“Embedded in Lupin is a formula for growth which fuels creativity, performance and innovation”
It was Dr. Desh Bandhu Gupta’s vision and passion which helped him grow a small dream into a large company with a global footprint.
The most advanced pharmaceutical product development
Developing new chemical entities for focused therapy areas
Producing quality medicines in areas of unmet needs
Producing high quality affordable and accessible biologics
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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.
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.
- 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.
- 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.
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 Plant operation started in 1979. This is the first plant of Lupin with various dosage forms like Tablets, Capsules and Liquids.
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Year of foundation: 1979
Address: A/28/1, MIDC Industrial Area, Chikalthana, Aurangabad - 431 210
No. of Plants: 1
Nature of business: Manufacturing of tablets, capsules and liquids
Size of the facility: 60000 sqm
Approvals: WHO / US FDA / MCC / TGA / ANVISA / German
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.
Year of foundation: 1982
Address: Lupin Limited, Plot No. 09,123,123/1,124 & 125, GIDC Estate, Ankleshwar 393002 (Gujarat)
No. of Plants: 11
Nature of business: Manufacturing Intermediates and Bulk drugs
Size of the facility: 40 acres
Employees: 984
Approvals: FDA / CCA/ WHO GMP / KFDA / ISO 14001:2004 / OSHAS 18001:2007 / MHRA / WHO Geneva / ANVISA / EDQM / ISRS
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.
Year of foundation: 1986
Address:198-202, New Industrial Area No. 2, Mandideep, Dist. Raisen 462046, M.P
No. of Plants: 9
Nature of business: Manufacturing of APIs (Cephalosporins & Cardiovascular) and Formulations
Size of the facility: 58 acres
Employees: 1278
Approvals: US FDA / UK MHRA / AFSSAPS-France / TGA-Australia / WHO
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.
Year of Foundation: 1992
Address: T-142, MIDC, Tarapur, Boisar (West), Dist. Thane, Maharashtra 401506
No. of Plants: 16 Manufacturing Plants and 5 Solvent Recovery blocks
Nature of business: Manufacturing of “Active Pharma Ingredient” (Fermentation based and synthetic)
Size of the facility:2,17,744 Sqm (built-up area is 95,628 sqm.)
Employees: 1221
Approvals: US FDA / MHRA / WHO (Geneva) / KFDA / COFEPRIS / PMDA
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:
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
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.
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. The Temperature in winter goes to Min- 1-3 Deg C and 46-47 Deg C during Summers. Dogri, Hindi, Punjabi, Kashmiri, Urdu are the common languages spoken in the area. Jammu is well connected by train, road and air. Delhi is 600 Kms. and Srinagar (Summer Capital of J&K) 300 Kms. from Jammu.
Year of foundation: March 2006
Plant Address: EPIP Kartholi, SIDCO Industrial complex, Bari Brahmana Dist. Samba, Jammu & Kashmir 181133
Nature of business: Formulations
Size of the facility: 59 Kanals (7.36 acres)
Employees: 219
Approvals: WHO Geneva ,Ukraine MOH, CDSCO (INDIA) approval as per WHO guidelines.
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.
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. It has well equipped and multi range facilities to deliver the products in the range of developmental quantity to commercial scale. Facilities are well designed and qualified to meet the cGMP requirement and having a competent workforce for the need. It is also backed up with onsite R&D center. Site is emerging as one of the facility for manufacturing APIs for advance markets.
Year of foundation: 2007 (Acquired from Rubamin Pharmaceuticals).
Address: Block 21, Village Dabhasa, Ta-Padra Vadodara 391440
No. of Plants: 6
Nature of business: Intermediates and API Manufacturing
Size of the facility: 30 acres
Employees: 285
Approvals: ISO-9001 / ISO-14001 / OHSAS-18001 / WHO cGMP
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.
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. This is the only site of Lupin having capability to manufacture various finished dosage forms like Tablets, Capsules, Ophthalmics, Dermatological Preparations, Metered Dose Inhalers (MDI), Dry Powder Inhalers (DPI) as well as Active Pharmaceutical Ingredients (API). This Facility has been inspected by US FDA, UK MHRA, Germany BfArM and WHO. This site has got honor to become the first site certified by SA 8000. As on date this site supplies to regulated markets of USA, UK, France, Germany, Australia and Canada.This site has 3 sub units, where :
Unit-1 is having dedicated plants for manufacturing of Oral Formulations and Active Pharmaceutical Ingredients (API) (Manufacturing capacity - 1 Billion Tablet/Capsules and 30 to 140 Kg API).
Unit-2 is having dedicated plants for manufacturing of Oral Formulations and Sterile Ophthalmics (Manufacturing capacity - 10 Billion Tablet/Capsules and 6 Million Ophthalmics).
Unit-3 is having dedicated modules for Manufacturing of Dermatological, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Formulations (Manufacturing capacity – Derm-6 Million units, MDI-3 Million units, DPI – 178 Million units).
Year of foundation: Plot No.2 - Unit 1&2 - November 2007 | Plot No.M1- Unit 3 - October 2010
Address Unit 1&2:
Plot No. 2, Special Economic Zone Phase – II, Miscellaneous Zone, Apparel Park, Pithampur, Dist.- Dhar, MP- 454 775, INDIA
Address Unit 3:
Plot No. M1, Special Economic Zone Phase – II, Miscellaneous Zone, Apparel Park, Pithampur, Dist.- Dhar, MP- 454 775, INDIA
No. of Plants: 7 (4 Formulation + 3 API)
Nature of business: Manufacturing of Formulations and Active Pharmaceutical Ingredients (APIs)
Size of the facility : Plot No.2 (Unit 1&2): 107965 sqm | Plot No.M1 (Unit 3): 50039 sqm
Total Employees: 1345
Approvals: US FDA / UK MHRA / Germany BfArM / WHO / SA 8000
Lupin's latest formulation facility is located in Special Economic Zone, SEZ, Nagpur, MS, Central part of India.
Lupin's latest formulation facility is located in Special Economic Zone, SEZ, Nagpur, MS, Central part of India. Dedicated facility for manufacturing of solid oral dosage forms.
Manufacturing capacity: Existing block is designed for exhibit batches for USA, EU, WHO & ROW Market
Address: Plot 6A, Sector 17, SEZ, MIHAN Notified area, Nagpur, Maharashtra, India 441108
No of plants: 01 EB
Plant inception: Aug 2013
Nature of business: Manufacturing of formulations
Size of the facility: 60703 Sq M
Employees: 208
Approvals: Approved by WHO, USFDA
Located in Plot No.130, Road No.11, J.N.Pharma City, Parawada (M), Visakhapatnam, Andhra
Plant Operations started in: January 2016
Year of Foundation: 2014
Address: Plot No.130, Road No.11, J.N.Pharma City, Parawada (M), Visakhapatnam, Andhra Pradesh , India – 531019
No.of Plants: 2 Blocks comprising 4 independent manufacturing streams.
Nature of business: API Manufacturing
Size of the facility: 27.71 Ac
No.of employees: 150
Approvals: Drug Control Authority, Govt.of A.P
4th Mile, Bhasmey, Karmarey-Bhasmey Block, Duga Iilaka, East Sikkim, Sikkim- 737132 India.
Plant Operations started in: 2015
Year of Foundation: 2015
Address: 4th Mile, Bhasmey, Karmarey-Bhasmey Block, Duga Iilaka, East Sikkim, Sikkim- 737132 India.
No.of Plants: One Block
Nature of business: Manufacturing - Formulation
Size of the facility: Total Area 28779.92 sq. meter & Built up Area – 11513 sq. meter
No.of employees: 180
Approvals: Local FDA ( Manufacturing & Sales)