Piramal Pharma Limited - Development Services, Plot #19 Pharmaceutical Special Economic Zone, Ahmedabad, Gujarat 382 213 (India)
Our Ahmedabad facility is a Centre of Excellence for formulation development and clinical batch manufacturing of oral solid dosage forms. It has been accredited by regulatory organizations like MPA Sweden, Fimea Finland, and USFDA, among others, and is also ISO-14001 and 45001 compliant.
The site offers pre formulation and formulation development services for NCEs, Generics, Complex Generics, 505(b)2 products, Generics- 501B1 and 505B2 that fall in Oral Solid Dosage forms (OSD). With the team of over 150 scientists proficient in a large range of oral solid dosage forms, we are well-suited to deal with any challenges arising in your drug development process.
The Ahmedabad facility has capability to support manufacturing ranging from development scale to clinical manufacturing (50g to 50Kg), making it the perfect partner for Phase I/II supply. Our team’s agility and flexibility allows us to accelerate timelines while maintaining the highest quality standards.
We have a robust track record in executing tech transfer projects, both within our network and to client preferred sites. Our technology transfer teams ensure smooth scale-up and transfer for commercial manufacturing.
Our highly experienced team and state-of-the art equipment enables us to provide comprehensive support for method development, validation, stability studies, microbiological testing and extractables and leachables studies.
The site offers pre formulation and formulation development services for NCEs, Generics, Complex Generics, 505(b)2 products, Generics- 501B1 and 505B2 that fall in Oral Solid Dosage forms (OSD). With the team of over 150 scientists proficient in a large range of oral solid dosage forms, we are well-suited to deal with any challenges arising in your drug development process.
The Ahmedabad facility has capability to support manufacturing ranging from development scale to clinical manufacturing (50g to 50Kg), making it the perfect partner for Phase I/II supply. Our team’s agility and flexibility allows us to accelerate timelines while maintaining the highest quality standards.
We have a robust track record in executing tech transfer projects, both within our network and to client preferred sites. Our technology transfer teams ensure smooth scale-up and transfer for commercial manufacturing.
Our highly experienced team and state-of-the art equipment enables us to provide comprehensive support for method development, validation, stability studies, microbiological testing and extractables and leachables studies.
The team at PPDS has all-embracing experience in developing and manufacturing oral dosage forms &ndash Immediate release and Modified release bilayer tablets, Mini tablets, Tablets in capsule, MUPS tablets and capsules, among others. Team is also experience in developing oral liquids such as oral solutions and suspensions. Coupled with our state-of-the-art equipment such as Hot Melt Extrusion (HME) and Nano Mill, it makes us well-equipped to solve all your solubility/ bioavailability challenges.
The site can handle high potent compounds with OEL down to 1µg/m 3.
We offer services such as material CoA evaluation, AET determination, controlled solvent extraction studies, screening & identification, extractable qualification & validation, and leachable studies. Our facility comprises of high end equipments such as GCMS, ICP-MS and HRMS and technical leadership to provide solutions.
Our Ahmedabad facility offers a wide array of solid-state characterization studies, including PXRD, TGA, DSC, Polarized Light Microscope (PLM), Dynamic Vapor Sorption (DVS/Hygroscopicity), and Particle Size Analysis (PSA). We have well-qualified scientific experts who can perform, interpret, and comprehend data meaningfully to structure it into useful information, enabling decision-making.
We are equipped with advanced instruments, including HRMS and GCMS, which allow us to perform impurity profiling and identify and characterize genotoxic impurities, including nitrosamines and elemental impurities. The team has strong chemistry knowledge and experience performing structure elucidation with degradation pathways.
At Piramal Pharma's PPDS facility, the Accelerated Stability Assessment Program (ASAP) leverages the ASAPprime® software to accurately predict the shelf life of pharmaceutical products in a short period as compared to time required by conventional methods. This capability enables 21-day exposure of samples to a combination of varying temperature and relative humidity conditions, analysing them and predicting shelf life after feeding data into software. This shortened stability program allows quick evaluation shelf life of product which is very critical in the early clinical development phase. The data generated and predicted shelf-life is accepted by regulatory agencies.
The PPDS facility employs advanced micro-dosing systems clinical trials. API can be accurately filled into capsules of desired sizes. This capability avoids the complex process of formulation development, its stability study and more importantly avoids interference of excipients in accessing pharmacokinetic profile of the molecule which is targeted for first-in-human trials. With a capability of accurately filling 600 capsule per hour it shortens the time required for clinical trial readiness.
Piramal Pharma's PPDS facility utilizes cutting-edge spray drying technology to enhance solubility for poorly soluble drugs (BCS Class II/IV). The process is particularly suited for producing stable amorphous solid dispersions of APIs and managing heat-sensitive compounds. With a focus on safe solvent handling, precise process regulation, and programmable operations, the spray dryer accelerates formulation optimization and simplifies the scale-up process for drug manufacturing. Best suitable for molecules that require solubility enhancements to improve their pharmacokinetic profile.
We specialize in the development of various complex formulations, including modified-release and fixed-dose combinations, while ensuring scalability, speed, and flexibility throughout the development process.
We offer seamless integration that covers everything from procurement of API to formulation development and clinical & commercial batch manufacturing.
We have successfully developed over 300 products and executed more than 35 tech transfers at Piramal or other client-preferred sites.
Located in a pharmaceutical Special Economic Zone (SEZ), our Ahmedabad site offers tax and import duty benefits.
Inauguration of the Site
Site Expansion with New F&D Lab, Analytical Lab, Warehouse and New Seating Space
Equipment Installation for Solid State Characterization
Addition of Bioavailability Enhancement Capabilities (HME and Nano Mill). Pilot Plant Expansion from 11 to 14 Processing Units. Addition of Sachet Filling Machine.
