Aurobindo Pharma , a leading Indian pharmaceutical company, has announced the completion of a United States Food and Drug Administration (US FDA) inspection at one of its subsidiary's manufacturing facilities. The inspection, which took place at Unit-I of Apitoria Pharma Private Limited, resulted in the issuance of a Form 483 containing five procedural observations.

Inspection Details

The US FDA conducted the inspection at Unit-I, an API (Active Pharmaceutical Ingredient) manufacturing facility of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma. The facility is located in Borpatla Village, Hatnoor Mandal, Sangareddy District, Telangana. The inspection was carried out from August 21 to August 29.

Form 483 Observations

At the conclusion of the inspection, the US FDA issued a Form 483 with five observations. Aurobindo Pharma emphasized that these observations are procedural in nature, and importantly, no data integrity concerns were identified during the inspection process.

Company Response

Aurobindo Pharma has stated that they will respond to the US FDA within the stipulated timelines regarding the observations. The company also reaffirmed its commitment to maintaining the highest quality manufacturing standards across all of its facilities globally.

Impact on Operations

In its communication to the stock exchanges, Aurobindo Pharma clarified that there is no impact on the company's financials or operations due to this regulatory action. This suggests that the company does not anticipate any significant disruptions to its business activities as a result of the FDA inspection outcome.

Additional Corporate Update

In a separate announcement, Aurobindo Pharma provided an update on a previously disclosed corporate restructuring. The company informed that the transfer of shares of CuraTeQ Biologics s.r.o., held by Helix Healthcare B.V., to Curateq Biologics B.V. (all wholly owned subsidiaries of Aurobindo Pharma) will be completed by September 30. This extension from the original August 31 deadline is due to pending receipt of updated business register documents from authorities in The Netherlands.

Aurobindo Pharma continues to navigate regulatory inspections and corporate restructuring as it maintains its position in the global pharmaceutical market. The company's proactive communication with regulatory bodies and shareholders underscores its commitment to transparency and compliance in its operations.

Aurobindo Pharma , a leading Indian pharmaceutical company, has achieved a significant milestone in its international expansion efforts. The company's subsidiary, CuraTeQ Biologics s.r.o., has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar product Dazublys.

Regulatory Approval Details

Dazublys, a trastuzumab biosimilar, has been granted marketing authorization by the MHRA, allowing CuraTeQ Biologics to market the drug in the United Kingdom. This approval marks an important step for Aurobindo Pharma in expanding its presence in the UK's biosimilar market. The drug is indicated for treating HER2-positive breast and gastric cancers.

European Union Approval

According to the company's regulatory filing, Dazublys had already received marketing authorization in the European Union from the European Commission (EC). This dual approval in both the UK and EU markets significantly enhances the product's potential reach.

Growing Biosimilar Portfolio

The approval of Dazublys represents CuraTeQ's fourth biosimilar to receive MHRA approval. The company's expanding portfolio of approved biosimilars in the UK now includes:

It's worth noting that Zefylti™, Dyrupeg™, and Dazublys™ have also secured approvals in the European Union, further strengthening Aurobindo Pharma's position in the European biosimilar market.

Strategic Importance and Future Plans

This regulatory milestone underscores Aurobindo Pharma's commitment to expanding its biosimilar portfolio and strengthening its presence in key international markets. The approval of Dazublys in the UK is expected to contribute to the company's growth in the highly regulated and competitive European pharmaceutical landscape.

In addition to its biosimilar developments, Aurobindo Pharma has entered into discussions for potentially acquiring Zentiva, a European pharmaceutical company. The talks are currently at early stages, with a possible announcement expected within two months. Aurobindo Pharma's CFO has indicated that the company would prefer deals with single-digit multiples and exercise caution to avoid overpayment.

Financial Position

Aurobindo Pharma currently holds $140.00 million in assets and generates 75% of its revenue from US and European markets, highlighting the importance of these regions to the company's overall business strategy.

As biosimilars continue to gain importance in healthcare systems worldwide due to their potential for cost savings and increased patient access, Aurobindo Pharma's progress in this segment positions the company well for future growth opportunities in the global pharmaceutical market.

Despite these positive developments, Aurobindo Pharma's shares declined 1.59% to ₹1050.40 in recent trading.