Manufacturing
Pharmaceutical contract manufacturing in Uzbekistan: how it works
Contract manufacturing in Uzbekistan has moved out of the niche. A growing domestic market, preferences for locally made products in public tenders and mandatory GMP from 2027 have turned a local site into a practical market-entry tool. Here is how cooperation is structured and what is required from the customer.
Three main models
| Model | Essence | Best suited for |
|---|---|---|
| Contract manufacturing (CMO) | Production to the customer's documentation under the customer's brand | Companies with a complete dossier and brand |
| Licensed production | Manufacturing a partner's product under transferred technology, usually with local registration | Foreign manufacturers localising a portfolio |
| Private label | Production under the customer's brand based on the site's own development | Distributors and pharmacy chains building an own brand |
What the customer provides
- Complete technological documentation: composition, raw material and finished product specifications, control methods.
- Analytical methods with validation details and, where required, reference standards.
- Stability data, or agreement to run stability studies at the site.
- Packaging requirements and artwork reflecting local labelling rules.
- Regulatory status: registration in the country of origin, quality certificates.
What the site provides
- Production areas of the required cleanliness class and qualified equipment.
- A quality system and GMP documentation: SOPs, validation protocols, personnel training.
- Incoming raw material control and finished product quality control.
- Compliant storage conditions and dispatch.
- Support for local registration regarding the manufacturing part of the dossier.
Available dosage forms and capacity
The site profile defines which products can be manufactured at all. Laxisam Pharmaceuticals capabilities:
| Dosage form | Capacity | Formats |
|---|---|---|
| Ampoules | up to 24,000 per hour; 14.2 million per year in single-shift mode | 2 ml, 5 ml, 10 ml |
| Tablets | tablet press 80,000 per hour | — |
| Capsules | capsule filling machine 50,000 per hour | — |
| Blister packaging | 14.8 million packs per year | — |
A four-storey building of 6,750 m² is under construction for suppositories, syrups and ointments, which will extend the range of available forms.
How the process usually runs
- Feasibility assessment: review of the form, composition and equipment requirements.
- Non-disclosure agreement and exchange of technical documentation.
- Commercial terms and contract, including a Quality Agreement.
- Technology transfer: process adaptation and trial runs at the site.
- Validation batches confirming reproducible quality.
- Regulatory actions — registration or variation.
- Routine commercial production and ongoing quality control.
Why Uzbekistan
- A growing domestic market and access to CIS markets.
- Preferences for local production in government procurement.
- Mandatory GMP from 1 January 2027 — sites holding a valid certificate become a limited resource.
- Lower production and logistics costs compared with importing finished products.
Frequently asked questions
- How does contract manufacturing differ from licensed production?
- In contract manufacturing the site produces to the customer's documentation under the customer's brand. Licensed production involves transferring the partner's technology and usually a local registration. The key difference is who holds the marketing authorisation.
- Which dosage forms are available?
- Ampoules (2, 5 and 10 ml), tablets and capsules, plus blister packaging. A building for suppositories, syrups and ointments is under construction.
- What is the production capacity?
- Up to 24,000 ampoules per hour (14.2 million per year in single-shift mode), a tablet press at 80,000 tablets per hour, capsule filling at 50,000 per hour and 14.8 million blister packs per year.
- Does the site hold a GMP certificate?
- Yes — national GMP certificate No. GMP-08:2024 issued in April 2024, and manufacturing licence No. 15998.
- What is needed to start?
- Technological documentation, analytical methods, stability data, packaging requirements and the regulatory status of the product.