Cipla gets SAHPRA approval for new Triple combination Antiretroviral Drug

Shalini | Myequity news | Date : 11-09-2018 21:10:00 IST

The South African Health Products Regulatory Authority (SAHPRA) has approved Cipla’slatest first-line triple-combination antiretroviral (ARV) treatment for HIV. The new combination medicine commonly referred to as TLD, is a combination of tenofovir (TDF), lamivudine (3TC) and dolutegravir (DTG).

Head of Manufacturing for Cipla South Africa, Ajay Kumar Pal, said the reason for the new formulation complexity related to the three different processes required for the three active pharmaceutical ingredients (APIs). In addition to the considerable technology and infrastructure investment of more than R48m (including a machine worth R16m), there are also additional complexities pertaining to the double coating and compression of the tablet, and the product also undergoes exhaustive testing at different stages of manufacturing.

Cipla’s investment in infrastructure aligns with the government’s request to support local industries to stimulate economic growth. Manufacturing and investment in infrastructure have been identified by the World Bank, and in the United Nations Sustainable Development Goals, as the multiplier for job creation, as well as economic growth and development in any country. Cipla continues to work closely with government in this regard and to ensure that people have access to affordable treatment.

Cipla has a legacy of pioneering affordable ARVs: in 2001, it produced the world-first three-in-one fixed combination drug, available at less than $1 per day, thereby enabling countless more patients to have access to life-saving medication. This new fixed-dose combination – an addition to Cipla’s comprehensive portfolio of HIV medication – is recommended by the World Health Organisation (WHO) as a preferred first-line regimen.

Cipla South Africa CEO, Paul Miller, said, “We’re always focused on ensuring that patients benefit by having access to quality, affordable ARVs. DTG is considered a best-in-class medicine providing many clinical benefits for people living with HIV. With DTG replacing efavirenz (EFV) in the first-line fixed dose combination treatment thereby reducing the likelihood of treatment failure, TLD has the potential to reduce overall treatment costs.”

According to UNAIDS, “antiretroviral therapy using dolutegravir has several advantages over other regimens, including clinical superiority, improved side-effect profile, and reduced risk of viral resistance”.

About Cipla

Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. Our strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments are well-known. Our 44 manufacturing sites around the world produce 50+ dosage forms and 1,500+ products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT Mar’18), 4th largest in the pharma private market in South Africa (IQVIA MAT Jun’18), and is among the most dispensed generic players in the US. For over eight decades, making a difference to patients has inspired every aspect of Cipla’s work. Our paradigm-changing offer of a triple antiretroviral therapy in HIV/AIDS at less than a dollar a day in Africa in 2001 is widely acknowledged as having contributed to bringing inclusiveness, accessibility and affordability to the centre of the movement.

About Cipla South Africa

Cipla Medpro South Africa (Pty) Limited is the third largest pharmaceutical manufacturer in the country. Through Cipla’s ethos of ‘Caring for Life’, Cipla Medpro produces world-class medicines at affordable prices for the public and private sectors, advancing healthcare for all South Africans.

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