Arene Lifesciences: Pioneering API Manufacturer for ARV/HIV with Exports Worldwide

S Gopi Krishnan,Director - Strategic Business
S Gopi Krishnan
Director - Strategic Business

The current scenarios in the pharmaceutical sphere of India portray successful manufacturing of generic drug and formulations; however, the country is heavily dependent on imports for bulk drug intermediates and Active Pharmaceutical Ingredients (APIs). Over 60 percent of APIs and over 80-90 percent of some specific APIs are sourced by India from other nations, reveals recent research. It is therefore imperative for the Indian pharma industry to focus on increasing investments in R&D and infrastructural facilities to boost the domestic manufacture of APIs and key intermediates at low cost. Also the Indian government should create a conducive environment and provide incentives to formulation producers to ameliorate the domestic Pharma capabilities.

Comprehending and executing these aspects is Hyderabad-based Arene Lifesciences Limited, which is primarily focused on R&D of highly prevalent diseases in the Indian context such as Antiretroviral (ARV) and Tuberculosis (TB). With chief emphasis on ARV-HIV APIs for various countries and WHO/PEPFAR-aided projects, Arene Lifesciences is engaged in the manufacturing of APIs and intermediates in many therapeutic areas entailing TB and others, as well as Amlodipine. The firm has extensive expertise in developing innovative and cost-effective route of synthesis for APIs (with DMFs registered in selected countries) and intermediates, thereby supporting patients with high-quality medicines for a good life with their families and dear ones. To further ensure unhindered availability of these products coupled with cost advantage, it involves in backward integrated production. Arene has, moreover, signed agreements with Medicines Patent Pool (MPP) and innovator companies to provide an advanced and latest line of top-notch treatment to patients with greater access and affordability.

Outstanding Expertise
Arene Lifesciences came into existence in 2004 in order to manufacture and export various key raw materials and intermediates across the Indian Pharmaceutical Industry. Recounting Arene Lifesciences’s journey so far, S Gopi Krishnan, Director – Strategic Business, explains, “While making significant investments in enhancing our manufacturing facilities, capacities and compliances to meet the demands of pharmaceutical companies for diverse APIs, we have positioned ourselves as their preferred supplier seeking to leverage our technical expertise, cost-effective manufacturing and capacities”. In 2016, the firm’s manufacturing plant (Unit I) was upgraded in terms of both manufacturing and quality management systems to comply
with the global ecosystem while its greenfield project for API and intermediates at Unit II is all set to commence commercial production. In fact, the most instrumental factor that keeps Arene going forward is that it actively seeks out to solve all of its customers’ challenges in the semi-regulated markets, be it on the regulatory front, quality, price or even time to market through the expertise and experience of its 350 employees across Unit I & II.

"Arene has, moreover, signed agreements with Medicines Patent Pool (MPP) and innovator companies to provide an advanced and latest line of top-notch treatment to patients with greater access and affordability"

Quality Compliant Drugs
To perform in sync with the vision – ‘To be recognized as one of the leading global manufacturers of quality API and their intermediates’, the leaders and diverse teams at Arene Lifesciences think out of the ordinary and develop innovative products. Across the ARV therapeutic groups, the company offers a spectrum of products encompassing commercial APIs in NNRTI, NRTI, Protease & Integrase Inhibitors, Rilpivirine (licensed with Janssen Sciences IRELAND UC) and Dolutegravir, Bictegravir, Cobicistat, Elvitegravir, Tenofovir Alafenamide, Lopinavir and Ritonavir (licensed with MPP). While conforming to the policy of cGMP compliance and risk management during product manufacturing, the firm is exposed to the emerging quality compliances through the promotion of skill development of various stakeholders and also participation in conferences, seminars and tradeshows. It has also filed U.S. DMF/WHO-PQ with authorities in regulated markets and would initiate supplies after procuring requisite approvals.

Teams Par Excellence
The masterminds behind the top-notch drugs are Arene Lifesciences’ hand-picked professionals who are constantly motivated to enhance their cognizance and skill sets in accordance with the unfolding technologies and methods in the pharmaceutical sphere. Ostensibly, this pursuit helps in keeping both the organization and also its professionals as the frontrunners in their respective fields of expertise. Breathing the core values of integrity, respect, passionate, progressive, responsibility and collaboration, Arene’s people are making a difference through their stellar work in the industry.

Harbouring a development expertise backed by an unwavering commitment to R&D investment, Arene Lifesciences has demarcated itself as a potential domestic manufacturer in India with a turnover of Rs.220 crore in 2017-18 (105 percent increase over the previous year). The firm also aspires to achieve around Rs.350 crore in 2018-19, which accounts to a 50 percent rise in last year’s revenue. Moreover, Arene believes that it has the potential to become a $500 million company with substantial export orientation by 2025 by wielding the power of appropriate strategies, and through the enablement of
optimistic policy and regulatory environment by Indian government.

Key Management:
C Satyanarayana Reddy, Chairman
A first-generation entrepreneur since 1992, C Satyanarayana is leading Arene Lifesciences from the front with great attention to detail and enormous trust in lateral strengthening.

K Satyanarayana Reddy, Managing Director
A Mechanical Engineer, K Satyanarayana has teamed with the Chairman of Arene Lifesciences since its inception.

S Gopi Krishnan, Director – Strategic Business
Besides holding a Masters Degree in Business Management, Gopi has 25+ years of experience in Business Development with big Pharma companies, as well as in-depth knowledge on HIV/AIDS and Anti TB markets in API and FDF.

K Madhu Kiran, Director
A Master’s degree holder in Business Management, Madhu has more than 20 years of experience in generic APIs and has worked with major multinational companies – VIZ Matrix Laboratories and Mylan Laboratories, prior to joining Arene Lifesciences.

S Varadha Rajan, CEO
A Master’s degree holder in Science from BITS Pilani and Business Management, Varadha has over 35 years of experience in Strategic Sourcing and Compliance in pharmaceutical industry, including more than 20 years with Lupin and Actavis (Allergan/Teva).

"The most instrumental factor that keeps Arene going forward is that it actively seeks-out to solve all of its customers’ challenges in the semi-regulated markets"

Arene Lifesciences in Spotlight:
•Arene is committed to transform new concepts in the pharmaceutical industry into innovative synthetic processes with assured quality, efficiency and sustainability.
•While compliance is at the foundation of its operations, Arene’s EHS Management System takes its performance beyond compliance.
•Being transparent and honest, Arene has managed to retain and expand its customer base through timely delivery of phenomenal products at reasonable prices as well as capacity building and collaboration between various regulators.
•Arene is contributing to market sustainability and lower prices by increasing fair competition among quality products and reducing the cost with chemistry improvements to increase the efficiency and productivity.

Quick Facts:
Year of Establishment:
APIs & Intermediates for Antiretroviral & Tuberculosis

Manufacturing Units:
•Unit I (Pashamylaram, Hyderabad)
•Unit II (Choutuppal, Hyderabad)