India-based Piramal Pharma Limited's Pharma Solutions business announced on Tuesday that it has started operations at a new production block at the firm's drug product site in Pithampur, in the state of Madhya Pradesh, India.
The new production area is called V Block and can manage batch sizes of 150 to 600 kilograms, supplementing the site's capacity to produce oral solid dosage form drug product. The Pithampur site's total production capacity increases from three billion doses to 4.5 billion doses with the addition of the new production block.
V Block includes aqueous and non-aqueous wet granulation (high shear, top spray and bottom spray); direct, mono, and bilayer compression; aqueous and non-aqueous coating; and bottle packaging technologies. Aggregation capabilities related to US FDA e-pedigree and track and trace requirements are proposed for V Block, as is the addition of dry granulation capabilities (roller compaction). The new production block offers dedicated personnel and material entry with biometric access control for the block and the operating cubicles within it, and an air handling unit for each cubicle.
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion