API maker Granules Pharma simplifies structure involving US subsidiaries

The asset transfer will see Granules USA merge into Granules Pharma Inc, effectively consolidating the two entities into a single operational unit.

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26 Aug, 2025 12:21

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API manufacturer Granules Pharma has announced a restructuring to simplify its organisational structure, resulting in its American unit Granules USA transferring assets to Granules Pharma Inc and merging with it, and another American division Granules Consumer Health (GCH) turning into a Limited Liability Company, the company informed on March 25.

The exercise is aimed at reducing legal entities and simplify operating structure. "The Plan is expected to reduce the number of legal entities, simplify the legal, tax, and operational structures, create a unified holding structure, and improve the market focus," said Granules Pharma.

The management clarified that the move will not result in any change in the ownership of the subsidiaries, or the US business.

Granules India will hold control of Granules Consumer Health (GCH) through Granules Pharma Inc. GCH is a division of Granules India that provides affordable, generic over-the-counter (OTC) products in America.

The asset transfer will see Granules USA merge into Granules Pharma Inc, effectively consolidating the two entities into a single operational unit. Granules Pharma Inc, which is an FDA and DEA-approved facility and known for R&D and manufacturing capabilities gets strengthened as the primary operational hub in the US.

The management also announced the appointment of PN Baskaran as President - Head API Manufacturing & Operations, effective April 2. Baskaran has a strong background in API and formulations, with over 30 years of experience in operations management, specializing in manufacturing and supply chain.

Granules India's key segments include its product portfolio, which comprises of nearly two-third of the revenue for FY24, followed by the API business. The company has presence in more than 80 countries, with a predominant share of income from North America.

The management has lined up a capex spend of around Rs 500 crore for FY26, with a focus on expanding production.

The API player has been working to resolve issues raised by the USFDA at its Gagillapur facility in Hyderabad, which had received an official action indicated (OAI) classification, after getting six Form 483 observations following an inspection in September 2024. According to Granules India, it has completed 90% of the corrective and preventive actions (CAPA), and intends to close the remaining by March 2025.

Read More: US FDA issues warning letter to Granules India's Gagillapur facility

The transition of GCH into an LLC may involve regulatory approvals or financial implications, though the company has not specified any details in the announcement.