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India gains ground in excipients globally as manufacturers add capacity, improve compliance: Amit Raj Sinha
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Shardul Nautiyal, Mumbai
December 24 , 2025
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India is gaining ground as a reliable excipient supplier globally as Indian manufacturers are adding capacity and improving regulatory compliance. This is enabling India’s stronger participation and significant progress in regulated markets despite the fact that the industry is dominated by a few large players, states Amit Raj Sinha, MD & CEO, Sigachi Industries.
Excipients may be termed inactive, but functionally they are critical and are treated almost like active pharmaceutical ingredients (APIs) under the drug regulation. They ensure consistency, safety and performance of formulations.
Sigachi Industries focuses on building next-generation excipients with high compliance and sustainability, growing consistently at over 25% CAGR, with the ambition of building a globally reputed Indian company.
Sigachi is the market leader in MCC (microcrystalline cellulose) in India and among the top five players globally in terms of capacity and sales. MCC plays a vital role in flowability and compaction in solid oral dosage forms. It ensures uniform distribution of the active ingredient in every tablet. With solid oral dosage forms dominating due to convenience and shelf life, the global MCC market is expected to reach nearly USD 1.5 billion by 2030, growing at a CAGR of about 8%.
Sinha informs that the company’s current capacity stands at around 19,000 tons, with exports accounting for over 75% of production to more than 65 countries. With a new 12,000-ton plant in Dahej, its total cellulose-based excipient capacity will reach 31,000 tons per annum.
India is largely self-reliant in MCC. However, imports continue because global formulators are reluctant to change legacy formulations due to regulatory re-approvals. Since excipients account for only about 5% to 7% of formulation costs, there is little financial incentive to switch suppliers.
Sinha informs, “We are investing approximately Rs. 110 crore in a 12,000-ton MCC facility and Rs. 70 crore in an 1,800-ton croscarmellose sodium (CCS) disintegrant facility at Dahej SEZ. These investments strengthen our global supply capability and restore capacity lost earlier.”
He further adds, “Diversification into APIs in 2023 was a strategic move. We acquired a US FDA approved facility in Karnataka and commissioned an in-house API R&D centre in Hyderabad in July 2025. This complements our excipient business and supports long-term growth.”
Talking about company’s growth and market scenario, Sinha says, “Historically, we have grown at around 25% CAGR, and we believe this momentum will continue in generics and nutraceuticals. India’s rising importance as a formulation and ingredient exporter will support this trajectory. Our primary focus is regulated export markets, where compliance and partnerships drive leadership. Domestic growth is organic rather than strategically targeted. We have committed to delivering 25% annual top-line growth while maintaining margins and actively explore aligned acquisitions.”
Highlighting the International Pharmaceutical Excipients Council of India (IPEC)’s role, Sinha informs that the Council is doing commendable work in improving standards and compliance. However, many MSMEs hesitate to join, viewing it as a cost rather than an enabler. Currently, around 100 manufacturers are members, and increasing participation will strengthen the ecosystem.
Sinha explains, “While we are a production linked incentive (PLI) scheme beneficiary, excipients remain underrepresented. We have advocated for reintroducing a PLI scheme tailored for excipients, especially to support MSMEs. The criteria should be balanced so smaller players are not excluded and can invest in capacity and compliance.”
Environmental, Social, and Governance (ESG) is central to Sigachi Industries’ long-term vision as 75% of waste is recycled, 80% of process water reused, and it has been recognized as a ‘Great Place to Work’ for three years. It also prioritizes employee well-being and diversity.
A devastating industrial accident occurred on June 30, 2025, at the Sigachi Industries manufacturing facility in Pashamylaram, Sangareddy district, near Hyderabad, Telangana. The incident resulted in the loss of nearly 6,000 tons of capacity. “We responded by fast-tracking new capacity at Dahej (Gujarat). We are also in discussions with the Telangana government regarding our contribution to the announced compensation for affected families,” Sinha informs.
Excipients serve multiple roles, binders help in tableting, disintegrants enable tablets to break apart in the body, lubricants and glidants improve processing, and viscosity agents ensure uniform suspension in liquid formulations. Each excipient contributes to the effectiveness and reliability of the final product.
Disintegration refers to the physical breakup of a tablet in the body, which is largely driven by excipients. Dissolution is the release of the API over time and depends on both the API and excipients. Modified release profiles, such as sustained or delayed release, are designed to improve patient compliance.
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