Sun Pharmaceutical Industries Ltd  has moved closer to finalizing its acquisition of Ranbaxy Laboratories. The company have received approval from the Competition Commission of India, subject to certain product divestments and other terms. DCAT Value Chain Insights (VCI) examines the deal and the position of a combined company in the global pharmaceutical market. 

With approval from the Competition Commission of India (CCI) of India, Sun Pharmaceutical Industries has moved closer to its proposed acquisition of Ranbaxy Laboratories, a deal that was announced earlier this year. The proposed acquisition would create the fifth largest specialty generics company globally and the largest pharmaceutical company in India. An important consideration for a combined company would be the management of the company’s manufacturing and supply network. DCAT Value Chain Insights (VCI) examines the position of a combined Sun Pharma and Ranbaxy on a product and manufacturing basis.

Looking at the deal and a combined company
Subject to certain conditions, India’s CCI has approved the proposed merger of Sun Pharma and Ranbaxy. Sun Pharma and Ranbaxy had filed the notice with the CCI in May 2014 and sought its approval with respect to the proposed $3.2 billion acquisition of Ranbaxy by Sun Pharma from Daiichi Sankyo. Daiichi Sankyo holds a controlling stake in Ranbaxy, which it acquired in 2008/2009, and earlier this year, Daiichi agreed to sell its stake to Sun for $3.2 billion. Upon closing of the deal, Ranbaxy will be merged with Sun Pharma by means of a share swap, resulting in Sun Pharma as the surviving company and Ranbaxy as the company to be absorbed. At present, Daiichi Sankyo owns approximately 63.41% (ratio of voting rights held) of the shares of Ranbaxy. Daiichi Sankyo is scheduled to acquire approximately 9% of the shares of Sun Pharma as a result of the merger. One of the preconditions of the CCI order is that proposed combined entity of Sun Pharma and Ranbaxy divest seven products. These products constitute less than 1% of the combined entity’s revenues in India.

If the deal proceeds as planned, the combined entity of Sun Pharma and Ranbaxy will have operations in 65 countries, 47 manufacturing facilities, and a portfolio of specialty and generic products marketed globally, including 629 abbreviated new drug applications. On a pro forma basis, the combined entity’s 2013 revenues are estimated at $4.2 billion. Approximately 47% of sales will be from the US, 22% from India, and approximately 31% from the rest of the world.

One of the issues going forward for the combined company will be manufacturing quality, with both companies recently facing issues in this area. In November 2014, the US Food and Drug Administration (FDA) rescinded Ranbaxy’s previously granted tentative approvals for the company’s abbreviated new drug applications (ANDAs) for esomeprazole magnesium delayed-release capsules, 20 mg and 40 mg, and for valganciclovir hydrochloride tablets USP, 450 mg. Esomeprazole magnesium is the generic version of AstraZeneca’s gastrointestinal drug, Nexium, and valganciclovir hydrochloride is the generic version of Roche’s antiviral drug, Valcyte. In a statement, Ranbaxy said that the FDA said its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted. As a consequence, in FDA’s view, Ranbaxy forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets USP, 450 mg. Ranbaxy has had quality control issues at its manufacturing facilities, which included an FDA import alert issued earlier this year for active pharmaceutical ingredients manufactured (APIs) at Ranbaxy’s facility in Toansa, India.

In May 2014, the FDA issued a Warning Letter to Sun Pharmaceutical Industries for data-integrity issues and related cGMP violations at the company’s API and finished product manufacturing operations at the company’s facility in Vadodara, Gujarat, India. FDA issued the letter in response to an inspection of the pharmaceutical manufacturing facility made on November 13 to November 16, 2013. Also, earlier this year, Sun Pharmaceutical Industries Ltd announced that, as a part of its manufacturing consolidation in the US, it will cease manufacturing operations and close the Detroit facility of Caraco Pharmaceutical Laboratories, a subsidiary of Sun Pharma USA, the US arm of the Mumbai-based Sun Pharmaceutical Industries. Ltd. Earlier this year, Caraco issued a voluntary recall of select bottles of metformin. In 2009, US marshals, at the request of FDA, seized drug products and ingredients manufactured by Caraco at the Detroit facilities as well as two other facilities in Michigan at Farmington Hills and Wixom. The action followed Caraco’s failure to cGMP requirements and the issuance of several voluntary recalls. Caraco corrected the violations and resumed operations in 2012 at the Detroit facility.