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Omeprazole API Supplier Germany — WHO GMP Certified | Aarise Pharmaceuticals
Aarise Pharmaceuticals supplies Omeprazole (CAS 73590-58-6) to pharmaceutical manufacturers, distributors, and importers in Germany. Our WHO GMP certified facility in Haridwar, India produces Omeprazole in USP / BP / IP grade at ≥98.5% purity with full batch documentation.
Germany is Europe’s largest pharmaceutical market and a key entry point for EU-wide API distribution.
Request Omeprazole pricing for Germany — 24 hour response:
Call: +91 9899783330 | +91 9289410333
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Omeprazole — Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 73590-58-6 |
| Purity | ≥98.5% |
| Grade | USP / BP / IP |
| Category | Proton Pump Inhibitor |
| Molecular Weight | 345.42 g/mol |
| Therapeutic Use | Treatment of gerd, peptic ulcers and acid-related disorders |
| Available Forms | capsules, enteric-coated tablets |
| Storage | Store below 25°C, protect from moisture and light |
| Minimum Order | 1 kg |
| Lead Time | 7–10 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 Omeprazole from Aarise
| Factor | Aarise Advantage |
|---|---|
| Certification | WHO GMP certified facility, NABL-accredited QC lab |
| Purity | ≥98.5% — pharmacopeial specification (USP / BP / IP) |
| Documentation | Full EMA / BfArM-compliant dossier provided with every order |
| Minimum Order | From 1 kg — sample orders welcome |
| Lead Time | 7–10 days standard — expedited available |
| Pricing | Direct manufacturer pricing — no middlemen |
| Shipping | Air 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 Omeprazole 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 Omeprazole?
Minimum order is 1 kg. 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 7–10 days.
Is your Omeprazole suitable for finished dosage form manufacturing?
Yes. Our Omeprazole is USP / BP / IP grade at ≥98.5% purity — suitable for capsules, enteric-coated tablets and all standard finished dosage form manufacturing.
Request Omeprazole 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 Omeprazole Supplier | Haridwar, India | aarisepharma.com