WHO GMP · USFDA · EU GMP — Sterile injectables, ophthalmics and export-grade formulation manufacturing.
Established in 1998, the Paonta Sahib Sterile & Export Plant is Laborate's flagship facility for sterile pharmaceutical manufacturing. Located in the pharmaceutical hub of Paonta Sahib, Himachal Pradesh, this plant specialises in injectables, ophthalmic solutions and export-grade formulations destined for regulated markets globally.
The facility operates under Class A/B cleanroom environments for all sterile manufacturing operations, with full environmental monitoring, validated aseptic processing lines and an on-site NABL-accredited QC laboratory. All production is executed under WHO GMP, USFDA and EU GMP frameworks simultaneously.
With 6 active manufacturing lines and a daily output capacity approaching 2 million units, Paonta Sahib supplies products to over 25 countries across Africa, Southeast Asia, Latin America and the European Union.
Line 01
Sterile Injectables (Aqueous)
600,000 ampoules / shift
Line 02
Sterile Dry Powder for Injection
250,000 vials / shift
Line 03
Eye Drops / Sterile Ophthalmic Solutions
400,000 units / shift
Line 04
Hard Capsules — Export Grade
1,800,000 capsules / shift
Line 05
Large Volume Parenterals (LVP)
120,000 bags / shift
Line 06
Unit-dose Ophthalmics / Respiratory
500,000 unit-doses / shift
Indicative daily production capacity per dosage form across all active shifts. Actual capacity subject to product-specific batch sizes and scheduling.
| Dosage Form | Daily Capacity | Unit | Shifts / Day | Notes |
|---|---|---|---|---|
| Sterile Injectables (Ampoules) | 1,200,000 | Ampoules | 2 | Class A/B aseptic processing |
| Sterile Dry Powder for Injection | 500,000 | Vials | 2 | Lyophilisation-ready line |
| Ophthalmic Eye Drops | 800,000 | Units | 2 | Multi-dose & unit-dose formats |
| Hard Gelatin Capsules | 3,600,000 | Capsules | 2 | Export-grade, EU and US market spec |
| Large Volume Parenterals (IV Bags) | 240,000 | Bags | 2 | 500ml & 1000ml formats |
All certifications held by this facility are independently audited and maintained on an ongoing basis.
Current regulatory approvals held by this facility. Certificates available on request for audit purposes.
The Paonta Sahib facility operates a fully integrated, on-site quality control laboratory that handles all testing requirements from incoming raw material inspection through in-process controls to final product release. The laboratory is NABL-accredited under ISO/IEC 17025 and operates independently from the manufacturing floor.
All analytical methods are validated to ICH Q2(R1) guidelines. Microbiological testing is performed in a dedicated, classified laboratory separate from the main QC block. Environmental monitoring of classified manufacturing areas is conducted on a continuous schedule.
The facility maintains a reference sample library for all batches manufactured, with retention periods exceeding regulatory requirements for all export markets supplied.
Chemical QC Laboratory
NABL Accredited — ISO/IEC 17025:2017 • ICH Q2(R1) validated methods
Microbiological Laboratory
ISO Class 5 Classified Suite • Environmental monitoring — sterile product lines
Stability Chamber Suite
ICH Q1A/Q1B zones — 25°C/60%RH and 40°C/75%RH • 120+ chambers
Reference Standards Library
IP/BP/USP/EP reference standards • ICH-compliant retention • Chain of custody tracking
PLT-01
Panipat, Haryana
PLT-03
Karnal, Haryana
PLT-04
Panipat, Haryana
Contact our manufacturing team to arrange a facility audit or discuss CDMO requirements.
