Astonea Labs Limited

Scalable business model

The company follows a customer-centric, order-driven approach focusing on optimal resource utilisation and consistent product quality. This enables it to efficiently scale operations by expanding into new domestic and international markets

Diverse product portfolio

The company offers a broad range of pharmaceutical and cosmetic products covering therapeutic areas such as antibiotics, antihistamines, diabetes, cardiovascular and gynaecological care, along with multivitamins, skin, and hair care solutions

Quality-focused service

The company emphasises timely and high-quality service through strict internal systems that minimise errors and ensure prompt delivery. This commitment has led to strong customer goodwill, high retention rates, repeat orders, and a growing client base

FDA fee non-compliance

The company has not yet satisfied its annual OTC Monograph User Fee obligation under the US FDA's program. This non-compliance renders all its OTC drug products as misbranded and bars them from interstate commerce in the US, potentially damaging its market access and reputation

Supply chain uncertainty

The company does not maintain long-term contracts with suppliers, exposing it to raw material price volatility and potential supply disruptions. Pricing is negotiated per order, increasing the risk of delays or production halts in the event of shortages or supplier exit

Regulatory compliance exposure

Operating in the tightly regulated pharmaceutical and cosmetics industries, the company is subject to stringent quality and manufacturing standards. Non-compliance with regulatory requirements across jurisdictions, including those set by the US FDA and other authorities could lead to fines, product recalls, or reputational damage