Lannett CDMO

United States North America

Lannett CDMO

Lannetts main manufacturing site sits in Seymour, Indiana, and includes capabilities for Oral Solid Dose (OSD) and Liquids.

About the plant

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.

Certifications

EMA (EU GMP)
FDA (cGMP)
Health Canada (Canada GMP)
NMPA (China GMP)
MFDS/KFDA (Republic of Korea GMP)
PMDA/MHLW (Japan GMP)

Activity

Oral liquids and semisolids, Oral solids / OSD, Bottles, Oral solutions, Oral suspensions, Oral emulsions, Syrups, Tablets, Hard capsules, Granules / Pellets, Powders, FDF / DRUG PRODUCTS manufacturing

Features

Uses: Investigational, Commercial (Phase IV), Phase II, Phase III, Human, Veterinary
Toxicity (OEB classification): 1 / low-hazard (PDE > 5,000 µg/day), 2 (PDE = 1,000 - 5,000 µg/day), 3 (PDE = 100 - 1,000 µg/day), 4 / HPAPI (PDE = 10 - 100 µg/day), 5 / HPAPI (PDE < 10 µg/day)
DEA: Schedule I (high potential for abuse / no medical use), Schedule II (high potential for abuse / medical use), Schedule III (lower potential for abuse), Schedule IV (low potential for abuse), Schedule V (lowest potential for abuse)
BSL:
Therapeutic areas: (C) Cardiovascular system, (H) Systemic hormonal preparations excl. sex hormones and insulins, (J) Antiinfectives for systemic use, (M) Musculoskeletal system, (N) Nervous system, (R) Respiratory system, (S) Sensory organs
Markets: COFEPRIS (Mexico), FDA (USA), EMA (EU), PMDA (Japan), Health Canada (Canada), MHRA (UK), NMPA (China), EDE (UAE)

Batch Size / Reactor

Small, Medium, Large

Services

Regulatory services, Development services, Manufacturing services, Analytical / QC services, Quality Assurance services, Packaging, Logistics, Preformulation studies, R&D, Formulation / Galenic design, Process development, Process optimization, Process validation, Stability studies design, Stability studies execution, ICH Stability studies, Tech transfer, Pilot plant, Formulation mixing, Research batches, Engineering batches, Scale-up, Pilot batches, Registration batches, Batch records, Analytical methods development, Analytical methods validation, Release testing of raw materials, Release testing of product, Analytical methods transfer, QP in house, Batch certification / release, GMP documentation, Parametric release, Primary packaging, Secondary packaging, Labeling, Serialization, Storage, Distribution, GDP, CMC regulatory support, NDA (New Drug Application) submission support, ANDA (Abbreviated New Drug Application) submission support

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