Pharmazell Finished Dosage Form

In order to read it, Adobe Acrobat Reader X will be required. It can be downloaded free of charge at
http://get.adobe.com/de/reader/

PharmaZell (Vizag) operates a pilot plant for formulations to

• Ensure technology transfer from Lab development to Pilot/ Pivotal scale up, inline simulation to commercial scale production
• Produce formulations Exhibit/ Submission/ Pivotal batches under cGMP for BA/BE studies
• Conduct stability studies as per the ICH and regulatory requirements
• manufacture small scale commercial batches (high value products, which are usually required in small batch sizes).

We contribute a scale-up experience which guarantees the process optimization as per all regulatory guidelines with all safety and efficiency aspects.

Key characteristics of Pilot/Pivotal Plant

• The Facility is a class 1,000,000 area with a cGMP compliant documentation and equipment
• Separate well-equipped and demarcated rooms as material hold area, granulation area, compression room, a coating room, IPQC room, primary and secondary packaging room and wash area.
• Capable of taking up batch size up to 15 kg to 75 kg.
• Capable of wet/dry granulation, direct compression, film coating and blister/strip/alu-alu packing of oral solid dosage finished products.
• Analytical method validations.
• Validation studies for Pilot/ Pivotal
• Dossier registration support to all regulated and ROW markets

• Product launch after patent expiry
• Absolute focus on Safety, Health & Environment
• Having space for new/ novel drug delivery systems like technology platforms (modifier release, delayed release, dry syrups)