The inspection by the US Food and Drug Administration (USFDA) was related to specific extended release applications made from the site. Receipt of EIR confirms the successful closure of the inspections, Strides Pharma Science said in a regulatory filing.
The share touched its 52-week high Rs 547.35 and 52-week low Rs 271.00 on 14 February, 2020 and 20 March, 2020, respectively.
"Strides...announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has entered into a definitive asset transfer and licensing agreement with Pharmaceutics International, Inc (Pii) to acquire 18 ANDAs for the US market," the company said in a filing to BSE.
With access to these products, Strides Pharma will significantly expand its niche offerings on its front end, which has grown multi‐folds to attain a quarterly revenue size of $66 million
However, the consolidated income of the company increased to Rs 744.66 crore in the October-December period, as against Rs 579.54 crore a year ago.
Strides Pharma Inc received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at its unit it December last year.
In a filing to BSE Strides said its "step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has received approval for Loratadine Softgel Capsules, 10 mg (OTC) from the United States Food & Drug Administration (USFDA)."
"Strides Pharma is one of our preferred picks in the midcap space," Macquarie said.
Ananth brings with him over three decades of top global pharmaceutical experience across both the technical and commercial functions, the statement said.
Diclofenac Potassium Softgel Capsule is a nonsteroidal anti‐inflammatory drug used to relieve pain and swelling from various mild to moderate painful conditions.
The existing unexpired contracts of expiry months August 2019, September 2019 and October 2019 would continue to be available for trading till their respective expiry.
'The company's formulations facility in Bengaluru, which was inspected by the United States Food and Drug Administration (USFDA) in May 2019, has received the EIR, thereby confirming the successful closure of the inspections,' the company said in a BSE filing.
The drugmaker was caught trying to dispose quality-control records, UDFDA said in a letter made public on July 16
The warning letter addressed to Arun Kumar, CEO and MD of the company, was issued on July 1 said its investigator found a blue binder containing CGMP records, including batch records for US drug products, discarded with other records in a 55-gallon drum in the scrap yard
The company received a warning letter from USFDA relating to Puducherry facility.
The company's consolidated revenue from operations stood at Rs 3,011.68 crore for 2018-19, against Rs 2,845.12 crore in the year-ago period.
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.