# APIs & intermediates

Source: https://gfclinics.pl/apis/

We supply active pharmaceutical ingredients and intermediates from Indian manufacturers that already serve the EU. Before you see a price, you see the documentation route: CEP or ASMF, inspection history, Written Confirmation.

## Built around the people who sign off a new source.

- **Procurement & sourcing**: A second source for approved molecules and shortage-prone APIs, with one EU-side partner and terms you can plan around.
- **QA & Qualified Persons**: A complete, consistent document package and a supplier you can audit, with change notifications in writing.
- **Regulatory affairs (CMC)**: A clear CEP or ASMF route for Module 3.2.S, letters of access, and the facts needed for a variation.
- **API producers & CDMOs**: Intermediates and key starting materials with documented origin, for teams reducing single-country dependence.

## What you receive before the first sample

- **CEP or ASMF (applicant’s part) with letter of access**: The documentation route is confirmed per molecule and manufacturer.
- **EU GMP certificate or inspection record**: Checked in EudraGMDP, with the inspecting authority and date.
- **Written Confirmation**: Issued by the Indian authority (CDSCO) for active substances imported into the EU (Directive 2001/83/EC, Art. 46b).
- **Specification and batch CoA**: Against the current Ph. Eur. monograph and your specification.
- **Impurity statements**: Nitrosamine risk assessment, elemental impurities (ICH Q3D), residual solvents (ICH Q3C), TSE/BSE.
- **Change control & quality agreement**: Agreed with you before commercial supply.

## From molecule list to qualified source

1. **Your list**: Molecule, grade, annual volume, current supplier and the documents you need.
2. **Route & documents**: We confirm manufacturers with a valid CEP or ASMF and send the document package for your review.
3. **Samples & audit**: Samples with batch CoA for your lab; manufacturer audit if your QA requires it.
4. **Supply**: Commercial terms agreed with us. Until our own GIF registration, active substances will be imported and delivered through a licensed Polish partner (agreement in negotiation), in original manufacturer packs.

## Clear limits protect your dossier.

- We supply active substances only to authorised manufacturers and wholesalers.
- We do not repack or relabel active substances; deliveries stay in the manufacturer’s original packaging.
- We do not supply peptide “research chemicals” or any substance for unauthorised use.
- Our own GIF registration is in preparation; until it is granted, active substances will be imported by a licensed partner named in the offer (agreement in negotiation).

## FAQ

### Do you supply APIs with a Certificate of Suitability (CEP)?

Yes, where the manufacturer holds a valid CEP issued by EDQM. Each ingredient page shows the documentation route we work with, and CEP validity can be checked in the EDQM certification database.

### Who is the manufacturer of the API?

We name the manufacturer and site in the document package we send for your review, together with its EU GMP inspection record. We do not change manufacturers without written change control.

### Can you supply small quantities for development or validation?

Often yes. Tell us the quantity and purpose; sample and validation lots depend on the manufacturer’s pack sizes.

### Which documents does an API imported from India need in the EU?

At minimum: a GMP-compliant manufacturer, a Written Confirmation from the Indian authority (or an EU-recognised equivalence), the CEP or ASMF route for your dossier, and a batch certificate of analysis. Our checklist article lists the full set.

Contact: https://gfclinics.pl/contact/