Pharmaceutical Ingredients
Precision Chemistry.
Advanced Drug Delivery.
Elevating pharmaceutical formulations through high-purity excipients, functional ingredients, and specialized ethoxylation expertise.
At Rossari Biotech Limited, we synthesize deep chemical expertise with stringent quality standards to empower pharmaceutical manufacturers worldwide. From optimizing bioavailability to enabling targeted release profiles, our advanced portfolio delivers the structural reliability required for modern dosage forms.
Whether y ou are dev eloping complex oral solids, stable topicals, or sensitive biologics, Rossari Biotech Limit ed prov ides t he regulat ory assurance, int egrated manufacturing scale, and technical agilit y y our pipeline demands.
WHY ROSSARI PHARMA?
Partnering with formulators to bridge the gap between complex chemistry and regulatory compliance.
Integrated Manufacturing Scale
Our core leadership in ethoxylation chemistry and PEG synthesis allows us to maintain absolute control over molecular weight distribution, impurity profiles, and batch-to-batch consistency.
Regulatory Excellence Global Compliance
Mitigate risk with audit-ready documentation and top-tier certifications-
- • USDMF & CEP Registration (Type II)
- • WHO GMP Certification
- • EXCiPACT Certification
- • Comprehensive Pharmacopoeial Compliance (USP/EP/BP/IP)
Global Supply Chain Agility
With a robust international distribution network, Rossari seamlessly supports commercial-scale pharmaceutical manufacturing across India, LATAM, MENA, Europe, and Asia.
Proactive Application Support
We don't just supply ingredients; we co-develop solutions. Our technical teams assist with formulation troubleshooting, excipient replacement studies, and comprehensive regulatory filing documentation.
PRODUCT PORTFOLIO
High-purity functional excipients engineered for stability, solubility, and performance.
Pharmaceutical Grade PEG API for Osmotic Laxative Applications.
Engineered under pristine, validated conditionsto meet the most rigorous global standards. ROSSHUG™ PEG 3350 functions directly as an Active Pharmaceutical Ingredient (API) for both over-the-counter (OTC) and prescription osmotic laxative formulations.
- Regulatory Status: Active Type II USDMF
- Applications: Prescription laxatives, OTC bowel prep kits, and therapeutic oral solids.
High-Purity Liquid and Solid PEGs for Diverse Dosage Forms.
A comprehensive range of pharmaceutical-grade PEGs tailored to modify viscosity, act as hydrophilic bases, or serve as plasticizers.
Available Grades: PEG 300, PEG 400, PEG 600, PEG 800, PEG 1000, PEG 1450, PEG 1500, PEG 1540, PEG 3350, PEG 4000, PEG 6000, PEG 8000, PEG 10000
Primary Applications: Hydrophilic bases for ointments, solvent vehicles for soft gels, and tablet coating plasticizers.
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Non-Ionic Surfactants for Enhanced Solubilization and Stabilization.
Optimized to stabilize emulsions, prevent protein aggregation, and enhance dissolution rate of poorly soluble molecules.
- Available Grades: Polysorbate 20, 40, 60, 80.
- Specialty: HP Grades (Injectable Grade) for critical parenteral and biologic applications.
- Primary Applications: Micellar solubilization, parenteral drug delivery systems, oral liquids, and biologicsstabilization.
Advanced Lipid-Based Excipients for Challenging APIs.
High-performance amphiphilic vehicles designed to overcome bioavailability hurdles in poorly soluble drug profiles.
Available Grades: PEG 35 Castor Oil, PEG 40 Hydrogenated Castor Oil, RH40 Equivalents
Specialty Segment: High Purity Injectable Grade PEG 35 Castor Oil
Primary Applications: Self-Emulsifying Drug Delivery Systems (SEDDS/SMEDDS), soft gel matrix fills, and hydrophobicdrug solubilization.
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Hydrophobic Emulsifiers for Reliable Topical Systems.
Versatile lipophilic surfactants designed to produce stable, elegant topical and semisolid emulsions.
Available Grades: Span 20, Span 40, Span 60, Span 80.
Primary Applicat ions:W/O emulsions, topical creams, therapeutic ointments, and medicated lotions.
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Methacrylic Acid Copolymers for Modified Release Profiles.
Advanced polymer systems engineered to protect active ingredients, mask unpleasant tastes, and precisely control site-specific drug release.
Available Grades:ROSSCOAT L30D, ROSSCOAT L100, ROSSCOAT L100D, ROSSCOAT S100.
Primary Applicat ions: Enteric coating, delayed/sustained release matrices, and taste masking for paediatric/geriatric oral solids.
Email Our Team NowBroad-Spectrum Microbe Control for Extended Shelf Life.
High-purity preservation agents that ensure product safety and microbiological stability throughout the product lifecycle.
Available Grades: Phenoxyethanol, Benzalkonium Chloride, Hexanediol.
Primary Applications: Oral liquid formulations, topical dermatological, and personal care crossover applications.
Email Our Team NowSolutions by Dosage Form
Matching precision chemistry to your specific delivery format.
| Target Dosage Form | Recommended Ingredients |
|---|---|
| Tablets | ROSSCOAT Polymers (Enteric/Delayed Release), ROSSPEG (Plasticizers) |
| Capsules | ROSSPEG Solid Grades (Matrix binders and fillers) |
| Oral Liquids | ROSSPEG Liquid Grades (Solvents), ROSSORB Polysorbates (Solubilizers) |
| Topicals & Semisolids | ROSSPAN Sorbitan Esters, Ceteareth, Glyceryl Monostearate (GMS) |
| Soft gel Capsules | ROSSCAS Castor Oil Derivatives, ROSSPEG (Hydrophilic vehicles) |
| Nutraceuticals | ROSSORB Polysorbates, ROSSCAS (Bioavailability enhancers) |
| Injectables & Parenteral | ROSSORB HP Grades, High Purity Injectable ROSSCAS |
DOCUMENTATION & COMPLIANCE
Full transparency to accelerate your regulatory approvals.
We eliminate regulatory bottlenecks by providing a complete, audit-ready data package for every batch. Our documentation suite ensures seamless compliance with international health authorities
Certificate of Analysis (COA) & Technical Data Sheets (TDS)
Compliant Safety Data Sheets (SDS)
Comprehensive GMP, CTD & EXCiPACT Audit Documentation
BSE/TSE Free & Allergen Statements
Residual Solvent Validation & Elemental Impurity Profiles (ICH Q3D)
Robust Change Control Support
INNOVATION PIPELINE
Anticipating the formulation challenges of tomorrow.
Our upcoming port folio expansion includes:
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Poloxamers
High-purity Poloxamer 188 and Poloxamer 407 for advanced solubilization and cell-culture stabilization.
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Carbomers
High-viscosity polymers for rheologymodification and controlledrelease topicals.
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Sodium Stearyl Fumarate
Highperformance, hydrophilic tablet lubricant designed to replace magnesium stearate in sensitive formulations.
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Specialized Lipid Excipients
Supporting lipid nanoparticle (LNP)systems and advanced bioavailability enhancement.
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Next-Gen Modified Release Technologies:
Tailored smart polymers for complex chronotherapeutic delivery.