Granules India Limited announced that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc., located in Chantilly, Virginia, USA, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA). This development marks a significant milestone for the company's operations in the United States.

Inspection Details

The FDA conducted a Pre-Approval Inspection (PAI) for a first-to-file controlled substance Abbreviated New Drug Application (ANDA). The inspection resulted in one observation, which has been successfully resolved by the company.

Key Points

• Inspection Type: Pre-Approval Inspection (PAI)
• Purpose: First-to-file controlled substance ANDA
• Observations: One (resolved)
• Facility: Granules Pharmaceuticals, Inc., Chantilly, Virginia, USA

Significance of the EIR

The issuance of an Establishment Inspection Report by the FDA is a crucial step in the regulatory process. It indicates that the agency has completed its inspection and is satisfied with the company's response to any observations made during the inspection. The resolution of the single observation demonstrates Granules India's commitment to maintaining high quality standards and regulatory compliance in its US operations.

Company's Response

Granules India Limited promptly informed the stock exchanges about this development, in compliance with Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. This transparency in communication underscores the company's dedication to keeping its stakeholders informed about significant regulatory events.

The successful resolution of the FDA inspection observation and the subsequent receipt of the EIR could potentially strengthen Granules India's position in the US pharmaceutical market, particularly in the controlled substances segment. However, investors and stakeholders should continue to monitor the company's future regulatory interactions and market performance to assess the long-term impact of this development.

Granules India Limited , a prominent player in the pharmaceutical manufacturing sector, has announced a significant development regarding its API Unit-I facility located in Bonthapally, Hyderabad. The company has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) with a 'Voluntary Action Indicated' (VAI) classification.

Inspection Details

The inspection resulted in a single observation. Granules India promptly addressed this observation and submitted its response within the stipulated timeframe. The subsequent receipt of the EIR with a VAI classification underscores the company's commitment to maintaining high-quality standards in its manufacturing operations.

Facility Significance

The Bonthapally API Unit-I is noteworthy for several reasons:

• It is one of the world's largest single-site Paracetamol API manufacturing plants by volume.
• The facility also houses manufacturing plants for Metformin and Guaifenesin APIs.

Management's Perspective

Dr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India, commented on the development, stating, "The successful completion of this US FDA inspection and the subsequent receipt of the EIR with a satisfactory VAI classification reflects our commitment to maintaining the highest quality standards in our manufacturing operations."

Company Overview

Granules India Limited, incorporated in 1991, is a vertically integrated pharmaceutical company headquartered in Hyderabad. The company's operations span the entire pharmaceutical value chain, including:

• Active Pharmaceutical Ingredients (APIs)
• Pharmaceutical Formulation Intermediates (PFIs)
• Finished Dosages (FDs)

Global Presence

This latest development reinforces Granules India's position as a quality-focused pharmaceutical manufacturer with a strong global presence. The VAI classification from the US FDA for its Bonthapally API unit is likely to bolster confidence among the company's international clients and regulatory bodies.