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Commercial Manufacture

Commercial Manufacture
Clinical Trial Supplies Manufacture

We fully understand the critical importance of time, quality and economics in pharmaceutical development. Our process R & D, QC analytics, manufacturing teams and project champions work hand-in-hand with customers to produce regulatory starting materials, intermediates and APIs for Phase I, II & III clinical trials in kilo gram to metric tonne quantities. Arch Pharmalabs project management systems enable transparent milestone tracking, communications and delivery.

Process Validation

Arch Pharmalabs product development and commercialization track record offers customers and partners a unique opportunity to leverage our expertise and experience in process validation and launch planning. Our New Product Introduction teams work closely with customers to plan and execute a safe, cost-effective and risk-mitigated validation strategy. Our regulatory team provides all API CMC- and / or DMF-related supporting documentation and assistance to enable smooth filings.

Launch Planning & Post-Approval Commercial Manufacture

Arch Pharmalabs offers multiple cGMP-complaint and ISO-certified Assets in India to provide our customers post-approval, market place requirements of regulatory starting materials, intermediates and APIs in a reliable, quality-focused and economical manner. Applying world-class best practices, our production, quality and supply chain teams work diligently to enable customers' launch and post-approval commercial supply programs on a global basis. Arch’s sites possess approvals from global regulatory bodies such as the USFDA, EDQM, TGA and PMDA.