Aurobindo Pharma subsidiary receives one US FDA Observation at Tirupati Plant

Aurobindo Pharma subsidiary receives one FDA Observation at Tirupati Plant

In the latest regulatory development, APL Healthcare Limited, a subsidiary of pharmaceutical giant Aurobindo Pharma, has garnered attention from the US Food and Drug Administration (FDA). The FDA recently issued a ‘Form 483’ with a single observation following an inspection of APL Healthcare’s Unit IV facility located in Tirupati District, Andhra Pradesh. This noteworthy disclosure was made by Aurobindo Pharma in an official announcement to the stock exchanges on September 20, 2023.

The inspection, carried out meticulously from September 13 to September 19, 2023, resulted in the issuance of ‘Form 483’ containing one procedural observation. It’s essential to note that the FDA typically issues a Form 483 when it identifies certain procedural discrepancies during its facility inspections. Subsequently, companies are provided with guidance to implement corrective measures to address these issues.

Industry analysts have highlighted that a procedural observation is considered to be of minimal concern for companies in comparison to more critical issues like quality or data integrity lapses, which could potentially trigger severe regulatory actions.

In response to this observation, Aurobindo Pharma has committed to providing a timely and comprehensive response to the US FDA. The company has also expressed its intention to collaborate closely with the regulatory authority to expedite the resolution of the observation.

Analysts have been closely monitoring Aurobindo Pharma’s performance, projecting EBITDA margins in the range of 18-20 percent for the current fiscal year. These projections are attributed to changes in the product mix and a reduction in raw material costs, as highlighted in earlier reports. Additionally, industry experts anticipate robust growth in Aurobindo’s US business, driven by the upcoming launch of g-Revlimid in October 2023. This development is expected to be a significant catalyst for the company’s future endeavors in the pharmaceutical industry.

About Aurobindo Pharma:

Aurobindo Pharma Limited, headquartered in HITEC City, Hyderabad, India, is a multinational pharmaceutical manufacturing company specializing in the production of generic pharmaceuticals and active pharmaceutical ingredients.

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