Medilux Brochure Presentation - First Cut

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OUR STORY

Medilux Laboratories has been providing quality back-end support to the Pharmaceutical industry since our inception in 1988. Our resources are dedicated to promoting better health through superior-value products.

Located at Pithampur, Madhya Pradesh, Medilux Laboratories has been committed to strategic research, delivering a complex range of globally benchmarked chemistries. Our products and services are rapidly making strides in the global pharmaceutical space, giving us the impetus to strive for excellence and provide quality customer service constantly. Our absolute delight is in developing pharmaceutical products that add value and bring joy to our customers and society in general.

CEO’S DESK

“Good” is undoubtedly good but being good is just a starting point. In pursuit of excellence, GOOD is never sufficient; only GREAT would be the next destination.

Always working to create a “Good-to-Great” culture, team Medilux is remembered with reverence for their achievements in the field of chemistry. Always looking for a better way of doing things, they seek new, innovative opportunities to excel, overcome adversity, and provide alternative, constructive views.

Medilux has great respect for knowledge and encourages the talented workforce in its organisation. Deserving employees are in good positions and contribute remarkably to achieving the organisation’s goals. All those joining our Medilux family are taught morals and ethics and then trained to execute their jobs with responsibility.

Furthermore, with a customer-centric approach, we are small enough to care and big enough to deliver. We are responsive, dependable, and empathetic in advocating customers’ needs, goals, and objectives.

Contribution to society is our duty. At Medilux, we believe in this moral responsibility to provide, through various schemes, a better living for the people deprived of even the basic amenities.

Deepak Kewalramani

FROM THE
OUR JOURNEY 1995 2019 2016 1993 2019 2016 1991 2018 2015 1988 2017 2014 Founded in the year 1986, the company came into production in the year 1988 EUGMP Audit & Approval Commencement of GMP warehouse. Acquired by the current management. The capacity being 4000 liters USFDA-Reinspection and Approval WHO-GMP approval Enhanced capacity to 15000 liters PMDA Audit and Approval USFDA Audit & Approval Visited CPHI Frankfurt to acquire overseas business Commencement of production in Plant 4 Commencement of production in Plant 3
199920022003-2005 2021 1997 2021 Contract manufacturing based on chlorination from USA customer WHO-GMP Re-inspection and Approval. Acquired GMP certification from local FDA Expansion of capacity by further 20000 liters Commencement of production in Plant 5 Acquired ISO-9001, ISO-140001 Medilux becomes 100% EOU Enter in to the market of JAPAN Major expansion increasing capacity to 60000 liters Commencement of production in the PLANT 2 for API 2012 2009 2007-20082006
Medilux owes its success to its dynamic management team that has the right combination of experience and young talent. They are supported by the right team members and are poised to achieve greater heights in coming years.
CEO & Managing Director MANAGEMENT THE
ROMI DAIYA Executive Director Director R&D GM-Sales
DR. RITESH
MISHRA RAJ
DARGAR MONICA TRIPATHI Head - QCHead – ProductionVP-RA&QA
To become a World-Class Process based Research & Development Manufacturing company To become a Globally Recognized Player in the Custom & Contract Synthesis Space VISION MISSION
At Medilux, we possess a state-of-the-art facility that meets international standards and adheres to safety and environmental norms. It is located at Pithampur, Madhya Pradesh, in India. We have four manufacturing blocks for the following activities • Block 1: Intermediates • Block 2: APIs • Block 3: Intermediates • Block 4: Niche & High Value, Low Volume APIs OUR INFRASTRUCTURE The infrastructure consists of: • Utilize specifically designed equipment to handle the demanding chemistry requirements • Ensure that reactions are monitored by trained and specialized professionals that cater to pilot to commercial projects. Our team of dedicated professionals possesses the required expertise and transfer knowledge during a scale-up • Conduct routine training sessions to keep our members regularly updated on the various regulatory requirements that govern all the disciplines
• Possess State-of-the-Art stainless steel and glass-lined reactors ranging from 200-6,300 litres with a capacity of 100m3. Other essential features of these reactors include : • (-)40°C to 210°C temperature range • Vacuum of 0.5mm Hg • High pressure and temperature reactions • Multi-stage synthesis • Scale-up of intermediates and final compounds Our various departmental facilities include: • Synthetic / Process Development lab • High-Pressure Reaction Facility • Fully equipped Analytical Development Lab • An excellent Milligram (mg) to Kilogram (kg) Bench Scale facility • Deploy Stainless Steel and Rubber Lined Centrifuges • Deploy quality Tray Dryers and Rotocone Vacuum Dryer, ANFD, Vacuum Tray Dryers, Conical Mixer Dryer • Deploy short path Distillation of capacity 30 litres/ hour
R & D At Medilux, we have a state-of-art R&D facility of international standards and the following activities are done in the same: • Process development, route selection and optimization • Safety/Hazard assessment • Stability Studies • Cleaning Validation • Comprehensive regulatory support • Process scale-up and validation • Method development and validation
ACCREDITATIONS 35174/17/S MEDILUX LABORATORIES PVT. LTD. PLOT NO. 98-99, SECTOR -1, INDUSTRIAL AREA, PITHAMPUR 454775, DISST. DHAR, MADHYA PRADESH, INDIA PLOT NO. 98-99, SECTOR -1, INDUSTRIAL AREA, PITHAMPUR 454775, DISST. DHAR, MADHYA PRADESH, INDIA ISO 9001:2015 DEVELOPMENT, MANUFACTURE AND MARKETING OF BULK DRUGS, ACTIVE PHARMACEUTICAL INGREDIENTS, INTERMEDIATES OF BULK DRUGS AND FINE CHEMICALS BY CHEMICAL SYNTHESIS PROCESS. For information concerning validity of the certificate, you can visit the site www.rina.org CERTIF CATE No IT IS HEREBY CERTIFIED THAT THE QUALITY MANAGEMENT SYSTEM OF FOR THE FOLLOWING FIELD(S) OF ACTIVITIES IN THE FOLLOWING OPERATIONAL UNITS The validity this certificate dependent on an annual six monthly audit and on complete review, every three years, the management system IS IN COMPLIANCE WITH THE STANDARD IAF:12 IAF:13 IAF:29 The use and validity of this certificate are subject compliance with the RINA document Rules for the certification of Quality Management Systems DEVELOPMENT, MANUFACTURE AND MARKETING OF BULK DRUGS, ACTIVE PHARMACEUTICAL INGREDIENTS, INTERMEDIATES OF BULK DRUGS AND FINE CHEMICALS BY CHEMICAL SYNTHESIS PROCESS. CISQ the Italian Federation of management system Certification Bodies Previous certification cycle expiry date 22/11/2020 and renewal audit ended on 03/11/2020 Reference to be made to the relevant documented information for the requirements of the standard that cannot be applied to the Organization's management system scope RINA Services S.p.A. Via Corsica 12 16128 Genova Italy 23.05.2017 15.02.2021 22.05.2023 15.02.2021 First Issue Revision date Expiry Date Renewal decision date India Certification Head Ram Prasad Vodela Signatory of EA, IAF and ILAC Mutual Recognition Agreements SGQ N° 002 A OHS-4453 MEDILUX LABORATORIES PVT. LTD. PLOT NO. 98-99, SECTOR -1, INDUSTRIAL AREA, PITHAMPUR 454775, DIST. DHAR, MADHYA PRADESH, INDIA PLOT NO. 98-99, SECTOR -1, INDUSTRIAL AREA, PITHAMPUR 454775, DIST. DHAR, MADHYA PRADESH, INDIA ISO 45001:2018 DEVELOPMENT, MANUFACTURE AND MARKETING OF BULK DRUGS, ACTIVE PHARMACEUTICAL INGREDIENTS, INTERMEDIATES OF BULK DRUGS AND FINE CHEMICALS BY CHEMICAL SYNTHESIS PROCESS. DEVELOPMENT, MANUFACTURE AND MARKETING OF BULK DRUGS, ACTIVE PHARMACEUTICAL INGREDIENTS, INTERMEDIATES OF BULK DRUGS AND FINE CHEMICALS BY CHEMICAL SYNTHESIS PROCESS. For information concerning validity of the certificate, you can visit the site www.rina.org CERTIFICATE No. The validity of this certificate dependent on an annual six monthly audit and on complete review, every three years, of the management system IAF:12 IAF:13 IAF:29 The use and validity this certificate are subject to compliance with the RINA document: Rules for the Certification of Occupational Health and Safety Management Systems CISQ is the Italian Federation of management system Certification Bodies RINA Services S.p.A. Via Corsica 12 16128 Genova Italy 22.08.2021First Issue Expiry Date 21.08.2024 Revision date 22.08.2021 Ram Prasad Vodela India Certification Head IT IS HEREBY CERTIFIED THAT THE OCCUPATIONAL HEALTH AND SAFETY MANAGEMENT SYSTEM OF IN THE FOLLOWING OPERATIONAL UNITS IS IN COMPLIANCE WITH THE STANDARD FOR THE FOLLOWING FIELD(S) OF ACTIVITIES Medilux Laboratories has always focussed on quality and processes. Through our various initiatives over the years, we have received the following certifications and accreditations from various global authorities. • USFDA • EU-GMP • ISO 14001 • ISO 9001 • ISO 45001 • WHO-GMP • PMDA-JAPAN

QUALITY

Adherence to Quality

One of the essential prerequisites for an organization to succeed is the quality of products manufactured and services rendered regularly, even when faced with daunting challenges.

Customer expectations have increased, and therefore there is an increasing need to meet these stringent demands. In keeping pace with this growing trend, organizations across the globe continually strive to improve product and service standards with a specific focus on quality. This regard for quality forms the crux of any organization to achieve the desired level of economic gain.

Quality Management System:

At Medilux, we are committed to the following:

• Ensuring that customer’s future and present needs are met

• Providing quality products and services with zero defects to customers, thereby meeting their expectations.

• Adhering to the ‘quality’ policy and enforcing it throughout the organization

• Ensuring a fully-trained workforce with knowledgeable insights when performing tasks

• Investing in upgrading technological capabilities and methods, encouraging employees to share their ideas towards continually improving the organization’s performance

• Engaging with customers in determining their desired needs before manufacturing products, thereby improving manufacturability and ensuring cost-effective products

• Ensuring suppliers are instructed with clear and precise specifications, thereby ensuring that excellence is maintained; forming solid partnerships in aspiring for a common goal: quality excellence

• Demarcating the departments of Quality Control and Quality Assurance as independent entities from production activity, ensuring separate reports are submitted to the Technical Director

• Assuring that the Quality Control department performs testing according to laid-down specifications, the results of which are then reported to the various production units

• Ensuring that the Quality assurance department adheres to the system and lays down processes that adhere to predetermined norms

• Assuring that the various processing activities, systems, documentation and other specific parameters that determine product quality are within defined specifications and followed stringently

At Medilux, we pride ourselves on ensuring excellent process development and route optimization, which forms an integral part of our business operations. Process enhancements include throughput, yields, safety, robustness, environmental scalability, impact, and cost.

The main reason behind our success lies in the fact that we possess a dedicated staff of professional process chemists that are skilled and adept at meeting the challenges posed by process bottlenecks, solving them and ensuring process improvements.

CAPABILITIES Acetylation Condensation & Cyclization Esterification Epoxidation Friedel Crafts Achiral Synthesis Cyanation Dealkylation DeCarboxylation Dehalogenation Beckmann Rearrangement Acylation & Alkylation Chiral Synthesis Fries Rearrangement Gabriel Synthesis Chloro sulfonation We enlist some of our chemistries that are renowned the world over:
Halogenation Nitration Tosylation Oxidation Phosphorylation Heterocyclic Synthesis Hoffmann Reduction Knoevenagel Michael Reaction Pyridine Reaction Reductive Amination Sandmeyer Reaction Mannich Reaction Reduction (catalytic and chemical methods) Methylation with DMS & Methyl Halide Diazotization Amidation & Amination

EHS

A responsible corporate citizen

At Medilux, we have a comprehensive EHS policy that helps maintain a harmonious balance with the environment, making us an environmentally conscious organization.

We have also set up an elaborate and internationally benchmarked Waste Management system accessible by all sources. Our team of specialized professionals are constantly trained and updated to meet the stringent guidelines and requirements of Environment Control Agencies.

It is safe to say that at Medilux, our teams of professionals are committed to working tirelessly to minimize emissions and maintain the carbon balance of all its partners to promote the concept of a clean and green working process.

In keeping with our commitment, our manufacturing process involves using various chemicals, reagents and process technology and equipment. One of our main policies reassures our employees that we will take all necessary precautions required to ensure that the workplace is free from fatal accidents, injuries and exposure to hazardous chemical substances.

Our Environmental objectives help us:

• Comply with all relevant environmental legislations and standards that ensure occupational health and safety

• Ensure a safe and healthy working environment by providing the requisite infrastructure and systems

• Implement only the best process safety and management techniques, which include safety audits, analysis, operability studies and safety-related information documentation, to decrease EHS’s association with our operations

• Impart the requisite training to all our employees

• Communicate the EHS policy to all our contractors and vendors to ensure their compliance

• Review constantly the objectives and set targets to enhance

EHS performance

• Prevent the onslaught of pollution and optimize resource utilization through the method of process improvements and R&D activities

• Integrate the EHS policy into Business Planning and decision-making process

• Monitor EHS implementation regularly to ensure adherence

Note: The EHS policy will be implemented, monitored and reviewed regularly to ensure compliance. The policy will also be communicated to all the stakeholders.

We are also committed to protecting the environment by preventing pollution and conserving natural resources.

CLIENTS

We are proud to be associated with some of the best companies globally. A few of them have been mentioned below:

OUR

GLOBAL FOOTPRINTS

We have successfully executed projects with clients from various countries such as:

ASIA

EUROPE

USA

Korea

Croatia Argentina Finland France Germany Greece Italy Belgium Spain Poland Portugal

Nepal Thailand Indonesia Pakistan Bangladesh Japan South
China Iran Isreal Lebanon Saudi Arabia Egypt Turkey AMERICA Brazil Canada
AUSTRALIA
Uk Austria
Switzerland
Plant : Plot No. 98-99, Sector-1, Industrial Area, Pithampur - 454775, Dist. Dhar, Madhya Pradesh, India. Tel: +91-7292-409 991 / 409 992 / 409 993 Email: info@medilux.co.in Sales: Tel: +91-7292-409 991 / 409 992 / 409 993 / +91-9819 666 688 Email: marketing@medilux.co.in, romi@medilux.co.in CONTACT US www.Medilux.co.in Scan the QR code to view website

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