Contract Manufacturing (CDMO)

End-to-end pharmaceutical CDMO services. From formulation development to commercial supply. WHO-GMP and EU-GMP certified facilities.

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Services

What We Offer

Formulation Development

From API to finished dosage form. IR, SR, MR, EC tablets. Capsules, liquids, injectables, ointments. Taste-masking and stability optimization.

Analytical & Stability

Method development, validation, forced degradation. ICH stability studies. Certificate of Analysis for every batch.

Regulatory Support

CTD/eCTD dossier preparation. CDSCO, ANDA (US), EU, WHO PQ, Africa zone filings. DMF and ASMF support.

Scale-Up & Validation

Lab → pilot → commercial scale-up. Process validation (3 consecutive batches). Equipment qualification (IQ/OQ/PQ).

Commercial Manufacturing

Dedicated and shared manufacturing lines. Batch sizes from 50,000 to 5 million units. Flexible MOQs for market entry.

Packaging & Labelling

Blister, strip, bottle, sachet, vial, ampoule packaging. Customer-specific labelling. Serialization for regulated markets.

How It Works

Engagement Process

1

Inquiry & Feasibility

Share your requirements. We assess feasibility, timeline, and provide a commercial proposal within 7 working days.

2

Development Agreement

NDA and development agreement signed. Project plan with milestones, timelines, and deliverables.

3

Formulation & Analytical

R&D develops the formulation. Analytical methods developed and validated. Prototype samples for your review.

4

Stability & BE

ICH stability studies initiated. Bioequivalence study coordination if required. Regulatory dossier preparation.

5

Scale-Up & Validation

Pilot batches → exhibit batches → process validation. All documentation per GMP requirements.

6

Commercial Supply

Ongoing commercial manufacturing with agreed quality standards, lead times, and pricing. Annual product quality reviews.

Capabilities

Dosage Forms We Manufacture

Tablets (plain, film-coated, sugar-coated)
Capsules (hard gelatin, HPMC)
Sustained/Modified Release
Enteric-Coated
Oral Liquids (syrups, suspensions, solutions)
Dry Syrups
Ointments, Creams, Gels
Small Volume Parenterals (ampoules, vials)
Large Volume Parenterals (IV fluids)
Dry Powder Injectables
Softgel Capsules
Sachets & Powders

Ready to Partner?

Share your requirements and we'll respond with a feasibility assessment and commercial proposal within 7 working days.

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