Aurobindo Pharma’s Subsidiary Secures WHO Approval

Last year, in September, the Prequalification Unit Inspection Team (PQT-INS) of the World Health Organization (WHO) inspected Unit IV of APL Healthcare Limited, which is one of the wholly-owned subsidiaries of Aurobindo Pharma Ltd. Regarding the same, in March 2024, the World Health Organization gave its approval.

Details of the Inspection 

Between September 11 and September 15, 2023, the Prequalification Unit Inspection Team of the World Health Organization conducted an inspection at Unit IV of APL Healthcare. The Unit IV of the company is a formulation manufacturing facility located at Menakuru Village, Naidupeta Mandal, Tirupati District, Andhra Pradesh.

According to APL Healthcare Limited, based on the inspection findings, the PQT-INS has decided to recommend to the Prequalification Assessment Team that the Unit IV facility be named as a manufacturing site in the dossier for Dolutegravir, Lamivudine, Tenofovir Disoproxil Fumarate Tablets (50/300/300 mg).

On March 1, 2024, the company got final permission from the United States Food and Drug Administration (USFDA) for the manufacturing and marketing of Fingolimod Capsules, 0.5 mg, which is bioequivalent and therapeutically equal to the reference listed drug (RLD) and Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation. The product is set to be launched in March 2024.

Additionally, in February 2024, the company obtained seven observations from the United States Food and Drug Administration after inspecting the injectable facility of Eugia SEZ Pvt Ltd, a 100% step-down subsidiary of Aurobindo Pharma Ltd, located in Mahaboobnagar district of Telangana.

In December 2023, another wholly-owned subsidiary of Aurobindo Pharma Ltd, Eugia Pharma Specialities Ltd, got approval from the US health regulator to manufacture and market generic Posaconazole injection. This injection is used to prevent serious fungal infections. The company got approval for the injection of 300 mg/16.7 mL (18 mg/mL). The company stated that it is bioequivalent and therapeutically equal to the RLD, Noxafil Injection, 300 mg/16.7 mL (18 mg/mL), of Merck Sharp & Dohme LLC (Merck).

About Aurobindo Pharma Limited

Aurobindo Pharma Limited is involved in the development, manufacturing and sale of Active Pharma Ingredients (API) and formulations. The company has 25 state-of-the-art manufacturing and packaging facilities. They supply their products all over India and also export to more than 150 countries in the world. Aurobindo Pharma Limited has 9 R&D centres with more than 1,500 scientists and analysts involved. The company has about 15 formulation manufacturing

and packaging facilities located across the world in various regions, such as India, the USA, Brazil and Portugal. These facilities are accredited by regulatory bodies such as the US FDA, the European Medicines Agency (EMA), and ANVISA (Brazil).

On March 12, 2024, Tuesday, the share price of Aurobindo Pharma Limited opened at ₹1,081.45 on the NSE.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.