Wockhardt Limited's Regulatory Woes: Hard Work Ahead

Wockhardt Limited's Regulatory Woes: Hard Work Ahead
Case Code: BSTR450
Case Length: 13 Pages
Period: 2010 - 2014
Pub Date: 2014
Teaching Note: Not Available
Price: Rs.300
Organization: Wockhardt Limited
Industry: Pharmaceuticals
Countries: India; Global
Themes: Globalization, Competitive Strategy, International Management
Wockhardt Limited's Regulatory Woes: Hard Work Ahead
Abstract Case Intro 1 Case Intro 2 Excerpts

Introduction

In the third quarter of FY2014, Wockhardt Limited (Wockhardt), an India-based pharmaceutical and biotechnology company, registered a 30% decline in net profit at Rs.3.04 billion from Rs. 4.28 billion in the same quarter of the previous year. The company's total sales also fell from Rs.14.285 billion to Rs.13.227 billion in the same period. Analysts attributed the decline in profit to the import alert from the US Food and Drug Administration (USFDA) and the resultant inventory write-offs. The company also recorded a 30% decline in sales in the US market which contributed 45% of its international revenue. Not only in the international market but in the domestic market too, the company's performance suffered a setback with its sales growing by only 6% compared to the 13-14% growth reported by its competitors.

Wockhardt's regulatory issues started in May 2013 when the USFDA banned imports from its manufacturing facilities at Waluj, Aurangabad, in Maharashtra, Western India, citing violation of good manufacturing practices. The ban effectively stopped Wockhardt's exports to the US and cost the company US$500 million in sales. Later, the Chikalthana unit in Aurangabad also received an import alert from the USFDA. To add to its woes, the company received warnings from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) too over data integrity issues...

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