Prednisolone API Manufacturer & Exporter in Mumbai, India

Prednisolone API Manufacturer and Exporter in Mumbai, India | Aarise Pharmaceuticals

Aarise Pharmaceuticals is a WHO GMP certified Prednisolone API manufacturer and exporter based in India, supplying formulation companies and distributors in Mumbai and internationally. Our Prednisolone API meets USP and BP pharmacopoeial standards at 99%+ HPLC purity, and is backed by complete batch documentation including Certificate of Analysis, MSDS, Certificate of Origin, and regulatory support for export markets. As one of India’s established Prednisolone API suppliers, we serve Mumbai buyers with fast dispatch, competitive pricing, and dedicated export team support.

About Prednisolone API

Prednisolone is a synthetic corticosteroid and one of the most widely used anti-inflammatory and immunosuppressive agents in pharmaceutical formulations. As the active form of prednisone in the body, Prednisolone is used in oral tablets, syrups, eye drops, injectables, and topical preparations across therapeutic areas including rheumatology, respiratory medicine, dermatology, gastroenterology, and ophthalmology.

Chemically, Prednisolone is 11β,17,21-trihydroxypregna-1,4-diene-3,20-dione with CAS Number 50-24-8 and molecular formula C₂₁H₂₈O₅ (MW: 360.44). It is a white to almost white crystalline powder, practically insoluble in water but soluble in methanol and ethanol. The API is stable under standard pharmaceutical manufacturing conditions when stored properly (below 25°C, away from light and moisture).

Key therapeutic applications of Prednisolone API:

• Rheumatoid arthritis and autoimmune disorders (oral tablets)
• Asthma and COPD management (oral tablets, injectables)
• Inflammatory bowel disease (oral tablets, enemas)
• Dermatological conditions — eczema, psoriasis (topical formulations)
• Ophthalmic conditions — uveitis, conjunctivitis (eye drops — Prednisolone Acetate)
• Organ transplant rejection prevention (high-dose oral formulations)
• Nephrotic syndrome (paediatric and adult oral formulations)
• Allergic reactions and anaphylaxis management

Prednisolone API Specifications

Our Prednisolone API is manufactured and tested to USP and BP pharmacopoeial specifications. Key quality parameters:

• Description: White to off-white crystalline powder
• CAS Number: 50-24-8
• Molecular Formula: C₂₁H₂₈O₅
• Molecular Weight: 360.44 g/mol
• Grade: USP / BP / EP
• Purity (HPLC): 99.0%+ (NLT 97.0% per USP specification)
• Melting Point: 225–228°C
• Specific Rotation: +97° to +103° (in dioxan)
• Water Content (Karl Fischer): NMT 1.0%
• Residual Solvents: Meets ICH Q3C Class 2/3 limits
• Microbial Limits: Meets USP/BP pharmacopoeial limits
• Related Substances: Individual: NMT 0.5%; Total: NMT 1.0%
• Shelf Life: 36 months from date of manufacture
• Storage: Store below 25°C, in a dry place, protected from light

Available Prednisolone Forms and Derivatives

In addition to Prednisolone base API, we supply the following Prednisolone derivatives used in specialised formulations:

• Prednisolone Acetate API (CAS: 52-21-1) — BP/USP grade, 99%+ purity. Used in ophthalmic suspensions, topical creams, and injectables
• Prednisolone Sodium Phosphate API (CAS: 125-02-0) — USP grade, 98%+ purity. Water-soluble form used in IV injectables, oral solutions, and eye drops
• Prednisolone Hemisuccinate API — BP grade, 98%+ purity. Soluble ester form used in parenteral formulations
• Methylprednisolone API (CAS: 83-43-2) — USP grade, 99%+ purity. Related corticosteroid for injectable and oral anti-inflammatory formulations

Manufacturing and Quality Assurance

Aarise Pharmaceuticals manufactures Prednisolone API at our WHO GMP certified facility in Haridwar, Uttarakhand. Our quality assurance process ensures every batch meets pharmacopoeial standards before it is released:

• WHO GMP Certified Facility: Manufacturing and quality control conducted under WHO Good Manufacturing Practice guidelines
• In-Process Quality Controls: Analytical testing at multiple stages of synthesis and purification
• Batch Release Testing: Full pharmacopoeial testing panel before any batch is released — identity (IR), assay (HPLC), purity, related substances, residual solvents, water content, microbial limits
• Reference Standards: USP and BP reference standards used for all analytical testing
• Instrument Calibration: All analytical instruments calibrated to traceable standards — HPLC, GC, Karl Fischer titrator, polarimeter, UV-Vis spectrophotometer
• QC Laboratory: Dedicated QC laboratory with qualified analysts. Results reviewed by QA before batch release.

Documentation Provided with Every Batch

For Prednisolone API supplied to Mumbai buyers, we provide the following documentation package as standard:

• Certificate of Analysis (COA): Full batch-specific COA with test results, reference standards used, analyst sign-off, and QA approval
• Material Safety Data Sheet (MSDS): 16-section MSDS compliant with GHS/REACH format
• Certificate of Origin: India-origin certificate for all export shipments
• Pharmacopoeial Compliance Statement: Written confirmation of USP/BP compliance
• Stability Data: Real-time and accelerated stability data available on request
• Drug Master File (DMF): USFDA DMF available for Prednisolone API. Letters of access provided to Mumbai clients for ANDA submissions.
• Certificate of Pharmaceutical Product (CPP): Available on request for export market regulatory submissions
• Regulatory Support: Technical documentation support for regulatory filings in destination markets

Packaging and Delivery to Mumbai

Prednisolone API is packaged in double-layered aluminium foil bags inside fibre drums or HDPE containers. Available packaging sizes for Mumbai clients:

• 100g (sample/trial orders)
• 500g
• 1kg
• 5kg
• 10kg
• 25kg (bulk commercial orders)

Delivery to Mumbai: Road freight 24–48 hours from Haridwar to Mumbai. Air courier same-day or next-day delivery via Blue Dart, FedEx, or DHL. Orders placed before 2 PM dispatched same day. For bulk orders above 25kg, we coordinate with Mumbai-based freight forwarders.

Who We Supply — Prednisolone API in Mumbai and India

• Oral Dosage Form Manufacturers: Companies manufacturing Prednisolone tablets, capsules, and oral liquids (syrups and solutions) for domestic and export markets
• Injectable Manufacturers: Companies producing Prednisolone Sodium Phosphate IV injectables and IM formulations
• Ophthalmic Manufacturers: Companies formulating Prednisolone Acetate ophthalmic suspensions and eye drops
• Topical Manufacturers: Companies producing Prednisolone-based creams, ointments, and lotions
• Export Houses: Mumbai-based pharma exporters supplying finished Prednisolone formulations to African, Southeast Asian, and Latin American markets
• API Distributors: Distributors supplying Prednisolone API to smaller formulation manufacturers across Maharashtra

Minimum Order Quantities and Pricing

• Sample Orders: 100g minimum. COA and MSDS included. Sample cost adjusted against first bulk order.
• Standard Commercial Orders: 1kg minimum. Competitive ex-works pricing available on request.
• Bulk Orders: Volume pricing from 5kg+. Annual supply agreements with committed pricing available.
• Quote Turnaround: Pricing and availability confirmed within 4 business hours of enquiry.

Frequently Asked Questions — Prednisolone API from Mumbai

What grade of Prednisolone API do you supply?

We supply Prednisolone API in USP and BP grades. Both grades are manufactured from the same WHO GMP facility. The COA specifies which pharmacopoeial standard the batch was tested against. EP-compliant batches are available on request with additional testing. Purity is 99%+ (HPLC) for all grades.

Do you have a DMF filed for Prednisolone API?

Yes. We have a USFDA Drug Master File (DMF) for Prednisolone API. Letters of access can be provided to Mumbai clients for referencing the DMF in ANDA/NDA regulatory submissions. Please contact us with your company details and regulatory filing information to initiate the DMF letter of access process.

What is the MOQ for Prednisolone API from Mumbai?

Minimum order quantity for trial/sample purposes is 100g. Standard commercial minimum order is 1kg. For bulk orders of 5kg and above, volume pricing is available. We can supply up to 25kg per order with standard lead times, with larger quantities available with advance planning.

Can you supply Prednisolone Acetate and Prednisolone Sodium Phosphate?

Yes. In addition to Prednisolone base API, we supply Prednisolone Acetate (BP/USP grade, for ophthalmic and topical formulations), Prednisolone Sodium Phosphate (USP grade, water-soluble form for IV injectables and oral solutions), and Prednisolone Hemisuccinate (BP grade, parenteral formulations). Contact us for specifications and pricing for each derivative.

How do I get a price quote for Prednisolone API for delivery to Mumbai?

Email us at [email protected] with the following details: Prednisolone form (base/Acetate/Sodium Phosphate), grade (USP/BP), quantity required, delivery timeline, and your company name and city. Our team will respond with pricing, COA, and lead time within 4 business hours.

Can you support Prednisolone API supply for export formulations?

Yes. We actively supply Prednisolone API to Mumbai-based manufacturers producing finished Prednisolone formulations for export to Africa, Latin America, Southeast Asia, and the Middle East. We provide complete export documentation packages including WHO CPP, DMF letter of access, Certificate of Origin, and country-specific regulatory certificates.

Why Choose Aarise Pharmaceuticals for Prednisolone API in Mumbai

• WHO GMP Certified Manufacturing: Regulatory standards accepted by CDSCO and international regulators
• USP/BP/EP Compliance: Full pharmacopoeial testing against reference standards
• 99%+ HPLC Purity: Consistent high-purity batches verified by independent analytical testing
• USFDA DMF Available: Support for ANDA/NDA submissions in the US market
• Multiple Prednisolone Forms: Base, Acetate, Sodium Phosphate, Hemisuccinate — all from one supplier
• Fast Mumbai Delivery: 24–48 hour road freight, same-day courier available
• Competitive Pricing: Direct manufacturer pricing — no intermediary markups
• Complete Documentation: COA, MSDS, Certificate of Origin, DMF, CPP — everything needed
• Export-Ready Support: Documentation for regulatory filings in 18+ countries
• Dedicated Mumbai Account: Named account manager for fast quotations and order tracking