Lannett Company - CDMO/CMO

Drug Development and Manufacturing Expertise: Offering comprehensive services in drug development, from initial research and development to full-scale manufacturing. This includes CDMO services and CMO manufacturing, ensuring a seamless transition from concept to market.

Scalability Solutions: Assisting in scaling production from laboratory to commercial scale, meeting the demands of various projects while maintaining quality and efficiency. This is where the expertise of a full-service CDMO becomes invaluable.

Regulatory Compliance and Quality Assurance: Ensuring adherence to strict regulatory standards such as FDA and EMA guidelines, and implementing rigorous quality control measures throughout the manufacturing process. This includes operating within GMP certified facilities to guarantee the highest standards of production.

Cost-Effective Production: Providing efficient and cost-effective solutions for the production of medical and pharmaceutical products, enabling companies to focus on innovation and marketing. CMO contract manufacturing plays a key role in this aspect.

End-to-End Service Provision: From concept to commercialization, CMOs/CDMOs offer a range of services including process optimization, formulation development, clinical trial material production, and commercial manufacturing. This comprehensive approach is often referred to as Contract Development Manufacturing.

Advanced Analytical Techniques: Utilization of sophisticated methods such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography-Mass Spectrometry (GC-MS), and various spectroscopy techniques for accurate drug analysis. This is a cornerstone of services offered by analytical testing laboratories and Pharma Laboratories.

Regulatory Compliance: Ensuring that all analytical testing and processes meet the stringent guidelines set by regulatory bodies like the FDA and EMA. This includes GMP analytical testing, which is crucial for maintaining high standards in pharmaceutical analysis.

Quality Control and Assurance: Critical role in quality control and assurance, verifying the composition, purity, and potency of pharmaceutical products. Analytical Laboratory Services play a pivotal role in this process.

Support in Drug Development: Providing essential support in the drug development process, from early discovery through to clinical trials and commercialization. This includes chemical analytical services that are vital for comprehensive pharmaceutical research.

Informed Decision-Making: Aiding pharmaceutical companies in making informed decisions through comprehensive data and analysis provided by Pharmaceutical Analysis services.

Diverse Dosage Form Production: Expertise in creating a wide array of finished dosage forms, including tablets, capsules, oral liquids, powders, and more. This service is a critical aspect of FDF CDMO offerings.

High-Quality Formulation Development: Developing formulations that ensure efficacy, stability, and patient acceptability, adhering to precise pharmaceutical standards. This includes specialized formulation services and CDMO formulation development.

Advanced Manufacturing Processes: Utilizing state-of-the-art manufacturing processes and equipment to produce high-quality finished pharmaceutical products. This is a key component of CDMO products and contract formulation services.

Regulatory Compliance and Quality Assurance: Ensuring all products meet stringent regulatory standards, including compliance with FDA, EMA, and other regulatory bodies’ guidelines.

Customized Manufacturing Solutions: Offering tailored solutions to meet the unique needs of different pharmaceutical products, from small-scale batches to large-scale commercial production. This flexibility is essential in the realm of FDF manufacturing.

Granulation and Compression: Expertise in granulation processes to prepare powder for compression, and precision in tablet compression to ensure uniformity and dosage accuracy. This is a critical aspect of solid dose manufacturing.

Advanced Coating Techniques: Application of various coating techniques to enhance tablet stability, modify drug release, and improve patient acceptability. This is essential in tablet formulation.

Consistent Drug Release Profiles: Development of tablets with controlled release profiles, ensuring consistent therapeutic effects and patient compliance.

Custom Tablet Formulations: Capability to create customized tablet formulations, addressing a wide range of therapeutic areas from pain management to chronic disease treatment. This is a key service offered by tablet manufacturing companies.

Quality Assurance and Regulatory Compliance: Strict adherence to quality standards and regulatory guidelines, ensuring the safety and efficacy of tablet products. This includes adherence to GMP standards in tablet CDMO services.

Homogeneous Formulations: Ensuring consistent homogeneity in oral liquid formulations for uniform dosing and efficacy. This is a key aspect of oral liquids CDMO services.

Enhanced Palatability: Development of oral liquids with improved taste and texture to enhance patient compliance, particularly crucial in pediatric care. This is essential in liquid pharmaceutical manufacturing.

Stability and Shelf-Life: Focusing on the stability of formulations to ensure the longevity and effectiveness of oral liquids over time.

Precise Dosing Solutions: Offering solutions that allow for precise and adjustable dosing, accommodating different patient needs and treatment regimens. This is a critical service in liquid contract manufacturing.

Wide Therapeutic Range: Production capabilities spanning a diverse range of therapeutic categories to address various health conditions with oral liquid formulations. This includes Oral Solids manufacturing capabilities.