Zydus gets USFDA approvals for Atorvastatin Calcium Tablets, Dimethyl Fumarate Delayed-Release capsules
Zydus Cadila has received final approval from the USFDA to market Atorvastatin Calcium Tablets in the strengths of 10 mg, 20 mg, 40 mg, and 80 mg (US RLD - Lipitor).
It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad, as per the company's filing with the BSE.
The group has also received a tentative approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg (US RLD - Tecfidera capsules). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.
Glenmark gets final USFDA approval for gMepron suspension
Glenmark Pharma has said that it has been granted the final USFDA approval for Atovaquone oral suspension 750 mg/5 mL. This is a generic version of GlaxoSmithKline’s Mepron Oral Suspension 750 mg/5 mL.
According to IQVIATM sales data, the Mepron oral suspension 750 mg/5 mL had annual sales of $119.1mn for the 12-month period ending September 2018.
Besides Glenmark, there are five generic companies (Lupin, Amneal, Hetero drugs, Paddock, and Apotex) who have approvals for this drug. The price of this drug has decreased by ~17% in the last two years in the US market. Considering the competition, we believe that this could be $4-5mn drug for Glenmark.
Indoco Remedies clears USFDA warning letter on Goa facilities
Indoco Remedies has said that the USFDA inspected its sterile facility (Plant II) and solid dosages facility (Plant III) situated at Verna Industrial Estate, Goa, from 14-21 November, 2018. The inspection has concluded with Indoco receiving two minor observations.
The company has said that none of these are repeat observations. However, it has termed this inspection to have cleared both the facilities, which is a positive development for both the plants.
This facility had received a Warning Letter from the USFDA in March 2017.
GMR Infra gains after arm signs agreement to develop port in AP
Shares of GMR Infra climbed 2% in intraday trade on Thursday after the company’s arm -- Kakinada Gateway Port Limited (KGPL), a subsidiary of Kakinada SEZ Ltd (KSEZ), signed a concession agreement with the Government of Andhra Pradesh (GoAP) for developing a green-field commercial port.
"As per the agreement, the company will develop the port on a Design, Build, Finance, Operate, and Transfer (DBFOT) basis at Kona in East Godavari District, Andhra Pradesh," the company said in a press note to the exchanges after market hours on Wednesday.
Vakrangee locked in 5% upper circuit as EOW issues clean chit
In a big relief to Vakrangee, the Economic Offences Wing (EOW) issued a clean chit to the company with respect to a price and volume manipulation complaint. Reacting to this, shares of the company climbed 5% in Thursday’s morning session and are currently locked in upper circuit.
Earlier, EOW had received a complaint for price and volume manipulation against the company and its promoter, managing director, and CEO Dinesh Nandwana, Vakrangee said in a press release to the exchanges on Thursday. Based on the complaint, EOW had sought an explanation from the company.
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