Bilastine API 25kg Drums | GMP Bulk API Manufacturer India

Bilastine API 25kg Drums | GMP Bulk API Manufacturer India

Last Updated: January 2026

Why Packaging Size Matters: Bilastine API in 25kg Drums

Bilastine API supplied in 25kg GMP-compliant drums offers optimal volume efficiency, reduced contamination risk, regulatory traceability, and cost-effective logistics for global formulation manufacturers.

Bio-Synth, a WHO-GMP–certified API manufacturer based in Hyderabad, India, supplies Bilastine API in standardized and customizable packaging formats aligned with global regulatory and export requirements.

 

Introduction: Why API Packaging Size Is a Strategic Decision

In today’s competitive global pharmaceutical market, bulk procurement of APIs goes beyond pricing. Buyers must evaluate:

• Regulatory compliance
• Packaging integrity
• Batch traceability
• Scalability for commercial production

When sourcing Bilastine API in 25kg drums, partnering with a trusted manufacturer like Bio-Synth delivers strategic advantages for allergy drug manufacturers, R&D organizations, and finished dosage exporters worldwide.

With 80+ years of pharmaceutical manufacturing excellence, Bio-Synth specializes in high-quality APIs and intermediates across antihistamines, anti-TB, cardiovascular, antipsychotic, and anti-diabetic segments.

This article covers:

• Why 25kg drum packaging matters
• Regulatory and quality considerations
• Global API sourcing trends
• How Bio-Synth ensures packaging integrity and compliance

 

What Is Bilastine, and Why Is Bulk Packaging Essential?

Bilastine is a second-generation H1 antihistamine widely prescribed for:

• Allergic rhinitis
• Chronic urticaria

Its non-sedating profile and strong safety margin make it a preferred molecule in many regulated and emerging markets.

Why Choose Bulk Packaging Like 25kg Drums?

• Volume Efficiency: Ideal for large-batch formulation and continuous manufacturing
• Reduced Handling Risk: Superior protection against moisture, light, and contamination
• Optimized Global Transport: Compatible with international API shipping norms
• Regulatory-Friendly: GMP-compliant sealing, labeling, and batch traceability

 

API Manufacturing in India: Why Bio-Synth Is the Strategic Partner You Need

India remains a global leader in API manufacturing due to robust infrastructure, cost efficiency, and regulatory maturity. However, not all suppliers offer the same depth of reliability.

What Sets Bio-Synth Apart

✔ WHO-GMP–Certified Manufacturing Facilities
All production is carried out at WHO-GMP–compliant plants in Hyderabad, ensuring stringent quality control and audit readiness.

✔ Eight Decades of Pharmaceutical Heritage
Established in 1943, Bio-Synth’s legacy supports mature quality systems, validated processes, and continuous improvement.

✔ Expertise Across High-Demand Therapeutic Segments

Therapeutic Area	Flagship APIs
Anti-TB	Bedaquiline, PAS Sodium
Antihistamines	Bilastine
Cardiovascular	Carvedilol
Antipsychotic	Amisulpride
Anti-Diabetic	Empagliflozin, Dapagliflozin

Whether you need Bilastine API in 25kg drums or smaller packs for R&D and pilot batches, Bio-Synth offers customized packaging formats without compromising GMP standards.

 

How Bio-Synth Ensures API Quality and Consistency

Maintaining high purity, batch integrity, and regulatory compliance is critical—especially for bulk APIs.

In-Process Controls & Final Testing

Each Bilastine batch undergoes comprehensive QC testing, including:

• API assay
• Impurity profiling (ICH Q3A/B)
• Residual solvents (GC analysis)
• Heavy metals (ICP-MS)
• Microbial limits testing

Regulatory Documentation Supplied

• Certificate of Analysis (CoA)
• Material Safety Data Sheet (MSDS)
• GMP compliance certificates
• CEP / DMF regulatory support (on request)

 

Bilastine Packaging Process Flow: 25kg Drum Specification

API Packaging Workflow

1. Final drying
2. QA batch clearance
3. Primary packaging: Double-layer sealed LDPE bags
4. Secondary packaging: HDPE or UN-approved fiber drums (25kg)
5. GMP-compliant labeling & serialization
6. Thermo-regulated storage & dispatch

All 25kg drums are tamper-evident and compliant with DGFT, UN, and IATA shipping norms for pharmaceutical APIs.

 

Regulatory Considerations for API Procurement from India

1. Import–Export (EXIM) Documentation

Bio-Synth provides:

• Commercial invoice
• Packing list
• Bill of lading
• Certificate of origin
• GMP & ISO certificates

2. GMP Compliance Audits

We support:

• On-site plant audits
• Virtual inspections
• Third-party and government audits

3. Registration & Technical Dossiers

• CTD-format technical dossiers
• Drug Master Files (DMFs)
• Quality and supply agreements

 

Key Trends in Global API Procurement

API Price Volatility

Raw material fluctuations and global trade conditions drive pricing uncertainty. Bio-Synth mitigates this through long-term supply agreements and cost-control strategies.

Preferential Trade Agreements

Many regions (Africa, ASEAN, Latin America) benefit from reduced import duties when sourcing APIs from India.

Rising Demand for Custom Synthesis

R&D and formulation companies increasingly require custom intermediates and pilot-scale APIs, an area where Bio-Synth’s in-house R&D and scale-up capabilities excel.

 

Build a Long-Term Advantage with Bio-Synth

When sourcing Bilastine API in 25kg drums, compliance, consistency, and trust are non-negotiable.

Why Global Buyers Choose Bio-Synth

• 80+ years of pharmaceutical expertise
• Customizable API packaging aligned with export SOPs
• Rapid regulatory and technical support
• Strong export presence across Europe, Africa, ASEAN, and Latin America

Bio-Synth is not just a supplier—it is a long-term pharmaceutical ingredient partner.

Contact Bio-Synth today to request samples, bulk quotes, or full technical dossiers.

 

Related Bulk APIs You May Be Interested In

• Bedaquiline API – Anti-TB
• Amisulpride – Mental health formulations
• Empagliflozin & Dapagliflozin – Anti-diabetics
• Carvedilol API – Cardiovascular management

 

Frequently Asked Questions (FAQs)

1. What is the shelf life of Bilastine API in 25kg drums?

A minimum shelf life of 36 months is supported by validated ICH stability studies when stored under recommended conditions.

2. Is the packaging customizable?

Yes. In addition to 25kg drums, Bio-Synth offers 1kg, 5kg, and 10kg packs for R&D, pilot, and clinical development.

3. Can Bio-Synth support regulatory filings in the EU or Latin America?

Yes. Bio-Synth provides DMFs and CTD-format dossiers to support registrations in EU, Latin America, and other global markets.

4. Are Bio-Synth’s facilities ISO certified?

Yes. Along with WHO-GMP, all manufacturing units are ISO 9001:2015 certified.

 

Final Thoughts: Reliable Bulk API Supply Starts with the Right Partner

API sourcing is foundational to pharmaceutical success.

With Bio-Synth, you gain:

• GMP-compliant manufacturing
• Predictable bulk supply
• Regulatory confidence
• Commercial scalability

Ready to secure Bilastine API in 25kg drums from a WHO-GMP–certified manufacturer? Request a consultation or technical datasheet today.