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Piramal Pharma Limited, Digwal Village, Kohir Mandal, Sangareddy District, Telangana 502321, India
Piramal’s Digwal facility offers services for developing and commercial manufacturing of APIs (NCEs & Generics) and key intermediates. This facility has three manufacturing areas with 12+ multi-purpose production blocks. It has a total volumetric capacity of over 750 kL, housing 245 reactors. The facility has received regulatory accreditations from USFDA, EDQM, AIFA, and KFDA.
This facility offers services for process and route selection and develops processes for GMP scale-up. It can also manufacture GMP batches ranging from grams to hundreds of kilograms
The facility offers custom synthesis capabilities including heterocyclic synthesis with enzyme-assisted kinetic resolution, heterogeneous catalysis (Pd/C, Pt/C, Pt/ Al2O3), metal hydride reduction, borane chemistry, stereo-selective synthesis, and troubleshooting in plant operations. It also covers common chemistries such as esterification, cyclizations, and protection/de-protection reactions.
Identifying and selecting IP-compliant, cost-effective, commercially viable, safe, and environmentally friendly routes for NCEs and Generic APIs.
Developing, optimizing, and validating robust processes for NCEs, RSMs/KSMs, intermediates, and APIs.
Developing, qualifying, validating, and conducting stability studies for analytical methods.