Compliance & Quality
We maintain the highest standards of compliance, quality, and regulatory adherence in all our operations.
Traceability & Lot Tracking
Complete product traceability throughout the supply chain
Serialization
All products are serialized with unique identifiers (GTIN, Serial Number, Lot, Expiry) enabling complete traceability from manufacturer to end customer.
Transaction History
Comprehensive transaction history maintained for all products, ensuring full traceability and compliance with DSCSA requirements.
Lot Tracking
Advanced lot tracking system enables rapid identification and isolation of products in case of recalls or quality issues.
Cold-Chain Integrity
Temperature-controlled storage and transport
Temperature Monitoring
Continuous temperature monitoring during storage and transport using calibrated data loggers and real-time alerts for temperature excursions.
Validated Equipment
All cold storage facilities and transport vehicles are validated and maintained according to GDP guidelines, ensuring product integrity.
Documentation
Complete temperature records maintained for all cold-chain shipments, available for audit and regulatory review.
Licensing & Audits
Regulatory compliance and quality certifications
Wholesale Drug License
Valid wholesale drug license issued by state regulatory authorities, ensuring compliance with all distribution requirements.
Good Distribution Practices
Full adherence to Good Distribution Practices (GDP) guidelines, ensuring product quality and integrity throughout the distribution process.
Regular Audits
Regular internal and external audits conducted to ensure continuous compliance with all regulatory requirements and quality standards.
Recalls & Notices
Current and recent product recalls and safety notices
Paracetamol 500mg Tablets
Lot: LOT-2023-ABC-123
Reason: Labeling error - incorrect expiry date
1/15/2024
REC-2024-001
Amoxicillin 250mg Capsules
Lot: LOT-2023-XYZ-456
Reason: Potential packaging defect
2/3/2024
REC-2024-002
Ibuprofen 400mg Tablets
Lot: LOT-2024-DEF-789
Reason: Temperature excursion during transport
2/20/2024
REC-2024-003
Important Notice
This website and its content are provided for informational purposes only. The information contained herein is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.
Product information, including but not limited to indications, dosages, and contraindications, should be verified with the manufacturer's prescribing information. Niti Pharma does not provide medical advice or recommendations regarding the use of any pharmaceutical products.