According to the USFDA, an OAI means regulatory and/or administrative actions will be recommended for the facility which was inspected after it determines if the areas evaluated were in compliance with applicable laws and regulations.
The company had earlier in March announced receiving approval from the United States Food and Drug Administration for the greenfield oral dosage facility in Singapore.
The United States Food and Drug Administration (USFDA) has approved the product in the strengths of 10 mEq (750 mg), 15 mEq (1,125 mg), and 20 mEq (1,500 mg), Strides Pharma Science said in a regulatory filing.
Macquarie expects the US market to be a key margin driver for the company
Geojit is bullish on Strides Pharma Science has recommended buy rating on the stock with a target price of Rs 530 in its research report dated January 31, 2019.
After released a pledge on 10 lakh shares, promoter shareholding that pledged with lenders stood at 69.76 lakh shares or 7.79 percent out of total promoter holding of 2.79 crore shares or 31.24 percent.
The approved product is a generic version of Mylan Pharmaceuticals Inc's Triamcinolone Acetonide cream.
"The company's formulations facility (KRSG Gardens) in Bangalore which was inspected by the US Food and Drug Administration (USFDA) in August 2018 and November 2018, has received the Establishment Inspection Report (EIR), thereby confirming the successful closure of the inspections," Strides Pharma Science said in a BSE filing.
The company's step-down subsidiary Strides Pharma Global Pte Ltd has approved the sale of its entire Australian business to the Arrow-Apotex merged entity, Strides Pharma Science said in a filing to the BSE.
Strides Pharma Global, Singapore, has received approval for Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP in the strengths of 236 grams/2.97 grams/6.74 grams/5.86 grams/22.74 grams/4 Liter from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a filing to BSE.
Strides will receive around $42 million towards full and final release of the General Claims Escrow immediately.
This is the verbatim transcript of Strides Pharma Science management call with analysts.
The joint venture -- Strides Vivimed -- received approval from the US Food and Drug Administration (FDA) for its Albendazole Tablets USP 200 mg
Strides Vivimed Pte Ltd, Singapore, a 50:50 joint venture with Vivimed Labs, has received approval from the United States Food & Drug Administration (US FDA) for Albendazole tablets in the strength of 200 mg, Strides Pharma Science said in a BSE filing.
The company's board has approved participation in the Series B fundraiser of Stelis Biopharma with a commitment of USD 15 million, Strides Pharma Science said in a regulatory filing.
Under the terms of agreement, SUDA will receive an upfront cash payment of USD 0.4 million and a further payment of USD 0.6 million on reaching certain milestones including the pilot first-in-man clinical study, submission and approval of the product in the US," Strides Pharma Science said in a BSE filing.
"Board of directors have approved the execution by Strides of definitive agreements with funds advised by ICP-III Investment Advisors (ICP) to provide growth capital and focused attention to its Consumer Healthcare Business (CHC)," Strides Pharma Science said in a BSE filing and added that ICP would provide the business with a USD 20 million capital for growth.
The company had posted a net profit of Rs 11.73 crore for the corresponding period of the previous fiscal, Strides Pharma Science said in a filing to BSE.