DWG NO. MOI-1960 · ISO 9001:2015 · REV 66
Indian Pharma Company Achieves GMP Compliance
How MedCura Pharmaceuticals transformed from manual capsule filling to automated, GMP-certified production with a 10x throughput increase.
Manual Processes, Inconsistent Quality, and a Compliance Deadline
MedCura Pharmaceuticals Ltd., a growing Indian pharmaceutical company specialising in nutraceutical and generic capsule formulations, faced a challenge that threatened their expansion plans. Their capsule production relied heavily on semi-automatic filling machines and manual secondary packaging. At best, they produced around 100 capsules per minute with a team of eight operators working in shifts.
The problems extended well beyond speed. Fill weight consistency was unpredictable, with batch-to-batch variation exceeding acceptable pharmaceutical tolerances. Capsule rejection rates ran at 8-12%, translating to significant raw material waste and rework costs. Every rejected batch meant wasted gelatin, wasted active ingredients, and wasted production time.
Most critically, MedCura had secured a contract to supply capsules to a major distributor in the Middle East, a market that demanded full GMP compliance. Their current production setup could not meet these regulatory standards. The dipping, drying, trimming, and sorting processes lacked the automation, repeatability, and traceability that GMP certification requires. Without upgrading their equipment, MedCura would lose the contract and the export market opportunity entirely.
The deadline was tight. They needed to be GMP-certified and producing at scale within six months to fulfill the export contract. European capsule machine manufacturers quoted 12-18 month lead times and prices that would consume most of MedCura's available capital. They needed a solution that was fast to deploy, affordable, and built to pharmaceutical standards.
Automated Capsule Production with GMP-Grade Engineering
MOI Engineering Private Limited proposed the ACM-XFH 1050, an automatic hard gelatin capsule making machine that integrates the entire manufacturing process from gelatin dipping through to finished, trimmed capsules at up to 1.8 million capsules per day. The machine's GMP-compliant stainless steel construction was specifically designed to meet the regulatory standards MedCura's export markets demanded.
The ACM-XFH 1050 automates six production stages that MedCura had previously performed manually or semi-automatically: dipping, spinning, drying, stripping, trimming, and sorting. Each stage includes precision controls that maintain consistent capsule dimensions, wall thickness, and moisture content across sizes 00 through 5. The integrated process monitoring provides real-time visibility into production quality, generating the batch documentation and traceability records that GMP auditors require.
To complete the secondary packaging automation, MOI also supplied the BOSS boxing system for strips. The BOSS automates the collation, orientation, counting, and boxing of capsule strips, eliminating the manual packaging bottleneck that had previously required six dedicated operators. Together, the two machines created a continuous production flow from raw gelatin to boxed, distribution-ready product.
MOI's installation team completed the setup in three months, including utility connections, calibration, and validation runs. A two-week operator training programme ensured MedCura's production team was fully proficient on both machines before handover, with comprehensive documentation provided for ongoing SOPs and maintenance schedules.
The Results
From manual filling to GMP-certified automated production
From Domestic Supplier to Export-Ready Manufacturer
The transformation at MedCura went beyond production metrics. The 99.8% fill weight accuracy eliminated the batch consistency issues that had previously caused rejection rates of 8-12%. Capsule dimensions were now uniform across every production run, meeting the tight tolerances that pharmaceutical distributors and regulators demand.
The 35% reduction in raw material waste had an immediate impact on production economics. Less wasted gelatin, fewer discarded capsules, and reduced rework time meant lower cost per unit. Combined with the 10x throughput increase, MedCura's per-capsule production cost dropped significantly, improving margins even as they met the higher quality standards required for export.
The GMP certification audit was completed successfully within four months of installation. The automated process controls, batch documentation, and stainless steel construction of the ACM-XFH 1050 addressed every compliance requirement. MedCura fulfilled their Middle East export contract on schedule and has since expanded into two additional international markets.
The BOSS boxing system reduced secondary packaging labour from six operators to one supervisor, freeing five team members for quality control and upstream process roles. The automated strip boxing eliminated counting errors and orientation mistakes that had previously caused distribution returns.
"The ACM-XFH 1050 has optimized our capsule production process with impressive precision, speed, and efficiency. We went from struggling with GMP compliance to passing our audit on the first attempt. The machine paid for itself within the first export contract."
Machines Used in This Project
Two machines delivering a complete capsule production and packaging solution
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