Lannett CDMO | Lannett CDMO

For 75 years, Lannett has partnered with clients of unique NDA products which have served markets all over the world. As a CDMO, we are able to leverage our deep industry and technical knowledge and provide our clients with the ideal end-to-end solution to suit their needs.

Advanced Formulation Services

We provide cGMP clinical material and commercial products via a variety of technologies.

• Dosage forms to support PK and tox studies
• Optimization of existing formulations
• Process development and scale-up
• Excipient compatibility and dosage form design
• Improved safety and efficacy
• Reverse engineer formulation

Manufacturing Services

We specialize in Oral Solid Dose (OSD) and Liquids, including those for high potent and controlled substances. These include:

• Dry blends filled into capsules or compressed into tablets

• Dry granulation compressed into tablets

• Wet High and Low Shear granulations that are oven or fluid bed dried and filled into capsules or compressed into tablets

• Fluid bed granulations that are filled into capsules or compressed into tablets

• Wurster coated tablets

• Wurster coated beads or microtablets filled into capsules or compressed into tablets

• Non-functional and functional coated tablets

• Laser-drilled osmotic release tablets

• Tablet printing

• Immediate-release, Extended-release, and Delayed Release dosage forms using the technologies listed above

• Solution and Suspension liquid products

Fast scale-up / Supply Chain Services

• Integration of a customer´s serialization numbering system with ours.

• Utilization of quality tools such as tablet table inspection machines, serialization systems, camera systems to check lot code, expirate dates IP barcoded, and reshipper label verification.

• In-process testing every 15 and 30 minutes of each hour of a process.

• Hourly online audits on packaging. KPIs that are tracked and reported daily, weekly, and monthly.

• Automation-Electronic Logbooks, ENG/MAINT - CMMS Infor, QA/QC - LIMS, Chromeleon, Master Control.

• Validation of products/equipment/facilities.

• Supplier quality requirements and specifications.

• Testing of incoming raw materials for dispensing, manufacturing, and packaging.

• Testing of in-process and final product release, with stability testing by our Quality group.

Analytical Laboratory Services

Analytical tests

• Method development and validation
• Raw material, Packaging material, in-process and finished product release testing
• Full ICH stability finished product storage and testing
• Physicochemical testing
• Elemental Impurities
• Residual Solvents
• Extractables/Leachables

Analytical methods

• Chromatography: HPLC/UPLC with UV/RI/Conductivity/CAD, GC, TLC
• USP Dissolution Apparatus 1, 2, and 7 testing
• ICP-MS testing
• UV-VIS spectroscopy
• Atomic Absorption spectroscopy
• Particle Size testing: Sieve, Laser diffraction Total Organic Carbon (TOC) testing
• Physical Properties: Refractive Index, Specific Density, Viscosity, Polarimetry, Moisture Content

Non-sterile Microbial Tests

• Method suitability testing
• Raw material and finished product release testing
• Water Activity testing

Non-sterile Analytical Methods

• Microbiological Examination of Nonsterile Products per USP (60), (61), (62)
• Antimicrobial Effectiveness testing per USP (51)
• Water activity testing per USP (922)

Regulatory Support Services

Lannett offers end-to-end regulatory support to help simplify submissions, approvals, and overall communication with the FDA. As we are directly responsible for the manufacturing of a product, we are most prepared to provide you with all necessary documentation.

• CMC Guidance Planning and Preparation of regulatory documentation
• Post-approval product management
• ANDAs and 505(b)(2) submission guidance

Supply Chain Management, Warehousing, and Logistics Services

• DSCSA-compliant serialization services
• Domestic and global distribution
• Material sourcing VAWD accredited
• Product Identification: NDC, Batch number, Expiration date, and Serial number Product Tracing (3Ts): Transaction information, Transactional History (eASN), and Transactional statement
• Product Verification: Every item level to include aggregation

Quality Assurance

Lannett delivers reliable data, processess, and systems that are cGMP compliant and effective. Our ICH Q10 Pharmaceutical Quality System ensures that our clients receive only the best from all our teams.