Piramal Pharma Limited Plot 67-70, sector II Pithampur, Indore, Madhya Pradesh 454775 (India)
The Pithampur site provides clinical, pilot, and commercial-scale manufacturing of oral solid dosage (OSD) forms and packaging services to the Americas, Europe, and Australia. Major regulatory accreditations include USFDA, EU GMP, Brazil Anvisa, TGA Australia, and FIMEA Finland.
The Pithampur facility provides commercial manufacturing services for tablets and capsules through 3 different blocks. The site currently has a total OSD capacity of 4.5 billion units/year.
We have a strong track record in executing exhibit and validation batches to develop robust processes and support bioequivalence studies. We also manufacture placebos matching the drug product for clinical trials.
Our analytical labs feature the latest equipment that allows us to conduct 99.5% of all testing in-house. We have segregated wet, instrument and microbiology labs and can conduct stability studies for all markets as per ICH requirements.
The Pithampur facility features a cGMP warehouse with various temperature controlled capabilities for sensitive compounds. We use a bar-code system for inventory management to enhance traceability.
The Pithampur facility provides commercial manufacturing services for tablets and capsules through 3 different blocks. The site currently has a total OSD capacity of 4.5 billion units/year.
We have a strong track record in executing exhibit and validation batches to develop robust processes and support bioequivalence studies. We also manufacture placebos matching the drug product for clinical trials.
Our analytical labs feature the latest equipment that allows us to conduct 99.5% of all testing in-house. We have segregated wet, instrument and microbiology labs and can conduct stability studies for all markets as per ICH requirements.
The Pithampur facility features a cGMP warehouse with various temperature controlled capabilities for sensitive compounds. We use a bar-code system for inventory management to enhance traceability.
Our oral solid capabilities include immediate and modified release tablets, aqueous and solvent granulation and film coating and hard gelatin capsule filling. We can manufacture batch sizes ranging from 4kg to 600kg along with bottle, bulk and blister packaging with autocartonator.
The team at Pithampur is experienced in a number of technologies like direct compression granulation, wet granulation and top spray granulation (aqueous and non-aqueous), roller compaction, single and bilayer compression, Wurster coating (aqueous and non-aqueous), and tamping-based capsule filling. Our dedicated ophthalmics block features both blow fill seal and form fill seal technologies.
The site has a state-of-the-art low humidity manufacturing block for any formulations which need low humidity manufacturing like enzymatic tablets.
Pithampur can be a cost-effective end-to-end solution via backward integration with our API site in Digwal. It is also deeply integrated with our formulations R&D site in Ahmedabad, providing expert guidance at all stages.
Pithampur has an excellent track record in both Tech Transfer (Phase III CTA to exhibit/registration for ANDA, NDA &505b2 followed by commercial) and Site Transfer (transferring commercial products from client sites).
Pithampur has an impressive record of delivering on time in full, consistently exceeding client expectations. The site is capable of handling the entire supply chain, from procurement to vendor negotiation, displaying unparalleled efficiency and speed.
Embracing a culture of quality, we integrate rigorous quality checks 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.
Pithampur was inaugurated as Piramal’s first Greenfield project. Tablet ‘O’ block and ophthalmic block was established
Increased OSD capacity with the opening of ‘N’ block. Ampoule and vial capacity was enhanced
‘O’ block was upgraded and tablets ‘M’ block underwent expansion. FFS block was also upgraded
Upgradation of pilot plant (‘P’ block) and ‘N’ block
Enhanced bottle packaging capacity and upgraded the ‘P’ block
Upgradation of stability block and utility service, with warehouse expansion
‘V’ block was added, along with numerous upgrades to microbiology and QC labs, warehouse. Roller compaction granulation was added
