Raw materials and
API manufacturing

Raw material procurement, manufacturing of active pharmaceutical ingredients (APIs), quality control, inventory management and supply to pharmaceutical manufacturers.

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Procurement to supply: 5 stages
Quality control: Per lot
And repeat supply: Scheduled

What goes into a medicine decides what comes out. We take an active ingredient from qualified raw materials to a released lot, and supply it to manufacturers with the records to prove it.

01 · Procurement

Raw materials from qualified sources

Every active pharmaceutical ingredient (API) starts with its raw materials. We source starting materials, reagents and intermediates from qualified suppliers, against a written specification for each one.

Each delivery is logged on receipt, sampled and checked before it can be used, so nothing enters production on the strength of a supplier label alone.

Supplier qualification and approval
A written specification for each material
Receipt, sampling and quarantine

02 · API manufacturing

Active ingredients made to a documented process

APIs are manufactured to a defined process and batch record. Each step, from synthesis and purification through to drying, is recorded against the batch, along with the raw material lots that went into it.

Scale is agreed with you: development quantities, validation batches or routine commercial supply.

Batch manufacturing records
Synthesis, purification and drying
From development to commercial scale

03 · Quality control

Tested and released lot by lot

No lot is released until it has been tested against its specification. Identity, purity and assay are confirmed by methods such as HPLC and LC-MS, alongside the further tests the specification calls for.

A Certificate of Analysis is issued for every released lot, with Safety and Technical Data Sheets where available. Retained samples are kept for each lot.

Identity, purity and assay per lot
Certificate of Analysis on release
Retained samples for each lot

04 · Inventory and supply

Stock you can plan around

Released material is held under lot-tracked inventory management, with stock levels, storage conditions and expiry or retest dates recorded for every lot.

Supply to pharmaceutical manufacturers can be scheduled against your production plan, from our UK and EU warehouses, with the lot documents travelling with each delivery.

Lot-tracked stock and retest dates
Scheduled and repeat supply
UK and EU dispatch with lot documents

Scope, equipment and accreditations for this service are to be confirmed before publication.

The process

How raw materials and API manufacturing runs

Five stages, one record: from qualified raw materials to a released lot on its way to your site.

Procurement

Raw materials are sourced from qualified suppliers, logged on receipt and checked against specification.

0Retention time25 min

Illustrative chromatogram. Separation of a sample into its components.

Scope

What the work covers

Raw material procurement
API manufacturing
Quality control and lot release
Inventory management
Supply to pharmaceutical manufacturers

Outputs

What you receive

Certificate of Analysis per lot
Batch manufacturing record summary
Safety and technical data, where available
Lot traceability record

Facilities and infrastructure

Our locations

One company, five locations across the UK, the Netherlands and India. Every service is backed by the same lot records, wherever the work happens.

About our facilities

Modern glass-fronted laboratory building exterior

United KingdomBridgendFormulation, production and manufacturingISO 7 accreditedGMP certified

Illustrative glass and white-panel laboratory exterior

United KingdomWickfordHPLC, analytical testing and freeze-dryingISO 7 accreditedGMP certified

Illustrative research building with a curved metal façade

United KingdomThetfordUK warehousing, cold-chain storage and distributionLot-tracked stockCold-chain storage

Illustrative distribution centre with loading bays and a refrigerated trailer

NetherlandsAmsterdamEU warehousing, cold-chain storage and distributionEU distributionCold-chain storage

Illustrative research building entrance with circular windows

IndiaBaddiBiologics facilityBiologics

Good to know

Before you commission this work

What to specify

The API or material, grade, specification, quantity, documents required and delivery location.

Supply planning

Expected volumes and timing let us hold stock against your schedule and confirm lead times.

Independent checks

Our analytical testing service can also check materials you already hold.

Questions

About this service

What does the service cover?

Raw material procurement, API manufacturing, quality control and lot release, inventory management and supply to pharmaceutical manufacturers. Each stage can be commissioned on its own or together.

What documents are supplied?

A Certificate of Analysis for every released lot, with Safety and Technical Data Sheets where available, and a lot traceability record linking each delivery to its batch.

Can supply be scheduled?

Yes. With expected volumes and timing, stock can be held against your production plan and dispatched on a repeat schedule.

How are availability and lead time confirmed?

Grade, specification, volumes and lead time are confirmed at quotation.

Start a project

Request a quote

Send your requirements and we will confirm the scope, documentation and lead time. It helps to include:

1The API or raw material
2Grade and specification
3Quantities and supply schedule
4Documents required