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As per the USFDA, the companies are recalling the product due to deviation from the current good manufacturing practices
The specified batch, which is being recalled, has been manufactured at Unichem's Goa-based facility
Go ahead for inhaler launch in the US and resolution of plant compliance issues are other triggers
Brokerage firm Prabhudas Lilladher has upgraded Lupin's stock to 'Buy' from earlier 'Reduce' with target price of Rs 978
The inspection at the facility was carried out by the US Food and Drug Administration between November 26, 2018
The stock of the drug maker has rallied 47 per cent in the past six trading days, and was quoting close to its 52-week high level of Rs 882
The recent gains came on Monday after the company received the USFDA approval for its Nagpur facility
The company's shares surged 4.14% to Rs 820.40 after they received the inspection report (EIR) from the US drug regulator
Cipla gets nod for drug from USFDA earlier than expected; Lupin in fray
The near-term worry for the company is the ongoing investigation by the US Department of Justice related to price fixing and cartelisation by generic companies
The United States Food and Drug Administration (USFDA) carried out the inspection of the company's Vizag API manufacturing facility between January 13, 2020 and January 17, 2020.
High costs have hit Q3 margins, while multiple one-offs have impacted firm's bottom line
The USFDA issues observations by means of Form 483 notifying a company's management of objectionable conditions at the facility inspected
The Mumbai-based company's product is the generic version of Taro Pharmaceuticals Inc's Topicort Ointment.
The product is a generic version of Novartis Pharmaceuticals Corporation's Myfortic delayed-release tablets in the same strengths, it added
Last month, Lupin's board had approved the stake sale in Kyowa
Trading calls by Jay Anand Thakkar, CMT -Assistant Vice President - Equity Research, Anand Rathi Shares and Stock Brokers
The company will now focus on specialty products in Japan; it is open to inorganic opportunities, especially in India
The medicine is indicated for prophylaxis and treatment of chronic asthma in adults and children 12 years of age and older, it added.
While pricing pressure in the US generics market remains in low single digits, large product approvals are crucial to boost sales