SREE ROTOFLEX PRIVATE LIMITED
SREE ROTOFLEX PRIVATE LIMITED is a registered company in karnataka. Its recorded business activity is manufacture of medicinal substances used in the manufacture of.
Business activity
Company profile
Manufacture Of Medicinal Substances Used In The Manufacture Of
SREE ROTOFLEX PRIVATE LIMITED is a registered company in karnataka. Its recorded business activity is manufacture of medicinal substances used in the manufacture of.
Status: Active • Registered: 2007-04-19 • NIC: 21014
A concise sample of services and capabilities associated with the recorded NIC activity.
Core execution capabilities and strengths.
Signature offerings and packaged outcomes.
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: Karnataka NCR manufacturing corridors.
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 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 that support planning, delivery, and reporting.
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
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
Design of logistics for sensitive intermediates, temperature-controlled transport plans, bonded warehousing solutions, and serialization/tracking to ensure integrity from production to customer within Karnataka NCR and outbound corridors.
Temperature-controlled; traceable
Key rows and indicator scores.
NO. 52/54, 14TH CROSS (TENT ROAD) SRIGANDHADHAKAVAL, SUNKADAKATTE, VISHWAN,EEDAM POST,BANGALORE,Bangalore,Karnataka,560091-India
NO. 52/54, 14TH CROSS (TENT ROAD) SRIGANDHADHAKAVAL, SUNKADAKATTE, VISHWAN,EEDAM POST,BANGALORE,Bangalore,Karnataka,560091-India
Contact
Talk to our team.
NO. 52/54, 14TH CROSS (TENT ROAD) SRIGANDHADHAKAVAL, SUNKADAKATTE, VISHWAN,EEDAM POST,BANGALORE,Bangalore,Karnataka,560091-India