Research & Development

XL houses a dedicated research lab for formulation development and optimization. The Research lab is equipped with pilot scale machinery of all production machines available. An analytical research lab is attached to research lab for developmental testing / analytical method development and validations. A separate stability study area for formulation research lab is provided.

For many years, XL has been putting great emphasis on the development of new formulations and the R&D Department deserves a lot of credit for the fact that XL has become one of the fast growing pharmaceutical manufacturing & exporting companies focusing on new generic drugs. Our team continuously expands their scientific and technological knowledge with the objective of placing on the market safe and effective drugs with clear benefits for patients. Thanks to our integrated development and manufacturing, we are able to design, manufacture and distribute high-quality medicinal products that facilitate patient’s access to affordable and high quality healthcare.

Our goal is to provide cost-effective and innovative treatment options to address society's medical needs. This has prompted us to develop products that have a distinct edge over existing products in the market. We have the capability to deliver quality products within established timelines, at low costs and without compromising on quality.

Creative teams from R&D and business development generate innovative concepts and ideas which are aligned to synergies across therapeutic areas and business needs. The focus of R&D is on quality product development, keeping in view safety and efficacy of drugs on target populations.
Our capabilities lie in developing innovative, safe, environment-friendly and cost effective global technologies to deliver high quality products.

Manufacturing Plant

XL's manufacturing division works tirelessly to ensure a stable and high quality product. Manufacturing site safety and protection of the environment are of paramount considerations.

XL's state-of-the-art facilities are equipped with machinery based on robust principles infusing modern technology to bring out accurate results with faster and increased production capacities. As quality assurance measure, procedures are adopted to minimize human touch to the products which in turn prevents contamination.

The production of all formulations is carried out in controlled environmental conditions of temperature, light & RH, wherever necessary, under Class 100,000 through HEPA filters having an efficiency of 99.997% to filter out particles as small as 0.3 micron. Annual Capacities:

1 billion tablets
800 million capsules (Hard Gelatin)
150 million capsules (Soft gelatin)
30 million sachets
150 kl oral liquids

We continually strive for excellence in infrastructure and technology. We have successfully implemented automation in various manufacturing processes to improve quality compliance and productivity.

Quality Control

The In-Process Quality Control & Assurance (IPQC & A) plays an important role in the manufacturing process as it continuously monitors all production processes at every stage for the accuracy to be brought out in the products. Frequent quality parameter checks are conducted to ensure a perfect product. Quality Control Lab forms the heart of our manufacturing facilities and plays a vital role in regulating the quality of products.

XL has an in-house fully equipped laboratory to carry out analysis of API's, Excipients & Packing Material by physical, microbiological, instrumental & chemical testing and effective process control. A Separate Sophisticated Instrument Lab is set up at XL having HPLC's Atomic Absorption Spectrophotometer, FTIR, UV Spectrophotometer and TOC Analyser. Instrument calibration and validation is a routine feature at XL to ensure accurate analysis results. Accelerated & Real Time Stability Studies are undertaken at XL for different climatic zones as per the ICH & WHO guidelines.

Online rejection of faulty blisters by Camera Inspection Systems is an added feature to the packing machines to ensure quality and quantity before delivery.

Regulatory Affairs

The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the inter phase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.

In XL, Regulatory Department is involved in the development of new medicinal products from early by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities. Regulatory Department is actively involved in every stage of development of a new medicine and in the post-marketing activities with authorized medicinal products.

In XL, Regulatory Affairs professionals play a key role in guiding drug development strategy in an increasingly global environment. But they also play an important operational role by considering the best processes to follow and enabling structured interaction with regulatory authorities.

Our regulatory team ensures that the information and data to be conveyed and discussed with the regulatory bodies are presented in the right way and form. They develop the regulatory strategy, arrange agency meetings, prepare and compile the questions and briefing documents.

XL Automation