About TPM Laboratories
Precision Analytical Services in the U.S. for Pharmaceutical Clients
TPM Laboratories, now part of Cormica, delivers advanced analytical testing, quality control, stability studies, and method development from its U.S. base. With deep domain knowledge, the facility supports pharmaceuticals, chemical products, and regulated industries, offering robust data to guide regulatory filing, formulation decisions, and product lifecycle assurance.
GXP Fundamentals
- Method development, validation and transfer
- QC release testing
- ICH, GMP, GLP and R&D storage stability
- physico-chemical properties
- Product safety registration
Physical / Materials Characterisation
- Particle size, shape, composition & association
- Generics support and IVBE
- X-ray diffraction
- Specialist solid state analysis
- Subvisible and visible particulate matter testing
- Nanoparticle analysis
Chemical Characterisation
- Organic impurities
- Elemental impurities
- Residual solvents
- Nitrosamine analysis
- Carbonyls analysis
Manufacturing & Commercialisation
- Cleaning validation & verification
- Occupational hygiene
- Contaminants & foreign bodies
- Contaminant migration studies
TPM Laboratories Team & Expertise
Dr. Kishore Hotha serves as General Manager of TPM Laboratories, overseeing the overall operations of safety, quality, development, and commercial functions. With over 20 years of experience across the U.S., U.K., India, and China, he has transformed regional labs into globally compliant, commercially scalable analytical platforms within CRO and CDMO environments.
His expertise spans small and large molecules, with a focus on CMC strategy and regulatory submissions. Dr. Hotha has supported 100+ IND, NDA, and ANDA filings, guided teams through multiple FDA audits, and authored over 100 scientific publications. He is widely recognized for advancing analytical excellence, regulatory compliance, and operational growth across the global pharmaceutical landscape.
Kishore Hotha
Cormica TPM General Manager
TPM Laboratories History
Founded in 2001, TPM Laboratories has evolved into a trusted U.S. contract testing organization recognized for precision, reliability, and scientific excellence. Operating from an 8,000 sq. ft. facility, TPM is equipped for high-potency API testing and licensed for controlled substances, supporting a broad range of commercial and developmental product testing programs. The site has successfully completed multiple FDA inspections with zero observations over its 24-year history, reflecting its strong commitment to quality and compliance.
In May 2024, TPM became part of the Cormica Group, expanding its U.S. presence and integrating into a global network of analytical and microbiological laboratories. Under Dr. Kishore Hotha’s leadership, TPM continues to advance its capabilities—delivering comprehensive, phase-appropriate analytical testing solutions from early development through commercialization.
Cormica's Global Locations
Trusted Testing Partner Across the Globe
With facilities in the US, UK, and EU, Cormica provides expert testing solutions to support medical device and pharmaceutical manufacturers worldwide.
