qualified manufacturers in our sourcing network.
HAYA Pharma · API imports for sterile compounding pharmacies
The portfolio belongsto your pharmacy
Not to the distributor. We bring from the source the APIs your sterile pharmacy needs, with a qualified manufacturer and documents ready for inspection.
countries we already source from.
our own office, close to the factories.
in-house cold chain for temperature-sensitive APIs.
In total, we have already brought in more than 60 APIs for sterile pharmacies.
Who decides what goes on your bench?
When the API comes from the distributor’s catalog, the distributor decides. When it comes from the source through HAYA, your pharmacy decides.
The usual model
The distributor’s catalog
- The distributor imports what sells in its own catalog.
- You buy from the stock it built, with the margin of whoever held it.
- Niche APIs are left out because they do not pay for the shelf.
- Documents arrive the way the distributor received them.
With HAYA
Your pharmacy’s portfolio
- Your demand defines what we import.
- The cost of buying straight from the manufacturer.
- Niche APIs go through the same process as high-volume ones.
- Manufacturer qualified by us at the source, and a certificate per batch.
What changes withAPIs from the source
Three things a sterile pharmacy feels on the bench and during inspections.
01
Documents that stand up to inspection
Manufacturer qualified at the source, a certificate for every batch and partner laboratories accredited by REBLAS. Traceability runs from the factory to your door.
02The API you need
Including what the distributor does not carry. You tell us the API, the dosage form and the volume; we tell you whether it can be imported, compounded, and where it comes from.
03Our own operation
An office in China, more than 80 manufacturers in 30+ countries and a 2 to 8 °C cold chain. Nobody in between.
How we bring it in
Six steps,
from source to bench
Feasibility
Before quoting, we answer three questions: can the API be imported, can it be compounded, and in which dosage form.
Manufacturer qualification
We choose and qualify the manufacturer at the source, with our team in China and a network of more than 80 manufacturers in 30+ countries.
License and approval
Import licensing and ANVISA approval handled by us, under our own AFE.
Transport and cold chain
Our own logistics. For temperature-sensitive APIs, a 2 to 8 °C cold chain from source to delivery.
Batch certificate
Every batch arrives with the manufacturer’s certificate, and quality control analysis is done with REBLAS-accredited partner laboratories.
Delivery
We deliver to your pharmacy with the batch documents.
Portfolio
APIs we havealready brought in
A sample by therapeutic family. In total, we have already brought in more than 60 APIs. The full list goes to registered pharmacies.
Family 01
Vitamins
- Vitamin B12 (methylcobalamin)01
- Vitamin C (ascorbic acid)02
- Vitamin D3 (cholecalciferol)03
+ 3 more APIs in this family, in the full list.
Family 02
Amino acids
- L-arginine01
- L-carnitine02
+ 3 more APIs in this family, in the full list.
Family 03
Minerals and trace elements
- Magnesium (dimalate)01
- Zinc (chelate)02
+ 3 more APIs in this family, in the full list.
Family 04
Antioxidants
- Alpha-lipoic acid01
- Coenzyme Q1002
+ 2 more APIs in this family, in the full list.
Compliance
Authorizedby ANVISA
We import under our own authorizations. During an inspection, that is where the trail begins.
AFE
1.32883-4
Operating Authorization to import, store, distribute, dispatch and transport.
AE
1.32878-8
Special Authorization for substances under special control, including List C5.
Quality control
REBLAS laboratories
Batch analysis is done in partnership with laboratories accredited by the Brazilian Network of Health Analytical Laboratories (REBLAS).
What comes withevery batch
- Certificate of analysis (CoA) for the batch, issued by the manufacturer
- Import documents, with ANVISA approval
- Manufacturer and source plant details
- Invoice with batch and expiry date
HAYA PharmaCore APIs
Bring us your API
Not on
the list?
That is exactly why we exist. Send us the API and get a feasibility answer.
- Send. You tell us the API (name or CAS), the dosage form and the estimated volume.
- Review. We check whether it can be imported and compounded, in which form, and where it is made with quality.
- Feasibility answer. You get the answer: whether it can be imported, the dosage form, the source and the estimated lead time.
- Proposal. Once feasibility is confirmed, you receive a proposal with manufacturer, documents and terms.
Let's talk
Your API,from the source.
Tell us what your pharmacy compounds and what is missing from the bench.
