Global Manufacturing Supply Chain

Five decades of quality-driven and customer-centric manufacturing

Lupin’s prowess in meeting unmet customer needs while bolstering a promising future, stem from its 15 state-of-the-art manufacturing facilities spread across India, United States, Brazil and Mexico. Operational rigor coupled with strong regulatory compliance serves as a sound foundation for Lupin to deliver affordable and superior quality products worldwide.

Lupin's global manufacturing philosophy is strategic yet simple: drive continuous improvement and innovation, eliminate inefficiencies, facilitate teamwork and problem solving, and encourage lean manufacturing.

Lupin’s sustained growth and leadership as a global formulation and API major is a direct outcome of our unrelenting focus on competent manufacturing. Our facilities are inspected and audited regularly as a standard practice as per cGMP guidelines as laid down by leading regulatory authorities.

They are also well-aligned with world-class practices that ensure that inputs reach our plants and our products reach customers ‘on-demand’ and ‘in-time’ across the world.

As per global manufacturing norms, all pharmaceutical facilities are periodically inspected and audited by regulatory authorities like the US FDA, World Health Organization (WHO), MHRA (UK), TGA (Australia), MHLW (Japan), ANVISA (Brazil) and MCC (South Africa), among others. Lupin’s manufacturing facilities are also inspected as a standard practice. Our operations, supply chain and procurement processes are aligned with global commercial plan and protocols. This helps to ensure a smooth transfer of inputs into our plants and timely output of products to worldwide customers.

Our global supply chain has been instrumental in making us the preferred suppliers amongst customers. The key metrics of deliverance like OTIF (On Time in Full) has remained above 95% in the majority of the markets. The model has always been found to be robust with accolades from multiple channel partners. We carry out periodic 'supply risk assessments' to absorb supply shocks. We value our customers deeply and have placed stringent procurement processes in order to be competitive and serve them on-time. In order to minimize supply dependency, de-risking projects are routinely undertaken for seamless supply and cost optimization.

QUALITY

The importance of quality cannot be undermined in any organization. The customers both in India and overseas are becoming increasingly demanding with respect to cost, quality and delivery performance. Achieving these three require imbibing the philosophy of 'Total Quality Management' into the organization's culture. At Lupin, it is the very essence of our operations.

At Lupin, we take pride in maintaining superior quality at every stage of our processes. That we ensure and assure. Our operations are guided by our Quality Policy. We believe that quality is the backbone of competitiveness. Thus, we constantly create an environment of Quality and Compliance in line with the global best practices.

Quality Assurance is defined as the process of 'providing confidence that requirements will be met through highest quality' and thereafter systematic activities are put in place to ensure quality requirements for a product or service are fulfilled.

The Corporate Quality Assurance (CQA) cell at Lupin works as a link between research & manufacturing for quality products for customers. It targets at ensuring that the Lupin Group follows a standardized common quality system ensuring consistency, effectiveness and efficiency while manufacturing APIs and formulations at all sites. The Company now has a host of drug delivery platforms that have already been developed.

THE CQA FOCUSES ON:

- Establishing Quality Standards

- Developing processes to achieve those standards

- Monitoring to ensure Compliance

- Upgrading technology standards

- Training personnel on quality aspects

Lupin global quality team is engaged in driving the quality philosophy of the organization and assuring that the global standards of good manufacturing are implemented in the best form and spirit at every location during each process.

CQA monitors the effectiveness of Site Quality organization and Contract Manufacturing Quality organization through periodic quality reviews, periodic audits, budgetary reviews and review of compliance to regulatory inspections and customer audits. Quality reviews focus on review of failures, rejections, market complaints, deviations, non-compliances, product stability, various Corrective and Preventive actions planned, productivity, cost of quality etc. CQA also supports the site Quality organization by providing necessary resources, technical guidance and training. CQA endeavour to upgrade skills and competence levels in QC / QA function by introducing advanced technologies. Enterprises that exemplify leadership in quality not only deliver quality products and services, but also effectively set industry benchmarks and redefine standards for those who share their mission.

OUR QUALITY POLICY

- The Company shall establish and maintain high standards of quality for its products manufactured at various sites, including those at contract manufacturing sites, meeting cGMP and cGLP norms.

- Products shall be manufactured and marketed meeting all quality parameters related to identity, purity, safety and efficacy through well-defined quality assurance and validated systems.

- The Company shall comply with current national and international regulations as applicable and continuously strive for achieving stringent global standards. Major thrust shall be given on quality upgrade and product integrity on a continuous basis to achieve a higher level of customer satisfaction.

- Continuous training shall be given to the employees in the organization to enhance their skills in performing their assigned tasks.

We believe Quality and Regulatory Compliance not only have to be embedded into the product but must be built into people, systems, and processes through a systematic process of continuous training and knowledge sharing.

The Company today has over 700 Global Corporate Quality Assurance professionals spread across all manufacturing locations engaged in developing and implementing policies that ensure quality and compliance with global regulatory standards. Consistency in meeting customer expectations and meeting regulatory quality and compliance norms are the true enablers and the critical differentiator that has made Lupin the global generic powerhouse it is today.

As Lupin aspires to accelerate and scale higher orbits of growth, we are conscious of the fact that product and market complexity will increase exponentially. We are aware that the Company needs to stay ahead of the curve by continuously investing in new technology, automation and systems to create better efficiencies that enhance profitability. We are also investing prudently in expanding our manufacturing operations by setting up new facilities and plants to meet future demand. We actively engage with leading consulting organizations to build a manufacturing operation second to none and continuously sharpen our compliance ethic.

LOCATION

Lupin's global manufacturing operations are spread across India, USA, Brazil and Mexico. The Company has 15 world-class facilities manufacturing supplying APIs and formulations approved by leading pharmaceutical regulatory authorities like the US FDA, World Health Organisation, MHRA (UK), TGA (Australia), MHLW (Japan), ANVISA (Brazil) and MCC (South Africa). These world-class facilities embody a culture of continuous improvement to deliver complex products with optimum efficiency. With a focus on maintaining the right efficiencies, Lupin has continued on its quest for manufacturing excellence, focusing on cost reduction using principles of six sigma and lean manufacturing.

We believe Quality and Regulatory Compliance not only have to be embedded into the product but have to be built into people, systems, and processes through a systematic process of continuous training and knowledge sharing. The Company today has over 700 Global Corporate Quality Assurance professionals spread across all manufacturing locations engaged in developing and implementing policies that ensure quality and compliance with global regulatory standards. Consistency in meeting customer expectations and meeting regulatory quality and compliance norms are the true enablers and the critical differentiator that has made Lupin the global generic powerhouse it is today.

As we aspire to further accelerate and scale higher orbits of growth, we are conscious of the fact that product and market complexity will increase exponentially. We are aware that the Company needs to stay ahead of the curve by continuously investing in new technology, automation and systems to create better efficiencies that enhance profitability. We are also investing prudently in expanding our manufacturing operations by setting up new facilities and plants to meet future demand.

In an eﬀort to minimize errors arising out of manual interventions, we have embraced technology and automation across all our sites. We have also introduced several automated processes like advanced robotic equipment for preparing analytical samples at our Indore site. There are several other enterprise-wide systems being implemented that will bring Lupin to being best-in-class in both our Manufacturing and Quality operations. These include electronic Batch Production Records, Laboratory Information Management System and a Quality Assurance Management System. We recognize that we also have to continuously upskill our team and have completely overhauled our training program for technical personnel. Measures like Gemba Walkthroughs instituted across our manufacturing facilities ensure continuous assessment and true ownership of our sites by our team.

Through the resilience built into our supply chain and concerted and collaborative eﬀorts with supply partners, the team ensures continuity of production and supply of our products.

AURANGABAD

Aurangabad Plant operation started in 1979. This is the first plant of Lupin with various dosage forms like Tablets, Capsules and Liquids.

ANKLESHWAR

The Company is an ISO 14001:2004 and OSHAS 18001:2007 Company. It has well integrated environment system to treat the effluent water whereby the characteristics are below the norms of Gujarat Pollution Control Board. Manufacturing practices are in compliance to cGMP norms.

MANDIDEEP

This facility is engaged in the manufacturing of APIs as well as dosage forms which produces Sterile and Non-Sterile pharmaceutical products and mainly caters to the US and Europe markets.

TARAPUR

The manufacturing facility for APIs has been started in 1992 and has a state-of-art fermentation facility and synthetic API manufacturing multi product plants. The Facility has been inspected by US FDA, MHRA,WHO, KFDA COFEPRIS and PMDA. It has 100% power back up for the entire facility.

GOA

Goa plant foundation stone Project startup was done in August 2003 and it was built up in record time of only 6 months to start operations in Feb 2004 Pilot scale operations started in March / April 2004 with initiation of Exhibit batches of Lisinopril tablets for US market and EU market.

Goa plant foundation stone Project startup was done in August 2003 and it was built up in record time of only 6 months to start operations in Feb 2004 Pilot scale operations started in March / April 2004 with initiation of Exhibit batches of Lisinopril tablets for US market and EU market. The plant started with a Manpower total strength of only 30 people in 2004. First US & EU Regulatory filing for Lisinopril tablets from Goa was done which made Goa sail through its first USFDA Pre Approval inspection in June 2005 and MHRA inspection in Nov 2005.

Goa plant has been subjected to multiple extensions & plant-02 operational in 2015.Goa plant manufacture and deliver oral dosage forms with a capacity of more than 9 Billion units / Annum. Till date Goa plant has executed more than 350 Exhibit Products for US, EU, AU, Japan &Brazil markets. It has been inspected by USFDA six times and MHRA five. It is also inspected by WHO Indian agency four times & by ANVISA once. Commercial supplies to US & EU market were initiated with product Lisinopril tablets in Nov 2005 & Aug 2007 respectively. As on date the plant supplies more than 100 Products to regulated markets of US, EU & AU. Goa plant has filed as on date more than 115 ANDA's in US market, more than 80 filings in EU & AU market,10 ANDA’s for Japan market and 03 ANDA’s for Brazil Market.

Goa plant major production volume supply to US Market with Quality is major objective. High skilled & qualified personnel engaged in manufacturing, packing & quality testing of products in world class facility.

Goa plant having Project Disha-A manufacturing excellence initiative - build a sustainable operating model for improving and sustaining profitability by developing continuous improvement capabilities within Lupin.

Milestones:

Plant Foundation : Aug 2003
Plant Operations Start up : Feb 2004
Exhibit batches start up : April 2004
Commercial batches start up : Nov 2005
SA-8000 certification: July 2015
Winner of the economic times India manufacturing excellence awards in partnership with Frost & Sullivan 2012-Platinum certificate Year 2012
New plant (Plant-02) foundation: Jan 2014
New plant (Plant-02) commercial batches start up: Dec 2015

Year of foundation: 2003

Address: B-15, Phase 1A, Verna Industrial Area, Verna Salcette-Goa 403722

No. of Plants: 02

Nature of business: Formulations – Solid Oral Facility

Size of the facility: 34710.59 sqm

Employees: 757

Approvals: US FDA / MHRA / WHO/ANVISA/PMDA-Japan/TGA

JAMMU

The Plant is located at about 17 Kms. from Jammu city. Jammu is also known as “City of Temples” and Winter Capital of J&K.

VADODARA

This site has state of art in manufacturing wide range of products in various categories like CRAMS, Pharmaceuticals Intermediates and APIs for international as well as domestic sale.

INDORE (PITHAMPUR)

Pithampur site is one of the Lupin’s largest formulations facility located at Indore Special Economic Zone (ISEZ) and is about 30 Km from Indore city. Hindi is the common language spoken in the area and Indore is well connected by Air, Train and Road.