Full-Service Contract Manufacturing
for Pharmaceutical Brands.
WHO-GMP certified. Regulatory-compliant. Flexible batch sizes from pilot to commercial scale. Five dedicated facilities delivering high-quality formulations for international brands and product owners worldwide.
End-to-End Manufacturing Services.
From initial formulation work through technology transfer, regulatory filing, and ongoing commercial supply — a single manufacturing partner for the full product lifecycle.
Formulation Development
API compatibility studies, excipient selection, prototype batch development, and accelerated stability testing to establish validated manufacturing specifications for your product.
Technology Transfer
Structured transfer from your existing manufacturer or R&D lab to our facilities — including batch record review, method bridging, equivalence confirmation, and full documentation handover.
Analytical Development
Method development and validation (HPLC, UV, dissolution, microbiological) in full compliance with ICH Q2 guidelines and the pharmacopoeial requirements of your target markets.
Regulatory Documentation
DMF preparation, CTD dossier compilation, COPP applications, WHO prequalification submissions, and registration file management for 35+ global markets.
Manufacturing
Full-scale commercial manufacturing under WHO-GMP conditions. Dedicated manufacturing slots, validated equipment, and batch traceability from raw material receipt through finished goods release.
Packaging
Primary and secondary packaging across blister, strip, bottle, ampoule, vial, and sachet configurations with full packaging validation, line clearance records, and reconciliation.
Serialization
End-to-end serialization and track-and-trace compliance for EU FMD, US DSCSA, and other regulated markets — with integration options for your existing serialization platform.
Artwork Support
Label and carton artwork design, regulatory review, approval management, and version control aligned to your target market's regulatory labelling requirements and brand standards.
Commercial Supply
Ongoing commercial supply management including rolling forecast planning, safety stock maintenance, priority batch scheduling, and on-time dispatch performance reporting.
Eight Dosage Forms. One Manufacturing Partner.
Broad formulation capabilities across solid, liquid, semi-solid, and parenteral dosage forms — manufactured under GMP conditions with full regulatory documentation.
Tablets
Immediate release, extended release, dispersible, enteric-coated, and film-coated variants under validated compression and coating conditions.
EnquireCapsules
Hard gelatin and HPMC capsules in sizes 000–5, in standard and modified-release configurations for API blends, pellets, and granules.
EnquireLiquid Orals
Syrups, suspensions, elixirs, and solutions in glass and PET packaging with full cold-chain documentation and temperature-stability data packages.
EnquireInjectables
Lyophilized and liquid injectables in ampoules, vials, and pre-filled syringes manufactured in ISO Class 5–8 clean rooms with full sterility assurance.
EnquireOintments
Medicated ointments and gels in aluminium tubes and jars, manufactured under controlled humidity and temperature with validated mixing and filling processes.
EnquireCreams
Aqueous-based pharmaceutical creams in laminate tubes — antifungal, anti-inflammatory, and dermatological formulations with validated emulsification and pH control.
EnquirePowders
Oral powder blends, granules for suspension, and bulk API handling with controlled particle size, moisture limits, and flow property testing as per specifications.
EnquireDry Syrups
Dry powder for reconstitution in HDPE bottles — suitable for paediatric and adult formulations requiring extended shelf life after manufacture and cold-chain flexibility.
EnquireThe Manufacturing Partner Brands Trust.
Seven reasons pharmaceutical companies across 35+ countries choose Laborate as their dedicated contract manufacturing partner.
WHO-GMP Certified
Facilities
Modern Manufacturing
Plants
Dedicated Key
Account Manager
Export Ready —
35+ Markets
ICH-Compliant
Quality Systems
Flexible Batch Sizes —
Pilot to Commercial
On-Time Delivery —
98.2% Dispatch Rate
From Enquiry to Commercial Supply.
A nine-stage structured manufacturing journey — transparent milestones, defined timelines, and a dedicated account manager from the first conversation to ongoing commercial supply.
Day 1
Enquiry
Submit your manufacturing enquiry — product details, target dosage form, regulatory markets, and indicative volume requirements.
Days 2–5
Feasibility
Technical review by our formulation and manufacturing teams. Facility fit assessment, equipment suitability, and regulatory alignment confirmed.
Week 2
Quotation
Detailed commercial quotation covering development costs, batch pricing, MOQ, timelines, and regulatory documentation scope.
Weeks 2–3
Agreement
Execute the manufacturing agreement, quality agreement, and confidentiality terms. IP ownership and regulatory filing rights documented.
Weeks 4–8
Technology Transfer
Structured technology transfer — batch record review, analytical method bridging, raw material qualification, and equipment validation.
Weeks 8–12
Production
Pilot batch manufacture followed by process validation batches. In-process controls, yields, and critical process parameters documented.
Weeks 12–14
QC & Release
Full finished product testing against approved specifications. Certificate of Analysis, batch summary, and release documentation issued.
Week 14+
Dispatch
Export packaging, shipping documentation, COPP certificates, and customs coordination. Cold-chain dispatch managed where applicable.
Ongoing
After Sales
Dedicated KAM support, annual product reviews, stability monitoring, regulatory change management, and post-market pharmacovigilance.
Manufacturing to the Highest Regulatory Standards.
Every batch manufactured at Laborate is backed by a comprehensive quality system aligned to international regulatory expectations — from WHO-GMP through USFDA and PIC/S.
WHO-GMP Certification
All five manufacturing facilities hold valid WHO-GMP certificates. Inspections completed on schedule — active certificates maintained for all registered export markets.
ISO 9001:2015
Quality management system certified to ISO 9001:2015, covering procurement, manufacturing, in-process testing, storage, and dispatch across all product categories.
USFDA Readiness
API manufacturing sites hold USFDA Drug Master File (DMF) registrations. Finished dosage facilities maintained to USFDA inspection standards for IND and ANDA submissions.
PIC/S Guidelines
Manufacturing practices align with PIC/S Guide to GMP, supporting market registrations across the European Union, Africa, South-East Asia, and Asia-Pacific.
Documentation Systems
Complete batch manufacturing records, validation master plans, stability protocols, deviations register, and change control managed in a validated document management system.
Regulatory Audit Support
Dedicated regulatory affairs team supports partner-initiated audits, national authority pre-approval inspections, and annual product reviews with full documentation access.
Contract Manufacturing Enquiry
Request a Manufacturing Proposal.
Share your product requirements and our technical team will review feasibility and prepare a detailed manufacturing proposal — typically within five business days.
- Feasibility assessment within 5 business days
- No-obligation commercial quotation
- Dedicated technical account manager assigned
- Full NDA / confidentiality agreement available
- Pilot batch to commercial supply — single partner
Manufacturing Enquiry
All fields marked * are required
By submitting this enquiry, you agree to our Privacy Policy. All product information shared is treated as confidential. A full NDA can be executed on request.
Speak With Our CDMO & Manufacturing Team
Prefer a conversation before submitting your enquiry? Our technical business development team is available Monday to Friday, 9am–6pm IST.