MOSL: SUN PHARMA (Buy)-Halol 483 out-Resolution of issues key for future product approvals
Sun Pharma: Halol 483 out; Resolution of issues key for future product approvals
(SUNP IN, Mkt Cap USD14.5b, CMP INR430, TP INR515, 20% Upside, Buy)
- The USFDA inspected Sun Pharma’s (SUNP) Halol facility from 3rd- 13th Dec’19 and has issued form 483 with 8 observations.
- The observations are largely related to out of specification (OOS), controls on monitoring of data related to the environment, procedure of sampling at end of the filling process, deficiency in aseptic area processing, control procedures to monitor variability in characteristics of in-process and finished products, and timely implementation of Corrective actions on critical alarms.
- We expect Sun Pharma to implement corrective and preventive action (CAPA) and to resolve the issues highlighted in Form 483 in 3-4 months. Particularly, the issue related to sampling at end of the filling process is important from future ANDA approval perspective.
Sun Pharmaceutical and its subsidiaries are principally engaged in developing, manufacturing and marketing generic pharmaceutical products and bulk drugs. Co.'s products are mainly for the following therapy areas: psychiatrists, neurologists, gastroenterologists, diabetologists, chest physicians, consultant physicians, orthopedics, oncologists, gynecologists, ophthalmologists and cardiologists. Generic names of three principal products of Co. is Pentoxifyline, Pentoparzole Sodium, and Metformin Hydrochloride. Co.'s business can be divided into four segments: Indian branded generics, U.S. generics, international branded generics (ROW) and Active Pharmaceutical Ingredients (API).
Motilal Oswal Financial Services Ltd. is a reputed name in Financial Services and Online Trading with group companies providing services such as Private Wealth Management, Retail Broking and Distribution, Institutional Broking, Asset Management, Investment Banking, Private Equity, Commodity Broking, Currency Broking, Principal Strategies & Home Finance.
Motilal Oswal Securities is a group company of Motilal Oswal Financial Service Limited which started as a stock trading company and has blossomed into well diversified firm offering a range of financial products and services. Motilal Oswal has built a reputation as the source for best stock trading company and this has taken a wealth of experience, knowledge and expertise, constantly working in tandem, over the years.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.