Manufacturing Excellence in Action

At Lupin, our manufacturing philosophy is strategic yet simple: we drive continuous improvement and innovation to produce high-quality, affordable medicines, enhancing healthcare in over 100 countries, while ensuring the safety and health of our employees.

With a global footprint of 15 manufacturing sites spread across India, the United States, Brazil and Mexico, our manufacturing operation is at the core of our business, helping us realize our purpose to be an innovation-led, transnational pharmaceutical major. We have world-class manufacturing facilities, state-of-the-art technologies as well as a truly global supply chain, which help us deliver affordable and superior quality products worldwide. In a constantly evolving landscape, our focus is on strengthening our manufacturing competencies while improving efficiency and productivity to ensure that the highest standards of quality are retained.

To comply with the stringent global regulatory requirements governing the pharmaceutical industry, our facilities are periodically inspected and audited by regulatory authorities as well as our customer and third-party consultants. We have also established a robust internal audit mechanism as well as detailed Standard Operating Procedures (SOPs), which are defined under our Quality System to ensure compliance and regulatory adherence. In addition to our internal processes, our manufacturing facilities are aligned with the best global practices to ensure the efficient transfer of inputs into our plants and timely output of products to our customers. All our global facilities remain compliant to applicable Current Good Manufacturing Practice (CGMP) standards.

After an independent and rigorous audit by an external third-party, Lupin received the prestigious International Sustainability Rating System (ISRS), 8th edition certification for four of our critical sites located in Mandideep, Tarapur, Ankleshwar and Dabhasa. Lupin continues to be the only pharmaceutical company in the world to have attained Level 7 certification for three of its facilities. This certification is strong endorsement of the practices that have been adopted with regards to Risk Management, Safety, and Sustainability at our manufacturing sites.

We strive for excellence in our manufacturing operations and we deploy the highest standards of Risk Management, Safety, and Sustainability at our sites. By 2025, we will ensure that we receive the ISRS certification for all our API sites and one of our Formulation sites.

Site Highlights:

New Pyrazinamide API block
at Vizag has been commissioned

Facility in Sikkim has been expanded to augment production capacities

New facility for High Potent products at Indore has been set up

A new state-of-the-art facility for MDI & DPI Inhalation products at Indore has been set up

The project work for the multi-fold expansion of our Biotech Drug Substance facility in Pune has been completed

Achieving Energy Efficiency

We are committed to improving our operational efficiency and are cognizant of our responsibility to reduce our environmental footprint. To optimize our energy consumption, we have deployed waste heat recovery systems in the boilers at our facilities in Ankleshwar, Tarapur and Pithampur. Further, we are exploring opportunities to increase the consumption of cleaner fuels such as agri-waste biomass briquettes, natural gas, and fuel additives to improve the efficiency of combustion in our boilers. The extent of our Greenhouse Gas (GHG) savings realized through these initiatives have been quantified in the section on Natural Capital.

Achieving Energy Efficiency

Embracing Automation

At Lupin, we continue to invest in our manufacturing facilities to enhance the efficiency and effectiveness of our processes.

  • Metal Detectors: To avoid contamination by foreign particles in our APIs, we installed a metal detector in one of our streams at Tarapur. After observing the impact of the installation, 14 such detectors were imported and deployed across other manufacturing streams.
  • Automatic Duct Cleaning Systems: Powder residue in the ducts of fluid bed dryers is a potential source of contamination in Formulation plants. In order to mitigate this risk, we installed automatic duct cleaning systems across our facilities.
  • Auto Storage and Retrieval System: At our facility in Nagpur, we have commissioned an ‘Auto Storage and Retrieval System’ for WIP materials, which ensures a fully automated mechanism with minimum intervention. This has enabled us to derive benefits of efficient storage and retrieval of material in WIP and minimize human error.
  • Automatic Bin Washing System: At our facility in Nagpur, a segregated and centralized ‘Automatic Bin Washing System’ has been installed to handle cleaning of bins and containers. This ensures efficient cleaning of potential contaminants and is a resource efficient method of handling cleaning.
  • 360-Degree Tablet Inspection: In order to achieve our aspirational goal of zero defects in our products, we have deployed digital systems, which provide a holistic 360-degree inspection of tablets manufactured. This artificial intelligence enabled, camera-based system captures defects such as broken tablets, black spots as well as color variations and segregates these to ensure that only the products that meet all quality specifications are released to market. This machine has been installed in one of the packing lines at our plant in Nagpur and will be commercialized for use in other plants as well.

Digitizing for a Future-Ready Shopfloor

While almost every industry in the world has benefited from the adoption of automation and technology, it holds special value to our industry as the possibilities are virtually limitless.

Our digital and analytics transformation journey was launched with Project ADAPT (Accelerated Digital & Analytics Performance Transformation) in early March 2020, with a focus on:

  • Deploying high-potential Digital and Analytics (DNA) use cases across departments
  • Building a digital-native organization with atscale DNA capabilities and effective change management to scale up interventions across the network
  • Driving tangible performance improvement to deliver value

With the first phase ongoing at our Goa and Tarapur sites, the program will cover our Nagpur and other sites in the coming years.

Way forward

Our focus on the Health and Safety of our employees is evidenced in our commitment to a 10% year on year reduction in the Lost Time Injury Frequency Rate (LTIFR), Severity Rate, Accident Frequency Rate, and Incident Frequency Rate, taking FY20 as the base year. We continue to monitor these KPIs and ensure the highest degree of compliance to regulations as well as our stringent internal SOPs to prevent occurrence of unforeseen events.

Reinforcing Biotech
Lupin is actively expanding its manufacturing base to meet global demands for its diverse and complex products. Over the years, we have transitioned from an oral solids heavy portfolio to including much more complex generics such as injectables, biosimilars, and inhalation products. Apart from our 2 X 1000L current mammalian facility, we have additionally commissioned a new 3 X 1000L manufacturing facility in FY21 and have already commenced production of Etanercept Biosimilar in this new facility in FY22. This facility has accreditation from local FDA and will subsequently undergo regulatory inspections by the European Medicines Agency and Japanese PMDA authorities to obtain approval to supply commercial material. Our Biotech site at Pune is also expected to face its first audit from the USFDA in the FY22 for its microbial facility.
Digitizing for a Future-Ready Shopfloor

Unlocking Digital Innovation

We are conscious that Lupin needs to stay ahead of the curve by investing in cutting-edge technologies to create better efficiencies that enhance profitability and provide a competitive edge. We have introduced the following automated processes, which strengthen our systems and minimize errors to produce the highest quality of products:

  • Electronic Batch Process Record (eBPR): The eBPR is a system that stores batch-wise data associated with operators, manufacturing process, equipment, materials, and supplies that are used to manufacture a product. It helps reduce paper consumption as well as improves data integrity and accuracy by streamlining processes and operations. It is currently implemented in our Nagpur plant and will be expanded to our plants in Goa, Pithampur and Aurangabad in the next 2 years.
  • Laboratory Information Management System (LIMS): LIMS improves lab productivity and efficiency by keeping track of data associated with samples, scientific data and experiments. It standardizes and automates workflows, reduces human error, and increases efficiency. The implementation of this system is in progress at our Nagpur plant and the aim is to expand it to all remaining plants across the country in the next 2 years.
  • Central Data Acquisition System (C-DAS): The C-DAS reads the electronic data directly from manufacturing and packaging equipment and stores it in non-editable and tamper- proof software. It ensures the compliance and integrity of the data and reduces the level of human intervention in data management and traceability. This system has been implemented at our Nagpur site, Mandideep API site and Goa sites.

Enhancing Quality

At Lupin, Quality is a way of life that is driven by rigorous discipline, unfailing checks, and unwavering commitment. Our operations are guided by our Quality Policy and we take pride in maintaining and monitoring it at every stage of our processes. We have an established Corporate Quality Assurance (CQA) function, which links our research and manufacturing verticals, ensuring a standardized common quality system and guarantees consistency, effectiveness and efficiency while manufacturing APIs and formulations at all our sites.

Our ‘Quality First’ mandate is a critical regulatory compliance check, which considers every strategic imperative for re-examination and re-evaluation, thereby improving our core manufacturing operations and aligning them with our aspirations. The ‘Quality First’ program constitutes a set of values that act as guidelines to create a culture where we strive to provide the best ‘quality’ output. The purpose of this program is to make an orbital change in our procedures, investigation methods, corrective action plans, training effectiveness, and product robustness.

As a part of the ‘Quality First’ program, the Process Development Lab (PDL) along with the Operational Excellence (OPEX) team has initiated the development of a framework that can evaluate the robustness of our products and provide insights on areas of improvement. This is primarily done to enhance the quality of our products, using the ‘Six Sigma’ methodology. Under this process, we have taken up more than 50 molecules for improvement. The ‘Six Sigma’ process provides Lupin with the tools to improve the capability of our production processes by increasing performance, improving profits, and eventually, boosting the quality of our products. We have successfully completed 28 projects by achieving the desired ‘Six Sigma’ level of quality, and work is in progress to achieve the same level of quality in the other identified projects.

We have also initiated the World Class Labs program, which targets to bring Quality Control in our laboratories to a high Sigma level of quality in invalid Out-of-Specification results as well as laboratory incidents. After a pilot, these solutions are now being cross deployed in all our other labs.

Under this program, A number of process innovations have been identified and implemented, including regrouping of various subsections of our Quality Control laboratories, column performance improvement, communication error reduction by implementing the learnings from OEMs and software upgradation, reduction in inadvertent errors by lab analysts. The program also encompasses reducing movement in the lab through appropriate division of labor and efficient systems which aid in allocating glassware and chemicals, thus allowing analysts to focus on their critical tasks.

We also have a 5S program underway. In the upcoming fiscal, all labs are targeted to be brought to 3S level and upon achievement of this, Lupin will focus on getting them to 5S.

We are aware that our analysts are the key for success of our World Class Labs program. A detailed plan has been developed in partnership with HR focused on fostering learning and training, and implementation of a reward and recognition program for high performing individuals who achieve quality improvement.

Strengthening our systems on quality, is a continuous process. To achieve this, we prepared a Global Quality Action Plan, a holistic approach, which takes into consideration the entire cycle of a quality process, right from recruiting to driving global standardization under a single quality system across all our manufacturing entities.

With over 2,600 professionals in Quality alone, we are constantly engaged in developing and implementing policies that ensure compliance with global regulatory standards. At Lupin, we truly believe that upholding regulatory and compliance norms is the true enabler of superior quality, and acts as a critical differentiator.

Manufacturing capacities

API Manufacturing

Plant Description EHS Regulatory Approvals Capacity
Mandideep
Unit 1
Dedicated Cephalosporin API facility ISRS level-7 for EHS management ANVISA, COFEPRIS, WHO, USFDA, EDQM, TGA, KFDA 1,300MT
Mandideep
Unit 2
Manufacturing site of Cardiovascular ACE Inhibitor APIs ISRS level-7 for EHS management USFDA, TGA, PMDA 200MT
Tarapur Fermentation and Chemical synthesis based multi-product API manufacturing facility ISRS level-7 for EHS management WHO, GMP (India), WHO Geneva, USFDA, CDSCO, USFDA, Russia MOH, PMDA, Japan, ANVISA, COFEPRIS, TGA, MHRA, KFDA 1,449 MT
Vizag Multi-product API manufacturing facility USFDA, WHO Geneva, MFDS Korea, CDSCO 357 MT
Ankleshwar
Unit 1
Dedicated Cephalosporin intermediate and API manufacturing facility ISRS level-7 for EHS management TFDA, KFDA, EDQM, USDMF 1,800 MT
Ankleshwar
Unit 2
High volume API & intermediates manufacturing facility ISRS level-7 for EHS management WHO, EDQM, MHRA, ANVISA, TGA, Ukraine, Russia, IDA China, TFDA 1,400 MT
Dabhasa Multi-product API manufacturing facility ISRS level-6 for EHS management USFDA, TGA, KFDA, Indian FDA 500 MT
Pithampur
Unit 1
High potent, Hormonal APIs Facility USFDA, MHRA, CDSCO, WHO Geneva, Ministry of Industry and Trade of the Russian Federation 1.5 MT
Pune Dedicated Mammalian biosimilars manufacturing facility EMA, PMDA, ANVISA, Taiwan, TGA, Thailand, India 5* 1,000 Litres
Pune Dedicated microbial biosimilars manufacturing facility COFEPRIS, Thailand, India 100 Liters

Formulation Manufacturing Plant

Plant Dosage Description Regulatory Approvals Capacity
Mandideep
Unit 1
OSD Oral solids (tablets/capsules/ dry powder suspension) manufacturing facility for Cephalosporin products ANSM ,USFDA, Russia MOH, CDSCO, Kenya FDA, Philippines FDA, TGA 0.9 billion units
Pithampur
Unit 1
Oral Contraceptives Dedicated Oral solid Contraceptive manufacturing facility. USFDA, MHRA, WHO & CDSCO, WHO Geneva, LAGeSo Berlin (Germany), Ministry of Industry and Trade of the Russian Federation 1 billion units
Pithampur
Unit 1
High Potent Drug High potent oral solid manufacturing facility USFDA, MHRA, WHO & CDSCO, WHO Geneva, LAGeSo Berlin (Germany), Ministry of Industry and Trade of the Russian Federation 1.5 billion units
Pithampur
Unit 2
OSD High volume oral solids (tablets & capsules) manufacturing facility USFDA, MHRA, Berlin Authority, ANVISA Brazil, CDSCO and Indian FDA 4 billion units
Pithampur
Unit 2
Ophthalmic Ophthalmic formulations (Solution, Emulsion and Suspension) manufacturing facility USFDA, MHRA, CDSCO and state FDA 45 million bottles
Pithampur
Unit 3
MDI/DPI High volume Inhalation finished product (MDI/DPI) manufacturing facility USFDA, MHRA 70 million packs/units
Pithampur
Unit 3
Derma Corticosteroids and steroids (Topicals, semisolids) preparations facility USFDA, Accreditation Certificate of foreign Drug Manufacturers from MHLW, Japan 0.35 million packs
Nagpur
Unit 1
(Block 1)
OSD High volume oral solid dosage form (tablets & capsules) manufacturing and packing facility MHRA, TGA, WHO, USFDA, ZAZIBONA, WHO (Geneva), National Drug Authority- Uganda, Republic of the Philippines 100 million units
Nagpur
Unit 1
(Block 2)
OSD Multi product processing facility USFDA & TGA 12 billion units
Nagpur
Unit 2
Injectables Liquid, Lyophilized & Liposomal injections (including Vials, Prefilled syringe & cartridges) manufacturing facility Indian FDA 13 million packs
Goa
Unit 1 and Unit 2
OSD & Oral Suspension High volume oral solids (tablets & capsules) and oral suspensions manufacturing facility USFDA, UK MHRA, WHO, ANVISA, JAPAN-PMDA, KOREA-MFDS. Accreditation Certificate of foreign Drug Manufacturers from MHLW, Japan 6 billion units
Aurangabad OSD High volume oral solids dosage form (tablets/ capsules) manufacturing and packing facility USFDA, WHO, FDA-Taiwan, German 5 billion units
Aurangabad Dry powder Suspension Dry powder Suspension manufacturing facility USFDA 1 million bottles
Jammu OSD Small to medium volumes solid dosage forms (tablets & capsules) manufacturing and packing facility WHO Geneva, Ukraine, Russia 1 billion units
Jammu MDI High volume Inhalation products (MDI) manufacturing and packing facility WHO GMP 5 million packs
Sikkim OSD Small to medium volumes solid dosage forms (tablets and capsules) manufacturing and packing CDSO 1.5 billion units
Sikkim DPI High volume Inhalation products (DPI) manufacturing and packing facility CDSO 600 million units
Pune Injectables Liquid injections including Vials & Prefilled syringes EMA, PMDA, ANVISA, Taiwan, TGA, Thailand, India 1 million units
Somerset,
NJ, USA
Finished dose manufacturing and packaging Potent products, controlled substances, tablets, capsules, powders, liquids and unit dose nasal sprays manufacturing facility USFDA Up to 2.5 billion doses
Brazil Solids Facility High-Volume oral solids (tablets and capsules) manufacturing and packing facility ANVISA, COFEPRIS 3.3 billion units
Brazil Liquids Facility High-Volume liquids (shampoo, syrup, oral drops and suspensions) manufacturing and packing facility ANVISA, COFEPRIS 66 billion bottles
Mexico City,
Mexico
Liquids and Solids Facility Ophthalmic Solutions & Suspensions (Eye Drops), Ophthalmic Ointments (Eye Ointments), Nasals & Solids manufacturing facility COFEPRIS (Mex) & DIGEMID (Peru) on PICS (Pharmaceutical Inspection Cooperation Scheme) & Project plan for EMA & USFDA
  • up to 19.1 Million units of Ophthalmic Eye drops
  • up to 6 Million units of Ophthalmic Ointments
  • up to 10.8 Million Nasal Products
  • up to 50 Million tablets