Aegant Laboratories Pvt Ltd provide services for API & Excipent sourcing, technology transfer, demonstration from lab scale to commercial scale, Regulatory filing and addressing FDA queries from US FDA, MHRA, EMA, ANVISA, CFDA, PMDA etc., and Qualitiy assurance and compliance audit of site & third parties for global regulatory agencies site clearance
A Seamless Partnership for your BULK API Needs
Aegant Labs bring technologies with competitive advantage and these services are part of the solution bringing your project one step closer to success.
Aegant Labs can provide technology for API manufacturing that is very cost competitive to Indian & Chinese manufacturers as well as formulation compositions & processes for India, and regulated markets. We have a portfolio of over 100 SKUs that can be explored for scaling your business. We provide complete project visibility on profitability in current market set-up and we are not just advocates of providing the paper technology, but we do hand-hold your team for execution to the defined target or provide our manpower to demonstrate from lab scale to commercial scale. Pl. connect with us for more information .
API Fabless manufacturing
A salient and exclusive feature of our service is to provide end-to-end support that include dossier compilation & regulatory filing assistance. If your company has limited internal resources for a full-fledged regulatory team or expertise in dossier compilation as per US DMF, CEP, WHO DMF, CADIFA, ANDA etc, we bring such expertise as part of our service package. We assist not only for filing your product dossiers, but also guide in addressing regulatory gaps or queries on submitted dossier.
Our experts can guide on different filings requirements like new NDA, 505(b)(2) NDA, paragraph IV projects for USA, We assist in planning your development starting from pre-clinical, clinical, toxicology, and CMC data generation as per EMA, and US FDA guidance.
Regulatory dossier support
Aegant Labs help our Domestic & Foreign organizations comply with US FDA, WHO, ANVISA, MHRA regulations. We have deep quality expertise in all types of good practices (GxPs). We assist clients with vendor qualification and selection and with auditing, review, and management of quality agreements, and we have first hand experience with the design, construction, and validation of manufacturing facilities No matter the size and the products manufactured.
Scope of Audit & compliance
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GMP Implementation (MDSAP/21 CFR 820, 21 CFR 111, 21 CFR 211, etc.)
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FDA Pre-Inspection/Mock Inspection.
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Third-party System Audits/GMP Audits.
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483 & Warning Letter responses.
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FDA DMF preparation & Submissions.
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FDA 510k Preparation & Submission
GMP Audit & Compliance support
What We Offer
We are doing custom synthesis of Impurities, Reference standards and other speciality chemicals. Our R&D facility is supported by experienced scientists as well as well-equipped analytical instrumentation. We undertake technical consultancy services for R&D and manufacturing units.
We provide API Reference & working standard as per EP / USP / BP / IP and other process related impurity, Pharmaceutical & Agrochemical Impurities, Custom Synthesis and Technical Services along with the complete COA which includes total analytical data within shortest possible lead times and competitive prices to support your research work in the best possible way. Pl. contact us with Impurity CAS Number or structure details in our contact form
Impurities and Standards
Aegant Laboratories offer APIs, Intermediates, Excipients, Neutraceuticals, & Herbal concentrates, meeting various pharmacopiea along with DMF or techpack for as per your markets regulatory needs. We also work on various supply models with exclusive supply agreements especially for US market for competitive advantage. We provide seamless support in qualifying APIs in your drug product dossiers for all markets, especially for more regulated markets like US and Europe, Middle East, Latin America (Brazil & Mexico), and Japan. Other largest markets are, African countries, Philippines, Indonesia, Vietnam, Thailand, Saudi Arabia, UAE, Qatar, Egypt, Iran, Jordan, Oman, Pakistan, Bangladesh, Thailand, Malaysia, Sri Lanka etc.