The United States Food and Drug Administration (USFDA) conducted the inspection between August 5-8, 2019, Lupin said in a filing to the BSE. The inspection for the oral solid facility closed without any Form 483 observation, it added. Form 483 notifies the company's management of objectionable conditions.
The Nagpur facility is Lupin's largest and most advanced oral solid dosage facility.
Net Sales are expected to increase by 6.2 percent Y-o-Y (down 5.1 percent Q-o-Q) to Rs. 4,195.2 crore, according to Emkay.
Morgan Stanley also has overweight rating on Lupin with a target price at Rs 1,003, implying 47 percent potential upside from current levels as it believes the share price will rise in absolute terms over the next 30 days.
The GMP (good manufacturing practice) Certificate was issued following an inspection conducted by PMDA between May 14, 2019 and May 17, 2019, Lupin said in a regulatory filing.
Trends on SGX Nifty indicate a negative opening for the broader index in India, with a 41 points loss compared to Monday’s close of 11,167.
As per IQVIA MAT August 2019 data, Mycophenolate Mofetil capsules USP, 250 mg, had annual sales of around $ 53 million in the US, Lupin said.
In his most recent engagement, Johnny was the global head of quality and compliance at Apotex.
The capsules are indicated for prevention and treatment of seizures occurring during or following neurosurgery and for treatment of tonic-clonic and psychomotor seizures.
Prior to joining Bayer, Jon Stelzmiller spent 12 years at Pfizer Inc.
Lupin says it is the first generic company to get an approval for generic Inderal-LA capsules for the Canadian market.
As per IQVIA MAT June 2019 data, Ethacrynic Acid tablets had annual sales of around USD 24 million (about Rs 170 crore) in the US.
The company has received approval from the United States Food and Drug Administration (USFDA) for its Fosaprepitant for injection, 150 mg single-dose vial, Lupin said in a statement.
Lupin entered into a licensing agreement with Germany’s Boehringer Ingelheim to develop and commercialise a novel anti-cancer compound in a deal valued at $700 million.
The drug is expected to take around five-to-seven years to be commercialised. Lupin will receive an upfront payment of $20 million
Trends on SGX Nifty indicate a positive opening for the broader index in India, with 0.17 percent gain or 19 points. Nifty futures were trading around 11,071-level on the Singaporean Exchange.
As per the agreement, Creso has given Pharma Dynamics sole distribution rights of its products across South Africa, Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Angola, Mozambique and Uganda, Lupin said in a statement.
Trends on SGX Nifty indicate a negative opening for the broader index in India, with 0.08 percent loss or 9 points. Nifty futures were trading around 10,716-level on the Singaporean Exchange.
The product is a generic version of Eli Lilly and Company's Prozac tablets in the same strengths, it added.
The cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients, Lupin said.
Motilal Oswal is bullish on Lupin has recommended buy rating on the stock with a target price of Rs 885 in its research report dated August 08, 2019.
The inspection by the the USFDA for facility at Nagpur was carried out between August 5, 2019 and August 8, 2019. It closed without any 483 observations.
The drug firm on August 7 reported a 49.46 percent rise in consolidated net profit to Rs 303.05 crore for the quarter ended June 30, 2019 on account of robust sales in India and overseas.