Formulation Development - Mumbai

Operational since 2005, our Mumbai site is fully equipped for development of all liquid dosage forms both Sterile and Non-sterile and high potent solid oral dosage forms.

Service Offered:

  • Pre formulation
  • Formulation Development
    • Parental Products: Simple and Complex Injectable 
    • Opthalmic Formulations
    • Solid oral Formulation (for High potent API) 
    • Liquid Formulation
    • Semisolid Formulations
  • Analytical Dev / Validation
    • Analytical method development, verification & validation 
    • Extractable and Leachable study 
    • Cleaning validations 
    • Packing material testing
  • Microbiological Tests
    • Environment monitoring of classified areas 
    • Isolation and Identification of Culture using Biomereiux API Kit
    • Preservative efficacy testing 
    • Microbiological method development for API/Excipient/Formulations
    • Test for sterility 
    • Test for bacterial Endotoxin
  • Stability Studies
    • Complete stability studies as per ICH guidelines (inclusive of Zone IV-A & IVB)

Equipment Technology:

  • Preformulation:
    • Differential scanning calorimeter 
    • Thermogravimetric analyzer 
    • Dynamic vapor sorption analyzer 
    • Polarized light microscope with hot stage 
    • X-ray powder diffraction 
    • Quaternary gradient HPLC systems (2 nos.) 
    • Refrigerated centrifuge 
    • Thermostated water bath with Multiposition stirrer 
    • Rotational-Vacuum-Concentrator
  • Development and in process testing of injections: 
    • Glove box, Mini 220W 
    • Lyophilizer 
    • Spray Drier 
    • High Intensity Lightmeter 
    • Turbidimeter 
    • Colorimeter 
    • Head space oxygen analyzer
  • Development for Tablet:
    • Compression Machine 
    • Rapid mixer granulator 
    • Pan coater 
    • Fluid bed processor 
    • Co Mill / multi mill 
    • Disintegration apparatus 
    • Dissolution apparatus 
    • Tap density apparatus
    • Hardness Tester
  • Analytical 
    • Subvisible Particle counter 
    • Gas chromato-graph 
    • FTIR 
    • Particle Size Anlayzer 
    • Autotitrator 
    • Cryogenic Differential scanning colorimetry 
    • HPLC with auto injectors 
    • UPLC with auto injector 
    • LC MSMS 
    • GC MSMS 
    • GC MS
  • Microbiology 
    • Autoclave
    • B.O.D. incubator
    • Bio-containment work station
    • Depyrogenating oven 
  • Stability 
    • B.O.D incubator 50°C and 60°C
    • Stability chambers 25°C/60%RH, 30°C/65%RH, 30°C/75%RH, 40°C/75%RH, 30°C/35%RH.
    • Stability walk-in chambers
    • Cold Chambers (5°C and 8°C)
    • Photostability Chamber
Mumbai Facility


Site Capabilities:

  • Injectable products - Potential to develop all types of Injectable formulations in Vials, Ampoules, LVP bags, PFS etc. 
    • Simple Injectable 
      • Aqueous based Ready to Use Injection 
      • Aqueous based Lyophilized product 
    • Complex Injectable 
      • Non-aqueous, oil based Ready to Use Injection 
      • Non-aqueous based lyophilized product 
      • Liposomal Products 
      • Micelles 
      • Nano particle Suspensions and Micro emulsions 
      • Monoclonal Antibodies 
      • Antibody Drug Conjugates 
      • Aqueous and Non aqueous suspensions 
      • Peptide and Protein
  • Lyophilized products
    • Potential to develop injection from fill volume of 1ml to 20ml and maximum 25 L is the condenser capacity.
  • Oncolytic products
    • 1300 sqft of separate processing Class 100,000 area
    • Equipped with Isolators for compounding & handling of toxic powder
      Negative pressure isolators  (-50 Pa to -150 Pa)
  • Ophthalmic products
    • Developed over 50 ophthalmic formulations
    • Expertise in developing NCE ophthalmic formulations for US & Europe.
    • Successfully developed NCE molecules for glaucoma, anti-infective and for conjuctival allergy.
  • Capability to handle all the categories of API 
    • Antibiotics (including Beta lactams) 
    • Proteins & peptides based 
    • Multivitamin & Micro nutrient 
    • High potent, Oncology API, Cyto-toxic and cyto-static 
    • Immunosuppressant 
    • Vitamins and minerals 
    • Anti-retroviral 
    • Hormones 
  • Paediatric formulation development
  • Taste Masking Technology
  • Formulation Approach by QbD principles 
  • Novel Drug Delivery Technology 

Special Features:

  • GLP Analytical Development Laboratory is registered with USFDA and have received DUNS number
  • Dedicated Project Management & Quality Assurance team
  • Dosage Forms handled in the facility include Injections, Ophthalmic, Liquid orals, Nasal drops, Ear drops, Semi-solid products.
  • Specializes in Freeze Drying Technology in the injectable and can handle highly potent product range from Hormones to Oncolytic products.
  • Expertise in Novel drug delivery systems (E.g. Liposomes, Nanoparticles, Suspensions, Micro-emulsion etc)
  • Excellent track record on pediatric formulations in India
  • Quality Management Systems are evolving to “Best in Class” level from a robust quality base facilitated by Corporate Quality Assurance

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