Shilpa Medicare Limited , a leading Indian pharmaceutical company, has announced a strategic investment in the US-based biotech startup Alveolus Bio, signaling a significant move in the development of innovative lung disease therapies.

Investment Details

Shilpa Pharma Inc, a wholly-owned subsidiary of Shilpa Medicare Limited, has agreed to invest US$2.00 million in SAFE (Simple Agreement for Future Equity) Notes in Alveolus Bio. This investment will convert to shares at a later stage, with the shareholding percentage dependent on future valuation conditions.

Strategic Partnership

Under this strategic engagement, Shilpa Biologics Private Limited, another wholly-owned subsidiary of Shilpa Medicare, will serve as the exclusive global development and manufacturing partner for Alveolus Bio. This partnership aims to combine Shilpa's expertise in turnkey biologics development, process optimization, and manufacturing with Alveolus Bio's cutting-edge resMIT platform.

About Alveolus Bio

Alveolus Bio, incorporated in 2021, is pioneering breakthrough therapeutic assets for lung diseases through its proprietary resMIT platform. The company's pipeline includes preclinical phase live biotherapeutics for various lung conditions, including:

• Chronic Obstructive Pulmonary Disease (COPD)
• Bronchopulmonary Dysplasia (BPD)
• Pulmonary Fibrosis
• Lung Injury Secondary to Viral Infection
• Neutrophilic Asthma

The company also has earlier-stage programs targeting Cystic Fibrosis (CF), Pulmonary Arterial Hypertension (PAH), and Acute Respiratory Distress Syndrome.

Financial Performance

Alveolus Bio has shown impressive growth in its income over the past three years:

Investment Objectives

The investment from Shilpa Medicare is expected to fund Alveolus Bio's lead COPD program through Phase 2 clinical trials and accelerate additional preclinical programs. This collaboration also creates a platform for co-development and future manufacturing partnerships, potentially leveraging India's competitive biologics manufacturing ecosystem for global clinical and commercial supply.

Management Perspectives

Vishnukant Bhutada, Managing Director of Shilpa Medicare Limited, stated, "This partnership with Alveolus Bio not only strengthens our innovation pipeline but also positions Shilpa as a key global partner for biotech companies looking to translate bold science into scalable clinical and commercial solutions."

Gaurav Mehta, CEO of Alveolus Bio, added, "This partnership with Shilpa Medicare is not just about funding—it's about combining deep biotech innovation with proven pharmaceutical execution. Together, we can deliver these life-changing therapies to patients much faster and more efficiently."

Completion Timeline

The investment is expected to be completed within one month of signing the definitive agreements.

This strategic move aligns with Shilpa Medicare's strategy to expand its biologics footprint, diversify into innovative therapeutic platforms, and build strategic alliances with disruptive biotech companies globally. The collaboration reinforces India's growing role in global biotech innovation and positions both companies to make significant advancements in the treatment of chronic and life-threatening lung diseases.

Shilpa Medicare Limited has announced a significant development in its regulatory compliance efforts. The company has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Unit VI located in Bengaluru, indicating the successful completion of a recent inspection.

EIR Details

According to the company's disclosure to the stock exchanges, the EIR comes with a Voluntary Action Indicated (VAI) classification. This classification suggests that while the FDA found some objectionable conditions, they were not significant enough to warrant regulatory action, and the company can address them voluntarily.

Inspection and Facility Capabilities

The USFDA conducted a Good Manufacturing Practice (GMP) inspection of Unit VI from October 24 to 30. This facility, located in Dabaspet, Bengaluru, Karnataka, is specialized in the manufacturing, packaging, testing, storage, and distribution of two types of complex dosage forms:

1. Oral Dissolving Films
2. Transdermal Systems

Regulatory Approvals and Market Presence

Shilpa Medicare's Unit VI has already secured approvals from several international regulatory bodies, including:

• European Medicines Agency (EMA), Europe
• Medicines and Healthcare products Regulatory Agency (MHRA), UK
• Saudi Food and Drug Authority (SFDA), Saudi Arabia
• Therapeutic Goods Administration (TGA), Australia

The company is currently supplying Oral Film products to the US market and other international markets. Additionally, Shilpa Medicare has filed for approval of its Transdermal products in the European market, indicating its strategy for global expansion in complex drug delivery systems.

Implications for Shilpa Medicare

The receipt of the EIR with a VAI classification from the USFDA is a positive development for Shilpa Medicare. It demonstrates the company's commitment to maintaining high-quality manufacturing standards and compliance with international regulatory requirements. This approval could potentially strengthen Shilpa Medicare's position in the global pharmaceutical market, particularly in the United States, for its specialized drug delivery systems.

As Shilpa Medicare continues to expand its presence in complex dosage forms, the successful USFDA inspection of Unit VI may open up new opportunities for the company in the highly regulated US pharmaceutical market.