Indian Pharma Sector Battles USFDA Tirade while Aurobindo Pharma Continues to Shine

Published By : 18 Jan 2016 | Published By : QYRESEARCH

It seems to be a rather tumultuous time for the Indian pharma sector. The United States Food and Drugs Association is locking in on multiple warnings and issues they have found with the state of India drug manufacturing locations. Market experts believe that it might take the Indian pharmaceuticals industry at least a year more to completely recover from the setback caused by the FDA bans on major companies for allegedly sub-standard manufacturing facility conditions.

There are some who are still optimistic however, as they state that the companies have historically had positive relationships with the U.S. They believe that this older track record will pick up over the next year and the hurdles will be successfully crossed. Abhishek Sharma, analyst of pharma industry over at IIFL, stated that companies such as Lupin are expected to bounce back faster due to the high level of transparency that they have always maintained. At the same time, companies such as Dr. Reddy’s Laboratories have already picked up the pace in rectifying the given warnings. They could even pick themselves up based purely on their pricings.

Glenmark has a “buy” rating, and so do a few other midcap stocks. The FDA warning letters have eventually served as critical reminders to Indian pharma companies to wake up and strive harder.

This lies in juxtaposition to Aurobindo Pharma, the Indian medicine company which is currently making waves with the number of approvals it is getting. The drug company has earned the final approval from the USFDA for the marketing and manufacture of two of its drugs, Paricalcitol and Tranexamic, in the U.S. markets.

The company has already announced plans to host the launch of the Tranexamic acid injection by the end of the current fiscal year. Paricalcitol will be available in capsule form in the Q1 of the next fiscal year.

Aurobindo Pharma issued a statement earlier, in which they said that the Tranexamic acid injection is the ANDA generic version of Cyklokapron injection by Phamacia and Upjohn Company. The product, now approved, has a potential market value of US$50 mn over the coming 12 months ended November 2015, as per the IMS.

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