Ahmedabad (Development Services)

Ahmedabad, India site was established in 2009. It is a MPA, Sweden approved and FDA approvable facility for development and manufacturing of GMP batches of solid oral dosage form. It is a center of excellence for solid dosage forms and pediatric formulation.

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Services Offered

  • Pre-formulation
  • Formulation development
  • Analytical method development and validation
  • Manufacture of scale-up / Clinical batches
  • Bulk Packing of batches
  • Formulation and Analytical Technology transfer
  • Stand alone stability studies

Site capabilities

  • Supports development to Clinical manufacturing (50 g to 35 kg)
  • Capability to handle Low RH compounds handling (<30%)
  • High-potency compounds (OEL: 1 mcg/cu.m)
  • Multi-particulates (GPCG 2 and 30)
  • Roller compaction
  • Bilayer Compression Machine (Korsch single layer & Cadmach for single & bilayer)
  • Specialized IPQC tools such as Geopyc, Shulze Ring-shear tester for powder / compacts evaluation, sifting & fluidization type segregation testers

Special Features

  • Dosage forms being handled are Oral Solids like, Tablets, Capsules, Powder in bottles, Blinded comparators, etc.
  • Located in the – Pharmaceutical Special Economic Zone (SEZ)
  • It is accredited with ISO-14001 & OHSAS-18001, QP certification (EU) , cGMP/cGLP compliant, Local FDA
  • Explosion-proof area for handling non-aqueous solvents
  • Design of experiments using Statistica software
  • Site has been validated to handle compounds up to OEL of 1 mcg/cu.m
  • Program manager has a 360° view of the project and is the "go-to" person for all project related issues – at all times

Contact Details

Piramal Enterprises Limited - Development Services

Plot # 19 Pharmaceutical Special Economic Zone,

Village Matoda, Sarkhej-Bawla NH #8A, Taluka Sanand,

Dist. Ahmedabad, Gujarat 382 213

Contact No: +91-2717 669100/110

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