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.
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
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.
At Lupin, we continue to invest in our manufacturing facilities to enhance the efficiency and effectiveness of our processes.
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:
With the first phase ongoing at our Goa and Tarapur sites, the program will cover our Nagpur and other sites in the coming years.
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 | |
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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. |
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:
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.
Plant | Description | EHS | Regulatory Approvals | Capacity |
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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 |
Plant | Dosage | Description | Regulatory Approvals | Capacity |
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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 |
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