Uni-Pex Pharmaceuticals Pvt. Ltd.

Our Core Quality Operations

Our quality management system works with two separate, self-governing systems, working together to manage the whole production process.

1. Quality Control (QC) — Analytical & Core Laboratory Science

Raw Material Testing

100% of raw materials of Active Pharmaceutical Ingredients (APIs) and excipients are physically and chemically tested upon receipt at our warehouse.

Advanced Laboratory Equipment

Equipped with advanced digital testing equipment such as HPLC (High-Performance Liquid Chromatography) and UPLC (Ultra-Performance Liquid Chromatography) to monitor the exact concentration of molecules and detect trace impurities.

In-Process Check

Running production lines are monitored by active laboratory technicians who perform tablet hardness, thickness, friability and disintegration time at predetermined intervals.

Finished Product Clearance

A complete chemical stability and technical sealing of the last batch is conducted before a shipment is cleared for loading at the loading bay.

2. Quality Assurance (QA) — System Validation & Compliance Control

Validation & Calibration

We have strict control of all equipment validations, facility log details and all analytical testing equipment is validated and calibrated absolutely.

Documentation & Traceability

Each production lot is fully documented and traceable and every stage from raw compound reception to final packaging is fully auditable.

Sterile Environment Enforcement

Maintaining high sterile environment inside our plant through continuous monitoring of environment in clean room (air particle counts, microbial tracking and pressure balancing).

Vendor Audit Programs

Through rigorous qualification and background checks, raw material suppliers are absolutely qualified from day one.

Validated Production Authority

Our Credentials Protect Your Market Distribution Rights

We believe that legal certifications are more than a step in the process, they are the backbone of how we run our everyday business practices.

WHO GMP

WHO-GMP Compliance

Ensures our whole production plant architecture is functioning according to strict World Health Organization safety and anti-contamination protocols, to guarantee absolute formulation security.

WHO GMP

ISO Certification

Ensures complete traceability of the company's activities, meaning that all the operations from the receipt of raw material to the release of the batch is standardized and fully traceable.

WHO GMP

FSSAI Certification

Ensures our operations are in compliance with the domestic food safety standard for the manufacturing of specialized dietary supplements, nutraceuticals and health-related formulations in a safe manner.

Verified Global Supply Footprint

Deploying Certified Formulations Across 5 Main Continents

We have a regulatory cell that systematically clears customs at borders and deals with intricate legal requirements from health authorities across the globe, to keep international trading networks alive.

Asia

Africa

Africa

Latin America

Europe

CIS Countries

USA

South Asia

Middle East

Middle East

We prepare all the technical dossiers in-house and successfully registered 150+ products in the world. Our customs validation log management ensures hassle-free global dispatch with zero paperwork delays.

Our 4 Pillars of Product Security

Total Batch Uniformity

Each production line is closely monitored to ensure that the same chemical stability and therapeutic effect of a medicine are provided whether it is sent to the northernmost part of the country or the southernmos.

Zero Product Recall Risk

Our laboratories detect and address any trace chemical and packaging anomalies, giving you peace of mind that no market complaints or legal liabilities will be present.

Direct Factory Price Protection

Reduce the reliance on third-party laboratories, ensuring optimal profit margins for your business.

Customs-Ready Validation Logs

Each and every bulk shipment departs from our loading bays accompanied by an authentic and verified Certificate of Analysis (CoA) for smooth customs clearance.