Built on a Foundation
of Quality
Every medicine we manufacture meets the highest international standards — from raw material sourcing to final packaging and distribution.
Quality is Not a Department — It's Our Culture
At Shomam Pharma, quality assurance is embedded at every stage of our manufacturing process. Our state-of-the-art facilities in Mumbai operate under strict WHO-GMP guidelines, ensuring that every batch we produce is safe, effective, and consistent. We invest continuously in technology, training, and infrastructure to uphold the trust placed in us by healthcare professionals and patients worldwide.
Internationally Recognised Standards
Our certifications reflect our unwavering commitment to global pharmaceutical quality benchmarks.
World Health Organization — Good Manufacturing Practice
Our manufacturing units are WHO-GMP certified, enabling us to supply to regulated and semi-regulated markets across Asia, Africa, and Latin America.
Quality Management System
ISO 9001:2015 certification validates our systematic approach to quality management, continuous improvement, and customer satisfaction.
Environmental Management System
We are committed to sustainable manufacturing practices, minimising environmental impact across all our production facilities.
European Union GMP Compliance
Our facilities comply with EU GMP directives, enabling export of pharmaceutical products to European markets.
Central Drugs Standard Control Organisation
All our products are registered and approved by India's CDSCO, ensuring full regulatory compliance within the domestic market.
US Food & Drug Administration Standards
Our quality systems and documentation practices are aligned with USFDA requirements, supporting our global expansion strategy.
State-of-the-Art Manufacturing Infrastructure
Our Mumbai-based manufacturing campus spans over 120,000 sq. ft. with dedicated production blocks for each dosage form.
Dedicated production lines for tablets and capsules with automated granulation, compression, coating, and blister packaging. Capacity: 500 million tablets/year.
Fully enclosed liquid manufacturing suites with automated filling and sealing lines for oral liquids, syrups, and suspensions.
Class 100 (ISO 5) cleanroom environment for sterile injectable manufacturing, including lyophilisation and aseptic filling capabilities.
Fully equipped QC lab with HPLC, GC, UV-Vis spectrophotometry, dissolution testing, and microbiology suites for in-process and finished product testing.
From Raw Material to Patient — Every Step Controlled
Raw Material Sourcing
All APIs and excipients are sourced from approved vendors. Every incoming material undergoes identity testing, purity analysis, and Certificate of Analysis verification before release.
In-Process Quality Control
Dedicated IPQC teams monitor critical process parameters at every stage — granulation, compression, coating, and filling — ensuring batch consistency and compliance.
Finished Product Testing
Each batch undergoes comprehensive testing including assay, dissolution, uniformity of content, microbial limits, and stability studies before release.
Packaging & Labelling
Automated packaging lines with vision inspection systems ensure correct labelling, tamper-evident sealing, and serialisation for traceability.
Stability Studies
Long-term and accelerated stability studies are conducted under ICH guidelines to validate shelf life and storage conditions for every product.
Dispatch & Cold Chain
Temperature-controlled warehousing and GDP-compliant logistics ensure product integrity from our facility to the end customer, anywhere in the world.
Reliable Supply, Every Time
Shomam Pharma maintains strategic raw material inventory buffers and redundant supplier relationships to ensure uninterrupted supply to our hospital and institutional clients. Our ERP-integrated supply chain provides real-time visibility across procurement, production, and dispatch.
Vendor Qualification
All suppliers undergo rigorous qualification audits covering quality systems, regulatory compliance, and financial stability.
Inventory Management
ERP-driven inventory management with 90-day safety stock for critical APIs ensures zero supply disruption.
Cold Chain Logistics
GDP-compliant temperature-controlled distribution network covering 40+ countries with real-time monitoring.
Serialisation & Track-Trace
Full product serialisation and track-and-trace capabilities meeting EU FMD and India's drug traceability requirements.
Need quality documentation or regulatory dossiers?
Our regulatory affairs team is ready to assist with all compliance requirements.
