Statutory record
Licences, consents, and what is still a roadmap.
Corporate statements on this site follow verified regulatory facts. Certifications that are still in qualification are described as future work, not as current approvals.
WHO-GMP is scheduled, not claimed.
The facility is engineered along cGMP and WHO-GMP layout principles and holds an active manufacturing licence. Formal WHO-GMP compliance is a roadmap item, with audit staging planned for 2027. It is not a current certification.
Current licences and consents
| Licence | Reference | Authority | Status |
|---|---|---|---|
Commercial Manufacturing Licence Manufacture of semi-finished pharmaceutical pellet dosage forms for formulation use. Primary commercial manufacturing authority for pellet formulations. | TG/MDL/2026-146406Issued 06/03/2026Validity 05/03/2031 | Drugs Control Administration, Government of Telangana | Active |
Consent for Operation (CFO) Environmental compliance for pharmaceutical pellet manufacturing, air emissions, and effluent management. Environmental consent for operational capacity in IDA Gandhi Nagar, Kukatpally. | 1816-RR-II/TGPCB/ZOH/TG-IPASS/CFO/2025-1125Issued 19/09/2025Validity Active under TG-iPASS | Telangana State Pollution Control Board (TGPCB) | Active |
Import Export Code (IEC) Authority for cross-border export of pharmaceutical pellets and starter cores. Provides foundational export entitlement for global customer engagements. | Active IEC Registration | Directorate General of Foreign Trade (DGFT), Ministry of Commerce & Industry | Active |
Factory Operational Licence Industrial safety, structural integrity, and workforce welfare compliance. Mandatory operational factory clearance. | Department of Factories Registration | Department of Factories, Government of Telangana | Active |
Central Food Safety Licence Manufacturing and supply of neutral sugar spheres (starter cores) and nutritional mineral blends. Covers neutral sucrose/starch cores and nutritional pellet formulations. | FSSAI Central Registration | Food Safety and Standards Authority of India (FSSAI) | Active |
Open Part DMF portfolio
Open Part Drug Master File dossiers are in preparation for the molecules below. “In preparation” is not the same as a filed or accepted DMF.
| Formulation | Potency | Release | Documentation in scope |
|---|---|---|---|
| Omeprazole Enteric Coated Pellets | 7.5% w/w | Enteric Coated (EC) | Open Part DMF in Preparation Process validation summary, specification, stability data, analytical test procedures. |
| Itraconazole Immediate Release Pellets | 22.5% w/w | Immediate Release (IR) | Open Part DMF in Preparation Active solid dispersion characterization, in-vitro dissolution profile, batch analysis data. |
| Pantoprazole Sodium Enteric Coated Pellets | 15.0% w/w | Enteric Coated (EC) | Open Part DMF in Preparation Acid resistance validation, impurity profiling, packaging qualification. |
| Domperidone Sustained Release Pellets | 30.0% w/w | Sustained Release (SR) | Open Part DMF in Preparation Controlled diffusion profiling across GI pH range, accelerated stability data. |
| Rabeprazole Sodium Enteric Coated Pellets | 8.5% w/w / 7.5% w/w | Enteric Coated (EC) | Open Part DMF in Preparation Stabilized sub-coat verification, gastro-resistance dissolution data, CoA. |
Four governance pillars
01
Schedule M / cGMP Adherence
Engineering systems, epoxy cleanroom corridors with coving, air handling zoning, and strict Standard Operating Procedures (SOPs) aligned with revised Schedule M requirements.
02
Data Integrity & Traceability
Comprehensive Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) capturing every process parameter, temperature gradient, and QC analytical release check.
03
Validated Purified Water System
Continuous recirculating loop validated across all three qualification phases (Phase I, Phase II, Phase III) with fail-safe automatic dump valves and point-of-use UV sanitation.
04
Roadmap Toward WHO-GMP (2027)
Facility upgrades, documentation formalization, and pre-audit readiness activities currently scheduled for formal WHO-GMP compliance for targeted export dossiers.
Regulatory dossiers and sample certificates of analysis.
Regulatory Affairs can discuss technical data packages, audit scheduling and DMF access letters.