News in brief

Dr. Reddy’s stock shares rises amid recent US FDA citations

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/monsitj)
(Image: Getty/monsitj)

Related tags: Stock exchange, Stock market, Fda, Form 483, India

Dr. Reddy’s Laboratories site in Visakhapatnam, India, was issued a Form 483 last month, yet shares rose after a more recent audit where zero observations were noted.

The company’s shares rose 3%​ in early trading on November 19, after an audit of the company’s site by the US Food and Drug Administration (FDA) in Andhra Pradesh, India, saw zero observations.

In a Bombay Stock Exchange filing, Dr. Reddy’s stated that the audit of its Formulations Srikakulum Plant Unit II received zero observations. The filing occurred during post-market hours on Friday, the following Monday shares jumped.

Between October 22 and October 30, 2018, however, Dr. Reddy’s site in Visakhapatnam, India, was observed by the FDA and it noted ten observations that led to the issuing of a Form 483 for its site. The observations generally regarded the Quality Unit and proper implementations to maintain sterile products.

The FDA states on its website that a Form 483​ is distributed at the conclusion of an inspection when observations regarding conditions that may constitute violations to the Food Drug and Cosmetic Act are seen.

The company’s Duvvada​ site, which primarily manufactures generic chemotherapy treatments, was issued a Form 483. A site in Bollaram​ and another in Jinneram Mandal​ were also recently given observations following audits.

Related news

Show more

Related products

show more

Strategies to Achieve Successful Approval & Launch

Strategies to Achieve Successful Approval & Launch

Catalent Pharma Solutions | 03-Sep-2020 | Data Sheet

There are several key considerations to how companies should approach commercial-scale manufacturing that may aid the success of their biologic’s launch...

Lactium, your ally to manage day to day stress

Lactium, your ally to manage day to day stress

Ingredia | 27-Aug-2020 | Product Presentation

Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Increasingly, consumers are looking for safe, reliable...

Single-Pass Tangential Flow Filtration

Single-Pass Tangential Flow Filtration

BioContinuum™ Platform - MilliporeSigma | 01-Aug-2020 | Application Note

Tangential flow filtration (TFF) is widely used in the biopharmaceutical industry for downstream processing applications. Typical TFF steps concentrate...

Related suppliers

Follow us


View more