Moneycontrol Bureau
Sun Pharmaceutical Industries shares rebounded nearly a percent after slipping 1.5 percent in early trade on regulatory concerns as some testing programmes were not adequately designed at Halol Plant. The USFDA had inspected Halol unit from November 17 to December 1, 2016 and issued a Form-483 citing nine inspectional observations. However, analysts feel that observations issued for Halol unit are not serious in nature. They are still hopeful of early clearance from the US Food and Drug Administration to Halol unit. According to them, these are largely related to standard operating procedures and not related to data integrity.
Surya Patra of PhillipCapital believes that most of these observations are about adequacy in system and test procedures but not about data generation aspect.
He feels all the nine observations are around test practices followed in the system. He doesn't anticipate any escalation of the matter. Patra thinks possibly it may take some time for Sun Pharma to convince about the processes or practices followed in the systems to get its plant cleared from USFDA.
He said the brokerage house remains positive on the stock with a target price of Rs 525 per share.
Following are nine observations issued by USFDA after inspection of Halol unit, Gujarat:-1) Field alert reports have not submitted in three working days of receipt of information2) Drug products do not bear expiration date determined by apt stability3) Testing programme is not adequately designed to assess drug product stability4) Establishment of test procedures is not fully reviewed by quality control unit5) Accuracy of test methods has not been established6) Sound & appropriate lab control mechanisms are not established7) Procedures applicable to quality control unit are not fully followed8) Changes to procedures are not drafted & reviewed by apt organisational units9) Changes to procedures are not approved by appropriate organisational units
Meanwhile, Sun Pharma and Israel-based Moebius Medical have entered into an exclusive worldwide licensing deal to further develop MM-II, a novel pharmaceutical candidate for the treatment of pain in osteoarthritis.
MM-II is a novel non-opioid product that leverages the physical properties of proprietary liposomes to lubricate arthritic knee joints, thereby reducing friction and wear, consequently leading to joint pain reduction.
MM-II is an intra-articular biolubricant injection which is being developed to provide symptomatic relief of mild-to-moderate osteoarthritis pain. The product is based on patent-protected technology licensed by Moebius Medical from the Hebrew University of Jerusalem, Technion Israel Institute of Technology and Hadassah Medical Centre.
At 11:33 hours IST, the stock was quoting at Rs 678.70, up Rs 2.40, or 0.35 percent on the BSE.Posted by Sunil Shankar Matkar
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