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Prednisolone API Supplier USA — WHO GMP Certified | Aarise Pharmaceuticals
Aarise Pharmaceuticals supplies Prednisolone (CAS 50-24-8) to pharmaceutical manufacturers, distributors, and importers in USA. Our WHO GMP certified facility in Haridwar, India produces Prednisolone in USP / BP / IP grade at ≥99.0% purity with full batch documentation.
The USA is the world’s largest pharmaceutical market. Generic API demand exceeds $50B annually.
Request Prednisolone pricing for USA — 24 hour response:
Call: +91 9899783330 | +91 9289410333
Send Inquiry →
Prednisolone — Technical Specifications
| Parameter | Specification |
|---|---|
| CAS Number | 50-24-8 |
| Purity | ≥99.0% |
| Grade | USP / BP / IP |
| Category | Corticosteroid |
| Molecular Weight | 360.44 g/mol |
| Therapeutic Use | Anti-inflammatory, immunosuppressant, allergy and asthma treatment |
| Available Forms | tablets, oral solution, eye drops |
| Storage | Store at 15–25°C, protect from light |
| Minimum Order | 500 g |
| Lead Time | 5–7 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 Prednisolone from Aarise
| Factor | Aarise Advantage |
|---|---|
| Certification | WHO GMP certified facility, NABL-accredited QC lab |
| Purity | ≥99.0% — pharmacopeial specification (USP / BP / IP) |
| Documentation | Full FDA-compliant dossier provided with every order |
| Minimum Order | From 500 g — sample orders welcome |
| Lead Time | 5–7 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 Prednisolone 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 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 USA 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 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 Prednisolone Supplier | Haridwar, India | aarisepharma.com