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Omeprazole API Supplier USA — WHO GMP Certified | Aarise Pharmaceuticals
Aarise Pharmaceuticals supplies Omeprazole (CAS 73590-58-6) to pharmaceutical manufacturers, distributors, and importers in USA. Our WHO GMP certified facility in Haridwar, India produces Omeprazole in USP / BP / IP grade at ≥98.5% purity with full batch documentation.
The USA is the world’s largest pharmaceutical market. Generic API demand exceeds $50B annually.
Request Omeprazole pricing for USA — 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 USA (FDA)
US API imports require FDA registration and cGMP compliance. Aarise provides DMF support for ANDA and NDA submissions.
Aarise provides the following documentation for USA 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 — FDA format
- Impurity profile and residual solvents data
- Stability data and shelf-life documentation
- Certificate of Origin
Regulatory authority: U.S. Food and Drug Administration (FDA)
Documentation provided: cGMP-format COA, DMF (Drug Master File) support, FDA-format stability data, MSDS in GHS format
Why USA 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 FDA-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 USA — 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 FDA-compliant documentation?
Yes. All Omeprazole orders for USA include FDA-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 USA 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 USA
Specify: quantity required, grade (USP / BP / IP), target delivery timeline, and any FDA-specific documentation requirements.
Call: +91 9899783330 | +91 9289410333
Send Inquiry Form →
Aarise Pharmaceuticals | WHO GMP Certified Omeprazole Supplier | Haridwar, India | aarisepharma.com