Drug Product

Empowering Innovation with
State-of-the-Art Infrastructure

CRAMSN Research Park offers cutting-edge infrastructure and comprehensive capabilities to meet client needs from discovery through commercialization.

1

State-of-the-art
R&D Centers

18

API Manufacturing
Units

7

Fully-Integrated
FDF Facilities

1

Fully-Integrated FDF Facility
in New New Jersey, USA.

Through in-depth analyses and expert insights, CRAMSYNTH Pulse highlights groundbreaking advancements and practical applications within the field, reflecting our commitment to excellence and innovation in scientific research and development.

End-to-End Solutions

CRAMSN Research Park offers comprehensive one-stop-shop CRO, CDMO, and CMO services with scalable infrastructure supporting everything from grams to tonnes production.

Research & Development

40 advanced chemistry labs with specialized capabilities for diverse pharmaceutical development needs.

  • Route scouting and feasibility studies
  • QbD-based optimization
  • Process development and scale-up
  • Technology transfer support

Manufacturing
Excellence

cGMP-compliant manufacturing facilities with continuous process- ing capabilities.

  • Clinical trial manufacturing
  • Commercial scale production
  • Regulatory-compliant operations
  • Flexible campaign-based production

Analytical
Services

45,000 sq ft dedicated analytical facility with comprehensive testing capabilities.

  • Method development and validation
  • Genotoxic impurity assessments
  • Nitrosamine impurity testing
  • Stability studies and analysis
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Specialized Laboratories

Our R&D center hosts dedicated labs tailored for diverse specialties, including:

  • High-potency active pharmaceutical ingredients (HPAPIs)
  • Prostaglandins, labeled compounds, and iron complexes
  • Flow chemistry, peptides, oligonucleotides
  • Particle size engineering
Specialized Laboratories

Advanced Synthetic Capabilities

Specialized engineering labs focusing on process safety studies and process intensification to enhance operational efficiency.

40

Synthetic Labs

~350

Fume Hoods

Advanced Synthetic Capabilities
Scale-Up Facilities

10 L - 100 L

Reactor capacities under CGMP standards

PHASE I, II & III

CLINICAL TRIALS

Clean room facilities ensuring stringent compliance with clinical development needs.

Scale-Up Facilities

CRAMSN’s manufacturing infrastructure is built to support production at every scale, from grams to tons, while upholding the highest standards of quality and compliance. Our advanced drug substance and drug product facilities are equipped to fulfill a diverse range of client requirements.

Drug Substance Manufacturing

Our API manufacturing capabilities include a robust setup for producing a diverse array of drug substance

Manufacturing
Scale

17

Manufacturing Facilities

2,400 +

Reactors

10,000 KL

Combined Reaction Volume

Cryogenic Reactor

12 KL

Operating Range: -90°C to 140°C Specialized for temperature-sen-sitive reactions

2 HPAPI Facilities

< 0.1 Mg/M3

Ultra-low exposure containment OEB 5 compliance capability

Hydrogenation Facility

6 KL

Pressure Range: 5 - 10Kg/cm2 Specialized hydrogenation capabilities

Spray Dryer

10 KG/BATCH

Liquid formulation capabilities for pediatric and specialized dosing

Particle Size Reduction

< 10 MICRON

GMCA & Non-GMCA facility in class 100,000 area Precision particle engineering

Reactor Range

20 L - 20 KL

Capacities for tailored production scalability.


Drug Product Manufacturing

CRAMSN’s extensive FDF manufacturing capabilities allow for high-volume production across a wide variety of drug forms.

FDF Production Capacities

Tablets

~12 Bn

High-speed tablet manufacturing with advanced compression technology

Capsules

~100 Mn

Hard and soft gelatin capsule
manufacturing

Sachets

~100 Mn

Flexible sachet packaging for powder and granule formulations

Oral Suspensions

~7Mn

Liquid formulation capabilities for pediatric and specialized dosing

Parenterals (Lyo & Liquids)

~ 40 Mn

Lyophilized & liquid injectable
formulations

Granules

~100 Tons

Large-scale capsule production for
bulk requirements

Compliance & Quality Standards

Meeting the highest international regulatory standards for pharmaceutical manufacturing and development.

US FDA
Edom
Who Geneva
Health Canada
PMDA
MHRA UK

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