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
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.
Our facility supports Phase I-III and commercial supplies of API, RSMs, KSMs, and intermediates, with over 784kL total capacity across 266 reactors (10L-15,000L). The site also has a specialized hydrogenation facility with 6 reactors (25L-4,000L) operating up to 40 bar pressure.
Developing, optimizing, and validating robust processes for NCEs, RSMs/KSMs, intermediates, and APIs.
Developing, qualifying, validating, and conducting stability studies for analytical methods.
Proven history of backing complex chemistries and offering analytical services, along with dedication to continuous process improvement for our strategic partners.
Ability to support your drug candidate through its discovery > clinical development > commercialization.
Flexibility to expand & back-integrate KSM/RSM and API to meet your manufacturing needs.
Embracing a culture of quality, we integrate rigorous quality checks and balances throughout our operations, ensuring consistent and exceptional product quality. Our teams are dedicated to upholding the highest quality standards at all stages of the development process.
Greenfield Project (Blocks A,B,C & D operational)
Upgraded and expanded adding 2 New blocks (E & F)
Expanded to add 1 new block and QA & QC building
Expanded to add H Block
Expanded to add multiple new blocks and Kilo lab
Expansion of Quality building
Expanded to add a new FG warehouse
