Business activity

Company profile

Company overview

Manufacture Of Medicinal Substances Used In The Manufacture Of

DATATRACK TECHNOLOGIES PRIVATE LIMITED is a registered company in kerala. Its recorded business activity is manufacture of medicinal substances used in the manufacture of.

Status: Active • Registered: 2014-03-18 • NIC: 21000

A concise sample of services and capabilities associated with the recorded NIC activity.

Manufacture Of Medicinal Substances Used In The Manufacture Of overview

Integrated pharma manufacturing in Kerala NCR focused on production of medicinal substances for active pharmaceutical ingredients, compliant with Section C manufacturing standards and NIC code 21001.

End-to-end GMP-aligned facilities including formulation support, stability testing, and QA/QC laboratories tailored for medicinal chemical and botanical intermediates.

Tech-enabled operations with traceability, cold-chain logistics, and supply chain integration across manufacturing corridors to support regulatory filings and scale-to-market timelines.

Capabilities

Core execution capabilities and strengths.

Formulation of medicinal substances and intermediates under Class 2100 practices, with batch documentation suitable for regulatory dossiers.

Analytical development and quality control: method validation, stability studies, impurity profiling, and certificate of analysis generation in accredited labs.

Manufacturing scale-up and contract manufacturing: pilot batches through commercial scale with controlled environment suites, cleanroom management, and serialized product tracking.

Integrated logistics and distribution across Kerala NCR corridors with temperature-controlled transport, bonded warehousing, and vendor qualification workflows.

Manufacture Of Medicinal Substances Used In The Manufacture Of offerings

Signature offerings and packaged outcomes.

Active Pharmaceutical Ingredient (API) Contract Manufacturing

End-to-end contract manufacturing of active pharmaceutical ingredients aligned with NIC code 21001. Services include process development, scale-up, GMP-compliant production, and transfer to sterile fill-finish partners. Facilities and workflows are optimized for medicinal substances used in pharmaceutical manufacture, with quality systems meeting Indian regulatory requirements and international customer specifications.

Capacity: batch and continuous processing; compliance: GMP; location: Kerala NCR manufacturing corridors.

Process Development & Analytical Services

Technical development for novel and generic medicinal substances: route scouting, impurity profiling, analytical method development and validation, stability studies, and technology transfer documentation. Analytical laboratories provide HPLC, LC-MS, and associated method validation for regulatory filings and commercial release.

Equipment: HPLC/LC-MS; deliverables: validated methods and stability reports; timeframe: 8–20 weeks.

Regulatory Support & Quality Assurance

Regulatory strategy and dossier preparation for domestic and export markets, including master files, GMP certification support, and batch release oversight. Quality assurance services span supplier qualification, risk-based change control, and CAPA implementation to ensure product traceability and compliance.

Services: DMF/ASMF support, GMP audits, QA oversight; outcome: regulatory-ready documentation.

Services and capabilities

Services that support planning, delivery, and reporting.

Process Development & Scale-Up

Technical development from lab scale to pilot and commercial batches, including reaction optimization, impurity profiling, solvent recovery strategies, and tech transfer documentation for manufacture of medicinal substances.

Scalable process kits; risk mitigation

Quality Management & Regulatory Affairs

Establishment and maintenance of QMS, batch record templates, change control, CAPA systems, and preparation of regulatory submissions aligned to Indian and international expectations for NIC 21001 activities.

Regulatory dossiers; GMP-ready QMS

Logistics & Cold-Chain Planning

Design of logistics for sensitive intermediates, temperature-controlled transport plans, bonded warehousing solutions, and serialization/tracking to ensure integrity from production to customer within Kerala NCR and outbound corridors.

Temperature-controlled; traceable

Company registration details

Key rows and indicator scores.

Company metrics

  • Authorized capital: ₹ 10.0 L
  • Paid-up capital: ₹ 10.0 L
  • Metric: Value

Operational details

  • CIN: U21000KL2014PTC036457
  • Company status: Active
  • Registration date: 2014-03-18
  • Company class: Private
  • Company category: Company limited by shares
  • Company sub-category: Non-government company
  • Listing status: Unlisted
  • Registrar of Companies: ROC Ernakulam
  • Registered state: kerala
  • NIC code: 21000
  • Recorded business activity: Manufacture Of Medicinal Substances Used In The Manufacture Of

Location map

13/923G, GROUND FLOOR, OPP:KARUMAKKAD JUMA MASJID THOPPIL-MODEL ENGINEERING COLLEGE ROAD,,THRIKKAKARA,Ernakulam,Kerala,682021-India

13/923G, GROUND FLOOR, OPP:KARUMAKKAD JUMA MASJID THOPPIL-MODEL ENGINEERING COLLEGE ROAD,,THRIKKAKARA,Ernakulam,Kerala,682021-India

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