Home/Quality & Manufacturing

Built on a Foundation
of Quality

Every medicine we manufacture meets the highest international standards — from raw material sourcing to final packaging and distribution.

Our Commitment

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.

25+
Years of GMP Compliance
98.7%
Batch Pass Rate
40+
Countries Supplied
500+
Products Certified
Quality control laboratory at Shomam Pharma
Certifications

Internationally Recognised Standards

Our certifications reflect our unwavering commitment to global pharmaceutical quality benchmarks.

WHO-GMP
Since 2001

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.

ISO 9001:2015
Certified 2008

Quality Management System

ISO 9001:2015 certification validates our systematic approach to quality management, continuous improvement, and customer satisfaction.

ISO 14001
Certified 2015

Environmental Management System

We are committed to sustainable manufacturing practices, minimising environmental impact across all our production facilities.

GMP EU
Certified 2018

European Union GMP Compliance

Our facilities comply with EU GMP directives, enabling export of pharmaceutical products to European markets.

CDSCO
Ongoing

Central Drugs Standard Control Organisation

All our products are registered and approved by India's CDSCO, ensuring full regulatory compliance within the domestic market.

USFDA Compliant
Aligned 2020

US Food & Drug Administration Standards

Our quality systems and documentation practices are aligned with USFDA requirements, supporting our global expansion strategy.

Shomam Pharma manufacturing floor
Our Facilities

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.

Solid Dosage Block500M tablets/year

Dedicated production lines for tablets and capsules with automated granulation, compression, coating, and blister packaging. Capacity: 500 million tablets/year.

Liquid & Syrup Block10M litres/year

Fully enclosed liquid manufacturing suites with automated filling and sealing lines for oral liquids, syrups, and suspensions.

Injectable Suite50M vials/year

Class 100 (ISO 5) cleanroom environment for sterile injectable manufacturing, including lyophilisation and aseptic filling capabilities.

Quality Control Laboratory24/7 Testing

Fully equipped QC lab with HPLC, GC, UV-Vis spectrophotometry, dissolution testing, and microbiology suites for in-process and finished product testing.

Manufacturing Process

From Raw Material to Patient — Every Step Controlled

01

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.

02

In-Process Quality Control

Dedicated IPQC teams monitor critical process parameters at every stage — granulation, compression, coating, and filling — ensuring batch consistency and compliance.

03

Finished Product Testing

Each batch undergoes comprehensive testing including assay, dissolution, uniformity of content, microbial limits, and stability studies before release.

04

Packaging & Labelling

Automated packaging lines with vision inspection systems ensure correct labelling, tamper-evident sealing, and serialisation for traceability.

05

Stability Studies

Long-term and accelerated stability studies are conducted under ICH guidelines to validate shelf life and storage conditions for every product.

06

Dispatch & Cold Chain

Temperature-controlled warehousing and GDP-compliant logistics ensure product integrity from our facility to the end customer, anywhere in the world.

Supply Chain

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.