Sun Pharma receives Warning Letter for Halol facility

Sun Pharma receives Warning Letter for Halol facility 

Mumbai, December 19, 2015: Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharma) today announced that it has received a Warning Letter from the US FDA as a result of the September 2014 inspection, for its facility located at Halol, Gujarat in India. 

Sun Pharma responded to the US FDA inspection observations with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its Quality Systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner. 

Commenting on the development, Dilip Shanghvi, Managing Director, Sun Pharma said, "While our team is working hard to ensure that the commitments made to the US FDA in September 2014 are fully completed, we will continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the US Agency is completely satisfied with our remediation of the Halol facility. Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market. We are pledged to being cGMP compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications." 

Since the inspection in September 2014, Sun Pharma has communicated regularly with the US FDA on the progress of its remediation and on issues of product supply. It has provided periodic updates to the US FDA on its commitments. Post the September 2014 inspection, the US FDA has withheld future product approvals from the Halol facility. This situation may continue until all issues are resolved. Sun Pharma expects to request a re-inspection by US FDA upon completion of its remediation commitments. 

Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations to its customers and the patients who use its drugs in the United States and around the world. 

Sun Pharma will respond to this Warning Letter with a detailed plan within the stipulated time frame. 

Conference call (06.00 pm IST, December 19, 2015) 

The Company will conduct an hour long call at 06.00 pm IST on December 19, 2015 where senior management will discuss and answer questions from participants.  To participate in this conference call, please dial the numbers provided below, five to ten minutes ahead of the scheduled start time.  The operator will provide instructions on asking questions before the call.  You can also hear the call via an audio webcast, details of which will be announced later on the Company website, www.sunpharma.com.  A transcript of this conference call will also be available on the website.

Summary of events 

Event

Date and time

Telephone number/ website

Conference call

06.00 pm IST, 
December 19, 2015

Primary Number :     +91 22 3960 0899 
Secondary Number : +91 22 6746 8324 
 Via audio webcast, details of which will be made available on www.sunpharma.com

Replay of conference call

December 19, 2015 to 
December 27, 2015

India: +91 22 3065 2322 
ID: 74861 
Via audio webcast playback, details of which will be made available onwww.sunpharma.com

 

 

About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050)

Sun Pharma is the world's fifth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business, economies of scale and an extremely skilled team enable us to deliver quality products in a timely manner at affordable prices. It provides high-quality, affordable medicines trusted by customers and patients in over 150 countries across the world. Sun Pharma's global presence is supported by 49 manufacturing facilities spread across 6 continents, R&D centres across the globe and a multi-cultural workforce comprising over 50 nationalities. The consolidated revenues for 12 months ending March 2015 are approximately US$ 4.5 billion, of which US contributes US$ 2.2 billion. In India, the company enjoys leadership across 13 different classes of doctors with 30 brands featuring amongst top 300 pharmaceutical brands in India. Its footprint across emerging markets covers over 100 markets and 6 markets in Western Europe. Its Global Consumer Healthcare business is ranked amongst Top 10 across 4 global markets. Its API business footprint is strengthened through 14 world class API manufacturing facilities across the globe. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities comprising about 2,000 scientists and R&D investments of over 7% of annual revenues. For further information please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

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We would be happy to host one-on-one, group and telephone meetings for updates on the Company.  If you wish to setup such a meeting, feel free to get in touch with us.  In-person meetings can be at our office or elsewhere depending on mutual convenience.  Our contact details: 

Nimish Desai 
Tel : +91 22 4324 4324, Ext 2778 
Tel Direct : +91 22 43242778 
Mobile : +91 98203 30182 
E mail: [email protected]

Frederick Castro 
Tel : +91 22 4324 4324, Ext 2777 
Tel Direct : +91 22 43242777 
Mobile : +91 99206 65176 
E mail : [email protected]

 

Ajay Khodke

Manager 
Investor Relations & Corp. Comm.

 

Sun Pharmaceutical Industries Ltd

SUN HOUSE, 201 B/1, Western Express Highway, 
Goregaon (East), Mumbai, 
Maharashtra (India) – 400 063

Telephone:

+91 22 4324 2779

 

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