer a secure supply of RSMs, critical for the synthesis of APIs, ensuring that our clients' manufacturing processes are efficient and compliant.
We specialize in the production of advanced intermediates, offering custom synthesis services to meet the unique needs of our clients. Our advanced intermediates are key components in the manufacture of complex APIs, ensuring quality and reliability throughout the drug development process.
Our expertise in synthesizing active pharmaceutical ingredients (APIs) is unmatched. With state-of-the-art facilities and extensive technical know-how, we produce high-quality APIs that form the cornerstone of effective and safe pharmaceutical products.
Stability studies are integral to ensuring the quality and shelf-life of pharmaceutical products at Laxai. Our comprehensive testing regimes evaluate how various factors affect product efficacy over time, providing crucial data for regulatory submissions and product development.
Our quality assurance and regulatory support services are the backbone of our manufacturing operations. We ensure that all products meet the highest standards of quality, safety, and efficacy, while our regulatory team provides expert guidance through every stage of the product life cycle, from development to market.
3rd Floor, Ventureast Plaza, Financial District, Nanakramguda, Hyderabad, 500032, Telangana, India
Plot No. 9/A Phase III, IDA Jeedimetla, Hyderabad, Telangana 500055, India
Building 900, Synergy square I, Genome valley, Turkapally, Shameerpet, Hyderabad, Telangana 500078, India
533 Airport Boulevard Suite
400, Burlingame, CA 94010
Interested in working with us?
+91 40 6111 6888
Plot No. 9/A Phase III, IDA Jeedimetla, Hyderabad, Telangana 500055, India
3rd Floor, Ventureast Plaza, Financial District, Nanakramguda, Hyderabad, 500032, Telangana, India
Building 900, Synergy square I, Genome valley, Turkapally, Shameerpet, Hyderabad, Telangana 500078, India
533 Airport Boulevard Suite
400,Burlingame, CA 94010
Interested in working with us?
+91 40 6111 6888
