Dr. RGSV Prasad

Director

Finished Dosage Formulations (FDF) manufacturers in India are key players in the global pharmaceutical industry, providing essential medicines in their final consumable form. Renowned for cost-efficiency, technological advancements, and stringent quality standards, Indian FDF manufacturers ensure access to affordable, high-quality medications worldwide. Their expertise in large-scale production and compliance with international regulatory standards strengthens India's position as a leading exporter in the pharmaceutical sector, meeting global demand while driving innovation and healthcare advancements.

LN Laboratories is one such dynamic leader in this space founded in 2020 with a mission to enhance finished dosage forms through proprietary technological platforms, global infrastructure, and a robust quality system. The company is revolutionizing healthcare with its innovative Thin Film technology, significantly improving global accessibility to advanced, patient-friendly treatments.

LN Laboratories integrates patient-centric approaches in the development of new dosage forms, focusing on userfriendliness and effectiveness. The firm ensures compliance with bioequivalence standards as per Indian, European, and U.S. regulations. Customer expectations are met through strict adherence to three core principles: maintaining the highest product quality, conducting extensive research and development, and ensuring reliability. These pillars drive customer trust and loyalty, positioning LN Laboratories as a leader in this space.

Balancing affordability and quality is central to LN Laboratories' product development. The company carefully selects cost-effective ingredients without compromising on quality or regulatory approvals. By adhering to stringent guidelines, such as those from the FDA and other drug control bodies, the firm maintains high standards. Although the rising costs of manufacturing can impact patient compliance, LN Laboratories strives to optimize operational efficiencies to deliver affordable yet high-quality products.

LN Laboratories addresses the needs of bedridden and non-compliant patients, particularly those with dysphagia, by developing innovative oral thin film dosage forms. These films dissolve on the tongue and are absorbed through saliva, eliminating the need for swallowing pills—a significant challenge for patients with difficulty swallowing, such as those with oral cancer undergoing radiation or chemotherapy. The dosage form is also ideal for children who are resistant to taking traditional medications. By providing a more palatable and convenient option, LN Laboratories enhances patient compliance, ensuring that patients receive the full therapeutic benefits of their prescribed treatments.

“Developing our products in India offers several advantages, including cost-effective manufacturing, abundant resources, and a skilled workforce. The large population provides us with significant market opportunities. Our primary goal is to create indigenous, highquality products tailored for Indian consumers, reducing dependence on outsourced pharmaceuticals. By focusing on affordability and quality, we ensure that our offerings are accessible to a broader audience while maintaining the standards required for global reach”, adds Dr. RGSV Prasad, Director.

Navigating the Challenges

LN Laboratories faces several regulatory challenges in bringing innovative oral thin film dosage forms to global markets. As this is an emerging technology, not all products can be converted to oral thin films, and there are dosage limitations. One key challenge is achieving product equivalency, as many existing products are only available in tablet or capsule form, making it difficult to match their bioequivalence. Additionally, meeting regulatory compliance standards poses a significant hurdle. However, LN Laboratories has successfully navigated these challenges for several products, achieving regulatory approval by demonstrating equivalency and adhering to stringent compliance requirements.

Over the past four years, LN Laboratories has filed 18 patents related to oral thin film technology, with eight patents already granted. As an innovation leader, the company is awaiting legal clearances for additional patents and is committed to bringing these cutting-edge products to market, further advancing its role in the pharmaceutical industry.

“One of the key challenges we face with traditional dosage forms like tablets and capsules is addressing taste and palatability. Tablets and capsules often lack taste, but we must mask the active ingredients’ taste to ensure patient comfort. Another challenge is shifting patients from conventional dosage forms to oral thin films. Since people are accustomed to tablets and capsules, educating them about the benefits of thin films can be difficult. However, we focus on developing palatable, effective solutions to overcome these obstacles and enhance patient adherence”, emphasizes Dr. RGSV Prasad, Director.

Expanding Horizons

LN Laboratories, founded in 2019-2020 during the COVID-19 pandemic, faced early challenges in securing government land and establishing its R&D facility. Despite these obstacles, the company has grown steadily, focusing 80 percent of its efforts on oral thin film technology. Over the past four years, LN Laboratories has distinguished itself through its rigorous quality policy and innovation. The company has filed 18-20 unique patents, eight of which have already been granted, giving it a competitive edge in the market. In addition to oral thin films, LN Laboratories is expanding into medical devices, diversifying beyond conventional dosage forms.

The company boasts an extensive presence in Hyderabad, with an R&D, pilot, and large-scale production facility, including Asia's largest thin-film manufacturing site in Genome Valley. Looking ahead, future plans include expanding into Asiapacific, GCC and UAE markets to strengthen its global presence. A flagship product, a folic acid supplement for pregnant women, has been well-received for effectively boosting folic acid levels, and the company aims to revolutionize folic acid treatment through its innovative film technology.