LLM Information

Piramal Pharma Solutions

Directory listing
Pharmaceuticals 📍 Lexington, KY Est. 2015

Directory record status

These labels describe this UNITEMFG record. They do not guarantee current capabilities, certifications, capacity, quality, or fit for a specific job.

Directory listing
Listed
Ownership
Unclaimed
Evidence reviewed
Not recorded
Last evidence review
Not recorded

About

Piramal Pharma Solutions operates as a leading global contract development and manufacturing organization headquartered in Mumbai, India with significant operations in Lexington, Kentucky. The company serves as a comprehensive pharmaceutical partner, delivering end-to-end services across the entire drug development lifecycle from discovery through commercial manufacturing. The organization specializes in advanced drug substance manufacturing, including high-potency APIs, peptides, hormonal compounds, and controlled substances. Their drug product capabilities encompass diverse dosage forms including oral solids, liquids, topical formulations, and sterile injectables. Piramal Pharma Solutions has established particular expertise in complex therapeutic areas such as antibody drug conjugates, vaccines, and biologics manufacturing. With over 4,700 team members across 15 global manufacturing sites, the company has successfully completed more than 125 integrated projects since 2020. Their commitment to quality governance is demonstrated through 365-plus successful regulatory inspections and partnerships with over 500 customers worldwide. The Lexington facility contributes to this global network by providing specialized pharmaceutical manufacturing and development services. Piramal Pharma Solutions differentiates itself through patient-centric innovation and integrated global solutions that accelerate drug development timelines. Their comprehensive service portfolio enables pharmaceutical companies to advance critical therapies from concept to market, supporting improved patient outcomes through reliable, high-quality manufacturing partnerships and scientific expertise.

Specialties

Sterile Liquid InjectablesLyophilized PharmaceuticalsLiposomal Drug FormulationsNano-Emulsion ProductsAntibody-Drug Conjugates

Manufacturing Capabilities

Processes

Sterile ManufacturingLyophilizationAseptic ProcessingAnalytical Testing

Materials

Active Pharmaceutical IngredientsExcipientsSterile SolutionsBiologics

Certifications & Quality

Business Certifications

USFDAPMDATFDAISO StandardsGMP

Source-backed capabilities

These capability statements were observed in the linked manufacturer sources. They are source evidence, not a certification of the company or its current capacity.

Certification

  • GMP

    s NEWS & MEDIA add close In The News Press Releases Awards EVENTS SUSTAINABILITY PATIENT CENTRICITY CAREERS CONTACT US Drug Discovery add close Integrated Drug Discovery Services Synthetic Chemistry In Vitro Biology Analytical Support Services DMPK (In-Vitro ADME/ In-Vivo PK) Non-GMP Kilo Lab Service Drug Substance add close API Development Route Scouting Process and analytical Development Pre-GMP Scale-up API Manufacturing Pre-Clinical Supply Clinical Supply Commercial Supply Scale-Up and Tech

  • PMDA

    ral HPAPIs from early development to commercial manufacture, solidifying its position as a global leader in API and HPAPI development, as well as GMP manufacturing for complex NCEs. The site has been fully inspected by numerous regulatory agencies, including USFDA, Health Canada, PMDA Japan, COFEPRIS Mexico, MFDS Korea, TGA Australia, and the Russian Ministry of Health. Riverview Drug Substance Development & Manufacturing EXPLORE Piramal’s Turbhe facility offers strong expertise in the dev

  • USFDA

    submission of DMFs and MAAs (USA, EU, Canada, ROW countries). Our track record includes over 160 DMFs filed in various regions like USA, Canada, EU, Japan, China, Brazil, Korea and other countries. It also includes more than 20 CEPs filed with EDQM. More than 30 ANDAs filed with USFDA and a significant no. of approvals. We excel in the preparation of regulatory strategies, extension of approved dossiers to various other markets, lifecycle management of drug substances and products, artwork prep

Location

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Lexington, KY •••••