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Prednisolone API Supplier Germany — WHO GMP Certified | Aarise Pharmaceuticals

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Aarise Pharmaceuticals supplies Prednisolone (CAS 50-24-8) to pharmaceutical manufacturers, distributors, and importers in Germany. Our WHO GMP certified facility in Haridwar, India produces Prednisolone in USP / BP / IP grade at ≥99.0% purity with full batch documentation.

Germany is Europe’s largest pharmaceutical market and a key entry point for EU-wide API distribution.

Request Prednisolone pricing for Germany — 24 hour response:
Call: +91 9899783330 | +91 9289410333
Send Inquiry →


Prednisolone — Technical Specifications

ParameterSpecification
CAS Number50-24-8
Purity≥99.0%
GradeUSP / BP / IP
CategoryCorticosteroid
Molecular Weight360.44 g/mol
Therapeutic UseAnti-inflammatory, immunosuppressant, allergy and asthma treatment
Available Formstablets, oral solution, eye drops
StorageStore at 15–25°C, protect from light
Minimum Order500 g
Lead Time5–7 days

Regulatory Documentation for Germany (EMA / BfArM)

EU API imports require compliance with EU GMP Directive 2001/83/EC. Aarise provides EU-CTD format dossiers and EDQM CEP support.

Aarise provides the following documentation for Germany importers:

  • Batch-specific Certificate of Analysis (COA) — HPLC purity confirmed, NABL-accredited lab
  • MSDS / SDS in GHS format
  • WHO GMP Certificate (facility)
  • Certificate of Pharmaceutical Product (COPP)
  • Drug Master File (DMF) support — EMA / BfArM format
  • Impurity profile and residual solvents data
  • Stability data and shelf-life documentation
  • Certificate of Origin

Regulatory authority: European Medicines Agency (EMA) and Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Documentation provided: EU GMP-equivalent COA, EDQM CEP support where applicable, EMA-format MSDS, DMF (EU-CTD format)


Why Germany Buyers Source Prednisolone from Aarise

FactorAarise Advantage
CertificationWHO GMP certified facility, NABL-accredited QC lab
Purity≥99.0% — pharmacopeial specification (USP / BP / IP)
DocumentationFull EMA / BfArM-compliant dossier provided with every order
Minimum OrderFrom 500 g — sample orders welcome
Lead Time5–7 days standard — expedited available
PricingDirect manufacturer pricing — no middlemen
ShippingAir and sea freight to Germany — full export documentation

Frequently Asked Questions

Can I get a COA and MSDS before placing a bulk order?
Yes. Aarise provides batch-specific COA and MSDS before any order commitment. Sample quantity available from 50–100g.

Do you provide EMA / BfArM-compliant documentation?
Yes. All Prednisolone orders for Germany include EMA / BfArM-format COA, WHO GMP certificate, COPP, and MSDS. DMF support available on request.

What is the minimum order quantity for Prednisolone?
Minimum order is 500 g. Sample orders from 50–100g for qualification purposes. Contact us for bulk pricing above 10 kg.

How long does delivery to Germany take?
Air freight: 3–5 business days from dispatch. Sea freight: 18–25 days. Standard lead time from order to dispatch is 5–7 days.

Is your Prednisolone suitable for finished dosage form manufacturing?
Yes. Our Prednisolone is USP / BP / IP grade at ≥99.0% purity — suitable for tablets, oral solution, eye drops and all standard finished dosage form manufacturing.


Request Prednisolone Quote for Germany

Specify: quantity required, grade (USP / BP / IP), target delivery timeline, and any EMA / BfArM-specific documentation requirements.

Call: +91 9899783330 | +91 9289410333
Send Inquiry Form →
Aarise Pharmaceuticals | WHO GMP Certified Prednisolone Supplier | Haridwar, India | aarisepharma.com