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Sun Pharma, SPARC Shares Affected by Approval Revocation by USFDA

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Published on : Sep 28, 2015

The shares of Sun Pharma and SPARC, its subsidiary, have come close to the bear during Monday’s trade. The drop was caused when the United States Food and Drug Association revoked one of the approvals previously made to the pharma company. The revocation was done citing problems in the manufacturing quality at the Sun Pharma production site.

Meanwhile, SPARC had gotten the final approval for a drug launch. The approval by USFDA was later rescinded on the grounds of the manufacturing facility not being of acceptable standards on the date of approval.

After the revocation, the SPARC shares slipped 4.5% to a new low of Rs. 368.50 on the Indian exchange. Shares of the parent company, Sun Pharma, dropped 3.79% to hit Rs. 857.50.

The result was viewed by most as negative in terms of remedial efforts that the company was undertaking in its facility at Halol. The pharma giant was issued the Form 483 one year ago for unacceptable conditions of its Halol facility. The new result might cause major disruptions in the supply chain and also affect the pipeline drugs that are awaiting approval, according to analysts.

The Halol facility, owned by Sun Pharma, was supposed to manufacture Elepsia XR TM. Sun Pharma is currently working with the USDFA in finding solutions for the cGMP violations that had happened at the facility. The company has since taken multiple corrective measures.

Analysts still say that the Halol facility resolution will take time to achieve

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