“We are working towards providing affordable, high-quality APIs”

#SpeakPharma with Metrochem

2023-10-09

Impressions: 3081

This week, SpeakPharma interviews Dr. N.V. Rao, Chairman and Managing Director of Hyderabad (India)-based Metrochem API, one of the fastest growing manufacturers of active pharmaceutical ingredients (APIs), pellets and intermediates. Dr. Rao talks about Metrochem API’s strong core values and how the company has put in special efforts to meet the needs of the under-cared and neglected communities, with a clear view on sustainable health for all.

Can you briefly take us through Metrochem API’s journey?

When we embarked on this extraordinary journey in 2004, armed with my expertise in organic chemistry, our vision was unwaveringly clear. We aimed to establish a company that would manufacture top-tier APIs of exceptional quality, all while maintaining cost-effectiveness. Our goal was to cater to the pharmaceutical industry's global needs and position Metrochem as the premier supplier of APIs to customers worldwide.

Since our inception, we've strongly believed in creating value through vertical integration. This belief has driven us to continuously invest in infrastructure and manpower, ensuring an abundant supply of key starting materials (KSMs), intermediates, and essential raw materials. Our six state of the art manufacturing facilities are designed and operated in line with this risk mitigation vision. We consider ourselves a pure-play API manufacturing company with an acute awareness of the technical challenges facing the healthcare industry.

Our focus has always been on expanding our product portfolio to meet the diverse demands and challenges of the global landscape. We've successfully built a robust product portfolio comprising over 190 products spanning more than 30 distinct therapeutic segments. We excel in handling a variety of niche products that require intricate chemical processes and pose significant challenges, elevating them beyond the typical niche category.

Metrochem's journey, from my perspective, has been a relentless pursuit of excellence, innovation, and a commitment to serving the global pharmaceutical industry with integrity and dedication.

What are some of the key reasons behind Metrochem API’s success?

Our success is credited to our culture, which is founded on innovation, integrity, customer-centricity, and safety. These principles guide every Metrochem team member, and we take immense pride in consistently exceeding expectations.

At Metrochem, our organization's foundation is built upon our core values, which we affectionately refer to as "LEADER." Within this framework, 'L' signifies our dedication to 'Learning aspiration,' 'E' embodies our perpetual pursuit of 'Excellence,' 'A' represents our 'Action-oriented' approach, 'D' symbolizes our commitment to 'Discipline,' 'E' underscores our steadfast dedication to 'Ethics and integrity,' and 'R' stands for 'Respect.'

We maintain a strong commitment to ethical behavior and actively pursue our social responsibilities. We extend respect to every individual, and consider our stakeholders cherished members of our extended family. Building meaningful relationships with our customers, colleagues, and suppliers is an integral part of Metrochem's identity. These values are deeply ingrained within Metrochem, and guide our daily operations.

This robust value system drives our passion for continual growth and self-improvement, both on an individual and at an organizational level. Our enthusiasm is channeled towards achieving operational excellence, with a primary focus on innovation and cost efficiency, all while upholding unwavering quality standards.

How has your manufacturing setup grown over the years? Which regulatory authorities have recognized your efforts?

Our journey began with a single API facility in Hyderabad, accredited with WHO-GMP, where we initially manufactured two APIs. By 2009, this facility had successfully met the rigorous regulatory standards set by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan. In subsequent years, we not only maintained our WHO-GMP accreditation but also earned recognition from the US Food and Drug Administration (FDA) and COFEPRIS (Mexico Health Authority) in 2013. In 2014, we obtained accreditation from the Korea Food and Drug Administration (KFDA), which is now known as the MFDS (Ministry of Food and Drug Safety).

We prioritize adhering to strict regulatory compliance standards. Our commitment is demonstrated through our willingness to undergo regular inspections by esteemed international and national regulatory authorities, including the USFDA, PMDA, WHO-GMP, ANVISA (Brazilian health regulator), and the European Directorate for the Quality of Medicines and Healthcare (EDQM), among other reputable bodies. These recognitions have played a pivotal role in elevating our position as a leading bulk drug manufacturer in India.

We are grateful for the regulatory progress we have achieved over the years. At present, Metrochem has submitted 56 US Drug Master Files (USDMFs), 21 Certificates of Suitability (CEPs), and numerous other significant regulatory filings. Notably, we earned the global top ranking for the number of API USDMFs filed in 2022.

We currently operate with six state-of-the-art manufacturing facilities located in the states of Telangana and Andhra Pradesh, boasting of a total reactor volume exceeding 3000KL. These manufacturing plants are backed by three cutting-edge, centrally located research and development laboratories, along with a pilot plant designated for testing and development purposes.

What are Metrochem API’s target markets? How do you contribute towards sustainable healthcare?

Currently, we are fulfilling pharmaceutical needs across over 60 countries. Unlike the typical focus on developed markets, our dedication extends to addressing healthcare inequalities not only in developed markets but also in the underserved, marginalized communities, and less developed nations. Our overarching vision centers on promoting sustainable access to healthcare for everyone.

Our partners often say that “quality and affordability go hand in hand at Metrochem”. This has been possible due to our vertically integrated supply chain and our robust manufacturing process that we establish during the initial stages of product development. These processes allow us to not only match the desired specifications of our customers but also give us ample space to stay reasonable in terms of pricing, without hampering the quality standards.

We have a wide-reaching market presence that covers diverse geographical regions, including India, the United States, Europe, South East Asia, the Middle East, Africa, Latin America, as well as Asian countries like Japan, Korea, China, Pakistan, Bangladesh, Nepal, and Sri Lanka. Our goal is to transform into a multinational company, from being a multi-state player, in the near future by setting up centers in crucial global locations. This strategic move will give us a substantial advantage in expanding our global presence and operations.

We acknowledge our responsibility in promoting global health equity, which serves as a driving force for us to continuously enhance access to life-saving medications worldwide by aligning with varied rigorous delivery schedules.

What are Metrochem API’s growth plans?

Our objective is to become the foremost choice as an API supply chain partner. We plan to broaden our customer base through exceptional product quality and delivery services. At the same time, we aim to strengthen our global reputation as the most respected API partner, while diversifying our product portfolio to include candidates among varied therapeutic segments.

In addition to having a product portfolio covering 30 different therapeutic segments, we have taken steps to enter the field of oncology by establishing a dedicated facility for the production of oncology APIs. Furthermore, we plan to start manufacturing steroids and peptides soon. Our vision includes expanding into biopharmaceutical manufacturing within the next five years, all while maintaining our commitment to core small molecule API production.

Our goal is to achieve sustainable growth and establish ourselves as a leader in bulk drugs, catering to various market segments. To achieve this objective, we are actively working on developing an agile operational system that is aligned with our goals.

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Can you briefly take us through Metrochem API’s journey?

What are some of the key reasons behind Metrochem API’s success?

How has your manufacturing setup grown over the years? Which regulatory authorities have recognized your efforts?

What are Metrochem API’s target markets? How do you contribute towards sustainable healthcare?

What are Metrochem API’s growth plans?