Aurobindo Pharma Ltd. — Regulatory Filings 2018

Dec 24, 2018

Date: December 24, 2018

ToNATIONAL STOCK EXCHANGE OF INDIA LIMITEDExchange Plaza,Bandra Kurla Complex, Bandra (E),MUMBAI -400 051Company Code No. AUROPHARMA	ToBSE LIMITEDPhiroz Jeejeebhoy Towers,25thfloor, Dalal Street,MUMBAI -400 001Company Code No. 524804

Dear Sirs,

SUB: USFDA Approval for Vecuronium Bromide Injection

We enclose copy of the Press Release being issued by the Company.

Please take the information on record.

Thanking you,

Yours faithfully, For AUROBINDO PHARMA LIMITED

==> picture [74 x 19] intentionally omitted <==

B. Adi Reddy Company Secretary

NEWS RELEASE 24 December 2018, Hyderabad, India

Aurobindo Pharma receives USFDA Approval for Vecuronium Bromide Injection

Drug approved out of Unit IV facility

Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Vecuronium Bromide Injection, 10mg and 20mg. Aurobindo’s Vecuronium Bromide Injection is a generic equivalent of Organon’s Norcuron® Injection. The product will be launched in Q4FY19.

Vecuronium Bromide Injection is used as part of general anesthesia to provide skeletal muscle relaxation during surgery or mechanical ventilation. It is also used to facilitate endotracheal intubation. The approved product has an estimated market size of US$ 11 million for the twelve months ending September 2018 according to IQVIA.

This is the 58[th] ANDA to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable & ophthalmic products. Aurobindo now has a total of 397 ANDA approvals (369 Final approvals including 20 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

About Aurobindo Pharma Limited:

Aurobindo Pharma Limited (www.aurobindo.com) (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS, Bloomberg: ARBP:IN), headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company’s robust product portfolio is spread over 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and AntiDiabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.

For further information, please contact:

Krishna Kiran Investor Relations Phone: 040-66725401 / 66725000 Mobile: +91 98486 67906 Email: ir@aurobindo.com

Disclaimer:

This press release contain statements that may constitute “forward looking statements” including and without limitation, statements relating to product characteristics and uses, sales potential and target dates for product launch , implementation of strategic initiatives, and other statements relating to our future business developments and economic performance. While these forward looking statements represent our judgment and future expectations concerning the development of our business, a number of risks, uncertainties and other factors could cause actual developments and results to differ materially from our expectations. The company undertakes no obligation to publicly revise any forward looking statements to reflect future events or circumstances and will not be held liable for any use of this information.