Lucent Biotech

Manufacturing

Overview

niche marketing

We ere the pioneers in initiating the idea of niche marketing and today, rank amongst the best in the therapeutic segments of Neurology, Physiatry and Pain Mangement with a significant presence in Gastro-Intestinal and Anti-Infective segments.

We blazed a new trail by successfully implementing the concept of niche marketing.

Lucent Biotech Limited also has a reliable third-party manufacturing business spread across whole India with top Multinational and top pharmaceutical companies getting products manufactured through us. The Company also operates its marketing division all across India.

We have ensured world-class quality in design, equipment and operations in all our manufacturing facility in Roorkee, Uttarakhand.

+ 0 %
Efficiency
- 0 %
cost reduction
- 0 %
Bio waste

manufacturing

wealth of experience

Our manufacturing operations are focused on producing generics, branded generics, speciality, over-the-counter (OTC) products in the full range of dosage forms, including tablets, capsules and liquids.

We have a highly skilled team of Production, Quality Control and Quality Assurance specialists who are well versed with Quality policies and procedures. They have a wealth of experience in the timely delivery of Product as well as handling critical product.

quality design, equipment and operations

A wide range of regulatory agencies routinely conduct stringent audits of our manufacturing facilities for compliance with Current Good Manufacturing Practices (cGMP). Several agencies, including Intas Pharmaceuticals, Zydus Cadila, Micro Labs, Morepen Laboratories, Galpha Labs and many more.

Our site is located at distance of about 72Km from Dehradun and approx 15 Km away from Roorkee railway station. The plant is located at Puhana lqbalpur road near RIT College. The site is free from any toxic or obnoxious gases or other pollutants from neighboring industries. Company is surrounded by South side one pharma formulation unit is situated. On North & West Side by vacant land and in East side (Front side) by National Highway (NH344).

Our manufacturing facilities include

Raw and Packing material Warehouse, Finished Goods Warehouse, section for the manufacture of Tablets and Capsules preparation

Appropriate HVAC systems are provided to cater to the proposed facility with proper segregation to meet the required environmental classifications and pressure gradients

All Process equipment shall be new, carefully sized for optimized functioning. Provision for octagonal blender is provided in granulation Section.

Sophisticated quality control lab is provided. All the testing of raw, intermediate and finished goods is done in-house and outside govt. approved Testing Laboratory at Delhi & Roorkee

The other utilities such as Air-compressor etc will be generated and distributed for the facility as required. Separate utility block with all provisions for DG set, Air handling units and other equipment substation

The unit has adequate potable water resource and an exclusive ETP plant and obtained Pollution Control clearance

Change Rooms and changing Philosophy is strictly in accordance with international cGMP standardsExclusive canteen for the factory is provided

Packing facilities includes Blister Packing Machine, Strip packing machine and Alu-Alu packing machine

R&D center

Research & Development

As per our long term business model and strategy we are looking to setup an advance R&D center for developing generics and technologically complex products. To develop Our core strength lies in our ability to excel in through focused teams in formulations, process chemistry and analytical development. Developing an expertise in developing generics, difficult to make technology intensive products, Active Pharmaceutical Ingredients (APIs), Novel Drug Delivery Systems (NDDS) and New Chemical Entities (NCEs).

Quality Control

Serving Patients first is our motto

It is the policy of the company to manufacture & supply products conforming to National & International standard to the customer & buyer. Our motto is to assure ‘Zero Defects’ products through building quality into the product rather than inspecting defects out of our product.

We ensure that every product manufactured and distributed  complies with all safe practices and standards of quality, purity, efficacy and safety.

To maintain quality standards, Our facility has well defined procedures and systems in place in compliance with the requirements of the Current Good Manufacturing Practices (cGMP) and aim to achieve WHO-GMP certification soon.

Our site has well trained professionals for quality control along with a quality assurance department ensuring strict adherence to quality systems and procedures. The teams are guided by a Corporate Quality Unit (CQU). The team also ensures that the latest updates in GMP are being translated into guidelines, standard operating procedures (SOPs) and protocols. The teams ensure that these guidelines are implemented to deliver quality products time after time.

Our commitment to quality goes beyond ourselves and business. We insist that our business partners comply with all the regulatory compliance and business standards which are in alignment with those of our own. Our own quality standards and procedures are constantly benchmarked against global best practices.

best-in-class technology and processes

For us customer satisfaction is our prime objective. To achieve these objectives we shall evolve and maintain efficient Quality Management System. The Management is fully committed to implement this quality policy in the company and upgrade & improve quality of our products as well as working.

Quality is considered paramount at our locations where we conduct regulated research, development, manufacture, testing and distribution of pharmaceutical products. Our operations are driven by best-in-class technology and processes, abiding by all major stringent GMP approvals. Implementation of robust global quality management system is based on our determination to sustain a culture of operational excellence, meeting and exceeding the expectations of all Investors, including patients, customers and regulators. Thus, our passion for quality goes beyond business.

We are committed to the highest levels of quality and assurance of our products and will ensure that all our facilities, offices and legal entities continue to meet the exemplary standards that are expected of a global pharmaceutical company

The functions of Quality Assuarance Department

Ensure that the medicinal products are designed, developed, manufactured and tested in a way that take account of the requirements of oGMP and GLP regulations.

Release Finished Products, Prepare and review QA SOPs, Review Validation Protocols, Conduct Self-inspection and report on the same to higher management on corrective actions

Handle Market complaints and investigate & Handle Product Recall, Handle Change Control Procedure and deviation, Perform Vendor Audits and evaluate vendor on basis of established vendor selection criteria

Issue copy of blank Batch Manufacturing Record from the corresponding approved masters and review completed Batch Manufacturing Record.

Perform Annual Product Quality Review, Coordinate training programs, Stability monitoring

Review and release of documents for registration, Issue QA documents, review & archive documents of other departments