Nexcipia

BUILDING A NEXT-GEN PHARMA EXCIPIENTS PLATFORM

MCC, SSG, CCS, Crospovidone (PVPP), and Magnesium Stearate—designed to meet USP-NF/Ph. Eur./JP by grade, with IPEC-PQG GMP at go-live and a staged certification plan post-startup.

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PATENTS PIPELINE
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CORE PRODUCTS
05
GLOBAL MARKETS
IPEC-PQG GMP READY
PHARMA FOCUSED
Nexcipia Logo
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ABOUT NEXCIPIA

We are transforming the pharmaceutical excipient industry through innovative AI-powered manufacturing methods, delivering superior quality ingredients that enable smarter pharmaceutical formulations worldwide.

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PATENTS PENDING
10
PATENTS IN PREP
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MANUFACTURING PHASES
AI
MANUFACTURING

INNOVATION AT THE CORE

5 patents pending with 10 more in preparation, positioning us at the forefront of pharmaceutical excipient innovation.

AI-POWERED MANUFACTURING

Revolutionary AI methods ensure consistent quality, optimal efficiency, and reduced manufacturing costs across all product lines.

GLOBAL EXPANSION

Strategic manufacturing phases: Phase 1 in India, Phase 2 in USA, serving markets across India, USA, EU, Japan, and China.

OUR MISSION
"To revolutionize pharmaceutical manufacturing through intelligent excipients that enable safer, more effective, and accessible medications for patients worldwide."

Committed to advancing pharmaceutical science through innovation, quality, and global compliance standards.

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PRODUCT PORTFOLIO

Pharmaceutical excipients with comprehensive grade specifications designed to meet USP-NF, Ph.Eur., and JP monograph requirements.

NEXCEL™

Microcrystalline Cellulose
BINDER / DILUENTUSP-NF, Ph.Eur., JP
High-functionality microcrystalline cellulose for direct compression and wet granulation applications.

GRADE SPECIFICATIONS

GRADEPARTICLE SIZE D50MOISTURE CONTENTPH RANGEBULK DENSITYTAP DENSITYLOSS ON DRYINGPRIMARY APPLICATIONS
NEXCEL™ 10150 μm≤ 5.0%5.5 - 7.50.28 - 0.35 g/mL0.40 - 0.60 g/mL≤ 5.0%Direct compression, low-dose APIs
NEXCEL™ 10290 μm≤ 5.0%5.5 - 7.50.32 - 0.38 g/mL0.50 - 0.65 g/mL≤ 5.0%Direct compression, general purpose
NEXCEL™ 200180 μm≤ 5.0%5.5 - 7.50.31 - 0.37 g/mL0.45 - 0.60 g/mL≤ 5.0%Wet granulation, sustained release

DIRECT COMPRESSION

Recommended for 5-85% w/w loading. Optimal at 50-200 MPa compression force.

WET GRANULATION

Superior binding at 15-25% w/w. Compatible with aqueous and non-aqueous systems.

REGULATORY COMPLIANCE

Meets all three major pharmacopoeial standards. ICH Q3D compliant.

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AI-POWERED TECHNOLOGY

Revolutionizing pharmaceutical excipient manufacturing through cutting-edge artificial intelligence and machine learning technologies.

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AI-Powered Quality Control

Machine learning algorithms continuously monitor and optimize production parameters to ensure consistent product quality and reduce batch variations.

PERFORMANCE: Continuous Monitoring
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Predictive Manufacturing

Advanced AI models predict optimal processing conditions, maintenance schedules, and yield optimization for maximum efficiency.

PERFORMANCE: Predictive Analytics
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Smart Data Integration

Comprehensive data collection and analysis system integrating all manufacturing processes for intelligent decision-making.

PERFORMANCE: Real-time Analytics
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Performance Analytics

Advanced analytics platform providing insights into production efficiency, quality trends, and predictive maintenance requirements.

PERFORMANCE: 24/7 Monitoring
TECHNOLOGY CAPABILITIES
AI
QUALITY CONTROL
ML
PREDICTIVE MODELS
24/7
MONITORING SYSTEM
IoT
DATA INTEGRATION

Our patent-pending AI manufacturing system targets next-generation pharmaceutical excipient production technology.

SMART MANUFACTURING CAPABILITIES

Our AI-powered manufacturing system delivers unprecedented control and consistency across all production processes.

PROCESS OPTIMIZATION

AI continuously optimizes manufacturing parameters for maximum efficiency and quality.

REAL-TIME ADJUSTMENTS

Instant process modifications based on real-time quality monitoring and feedback.

QUALITY ASSURANCE

Automated quality control systems ensure consistent product specifications.

PRECISION CONTROL

Precise control of particle size, moisture content, and critical parameters.

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MANUFACTURING

Strategic global manufacturing approach with ultra-modern, AI-enhanced facilities delivering world-class pharmaceutical excipients.

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PHASE 1 - INDIA FACILITY

Planned state-of-the-art manufacturing facility in India utilizing advanced AI-powered production systems. Designed for high-volume production with uncompromised quality standards.

50,000
SQ FT PLANNED
GMP
COMPLIANCE
SCALABLE
OPERATIONS
AI
POWERED
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PHASE 2 - USA EXPANSION

Planned expansion to the United States market with a dedicated manufacturing facility to serve North American pharmaceutical companies with reduced lead times.

STATUS: PLANNING PHASE
MANUFACTURING CAPABILITIES
PRODUCT LINES
Microcrystalline Cellulose, Sodium Starch Glycolate, Croscarmellose Sodium, Crospovidone, Magnesium Stearate
TARGET STANDARDS
• IPEC-PQG GMP Guide (V5, 2022)
• NSF/IPEC/ANSI 363
• USP-NF / Ph.Eur. / JP Monographs
• USP <467> Residual Solvents
• ICH Q3D Elemental Impurities
PLANNED CERTIFICATIONS
• ISO 9001:2015 (Quality Management)
• ISO 14001:2015 (Environmental)
• ISO 45001:2018 (Occupational Health)
• EXCiPACT Certification

TARGET MARKETS

Strategic positioning to serve key pharmaceutical markets worldwide with localized manufacturing and distribution.

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INDIA
PLANNING
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USA
PLANNING
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EUROPE
PLANNING
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JAPAN
PLANNING
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CHINA
PLANNING
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REGULATORY & QUALITY

Comprehensive quality management and regulatory compliance framework supporting global pharmaceutical excipient requirements through rigorous standards and documentation.

Standards & Compliance Framework

EXCIPIENT GMP STANDARDS

IPEC FEDERATION
PLANNED
Excipient-specific Good Manufacturing Practice guidelines from IPEC Federation
U.S. excipient GMP standard - American National Standard for pharmaceutical excipient quality assurance
Independent excipient GMP certification scheme - Global certification programme for third-party GMP verification

ISO MANAGEMENT SYSTEMS

TARGETS
PLANNED
ISO 9001:2015 Quality Management
Quality management systems - Requirements for consistent product quality
ISO 14001:2015 Environmental
Environmental management systems - Sustainable operations framework
ISO 45001:2018 Occupational Safety
Occupational health and safety management (replacing OHSAS 18001)

Compendial Compliance & Safety

PHARMACOPOEIAL COMPLIANCE

USP-NF
United States Pharmacopoeia
Ph.Eur.
European Pharmacopoeia
JP
Japanese Pharmacopoeia
Class 1, 2, and 3 solvent controls per USP general chapter requirements
Elemental impurity risk assessment and control strategy implementation

SAFETY DECLARATIONS

Allergen Status
Product-specific allergen declarations per FDA and EU requirements
BSE/TSE Free
Bovine and Transmissible Spongiform Encephalopathy certificates where applicable
Non-GMO
Genetically Modified Organism status declarations
Vegan Suitable
Animal-derived ingredient declarations
Kosher/Halal
Religious dietary compliance certificates available upon request

Regulatory Documentation Pathways

US REGULATORY PATHWAY

FDA
PREP
Type IV DMF is the correct DMF type for excipients - comprehensive technical documentation for FDA submission
cGMP Compliance Documentation
21 CFR Part 210/211 compliance framework and documentation

EU REGULATORY PATHWAY

EDQM
PLAN
Certificates of Suitability (CEPs)
European Directorate for Quality of Medicines CEP applications
GMP Compliance (EudraLex Volume 4)
EU Good Manufacturing Practice guidelines compliance
REGULATORY NOTE
The FDA does not approve or certify manufacturing facilities for excipients. We maintain cGMP alignment and provide comprehensive support for customer qualification audits and regulatory inspections.
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CONTACT

Get in touch with our technical team for product inquiries, custom specifications, or partnership opportunities.

CONTACT INFORMATION
PHONE
+1 (214) 214-4988
RESPONSE TIME
Within 24 hours
TECHNICAL SUPPORT
Our technical team is available to discuss product specifications, regulatory requirements, and custom formulation needs.
OFFICE LOCATIONS
INDIA (PHASE 1)
Manufacturing & Operations
USA (PHASE 2)
Planned Expansion