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Premium Pharmaceutical Gelatin Powder - High Purity for Capsule Manufacturing
Premium Pharmaceutical Gelatin Powder for Capsule Manufacturing

Pharmaceutical Grade Gelatin: The Trusted Excipient for Reliable Drug Delivery and Patient Safety

Pharmaceutical grade gelatin meets global pharmacopeia standards, suitable for capsules and biomedical uses, ensuring reliable drug delivery.

ISO 9001 Certified
FDA Registered
EU Approved

Short Description: BEYOND BIOPHARMA provides ultra-pure Pharmaceutical Grade Gelatin designed to meet the rigorous demands of modern pharmacopeias, including USP, EP, JP, and ChP. Our gelatin is the preferred choice for manufacturers seeking to eliminate dissolution failure and cross-linking issues in hard capsules, softgels, and specialized biomedical applications.

Key Features

  • Global pharmacopeia compliance：Meets or exceeds USP, EP, JP, and ChP standards, with EDQM CEP certification ensuring BSE/TSE safety and full traceability.
  • Advanced anti-cross-linking technology：Engineered for aldehyde-sensitive softgel fills, maintaining stable dissolution profiles throughout 3+ year shelf life even in high-humidity conditions.
  • High-speed machinability for hard capsules：Optimized viscosity and film-forming properties reduce rejection rates to below 0.3% on high-speed lines (Bosch/Shionogi) with superior slip/release.
  • Low-endotoxin biomedical grade：Ultra-pure formulation with endotoxin levels < 10 EU/g, ideal for hemostatic sponges, vaccine stabilization and implantable medical devices.
  • Customizable technical parameters：150–280 Bloom strength (adjustable) and 3.5–5.5 mPa.s viscosity, tailored to resolve production pain points like cross-linking, telescoping and brittleness.
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20 Years of Excellence

Setting New Benchmarks in Pharmaceutical Excipient Quality

In the pharmaceutical industry, the consistency of your excipient is as critical as the potency of your active ingredient. Pharmaceutical Grade Gelatin acts as a protective matrix that ensures the bio-availability and shelf-life of life-saving medications.

At BEYOND BIOPHARMA, we don't just supply raw materials; we provide peace of mind. Our manufacturing process is built on a foundation of compliance and risk control, ensuring that every batch delivers identical mechanical and chemical performance.

Global Regulatory and Safety Certifications

We understand that entering international markets requires impeccable documentation. Our pharma gelatin is backed by:

Full Pharmacopeia Compliance

Guaranteed to meet or exceed USP, EP, JP, and ChP standards.

Stringent Quality Audits

Manufactured in GMP and ISO certified facilities.

BSE/TSE Safety

We hold the EDQM CEP certificate, ensuring 100% traceability and non-infectious sourcing for all bovine and porcine raw materials.

Tailored Solutions for Oral and Specialized Dosage Forms

Our technical team has spent 20 years refining our gelatin to solve the specific pain points of pharmaceutical production lines.

 

Softgel Capsules: Superior Stability Against Cross-linking

Softgels often contain reactive fillers that can lead to "cross-linking," causing the shell to become insoluble over time.

Gummy Candies with high clarity and firmness
  • Advanced Anti-Cross-linking Technology: Our specialized gelatin is engineered for aldehyde-sensitive fills, ensuring that your capsules maintain perfect dissolution profiles throughout their entire shelf life.
  • Optimized Seam Strength: High mechanical resilience reduces the rate of leakers during high-speed encapsulation and speeds up the drying process, directly increasing your ROI.
 

Hard Capsules: High-Speed Machinability and Uniformity

Consistency is the enemy of downtime. For hard capsule manufacturers, our gelatin offers:

Consistency is the enemy of downtime. For hard capsule manufacturers, our gelatin offers
  • Excellent Film-Forming Properties: Ensures uniform wall thickness and a perfect fit between the cap and body.
  • Superior Slip and Release: Specially calibrated viscosity allows for smooth stripping from pins on high-speed machines like Bosch or Shionogi, reducing rejection rates significantly.
 

Biomedical and Injectable Grade (Low-Endotoxin)

For the most sensitive applications, we provide ultra-pure, low-endotoxin gelatin for:

Biomedical and Injectable Grade (Low-Endotoxin)
  • Hemostatic Sponges: Providing a biocompatible, fast-absorbing matrix for surgical use.
  • Vaccine Stabilization: Acting as a high-purity stabilizer for delicate biological molecules.

Proven Success: Real-World Pharmaceutical Case Studies

We take pride in helping our partners overcome complex formulation challenges. Here are a few examples of how BEYOND BIOPHARMA gelatin makes a difference:

 
Case Study 1

Resolving Dissolution Failure in Latin America

Customer Region: Latin America
Product: Multivitamin Softgels

The Challenge

A regional manufacturer was struggling with softgels that failed to disintegrate during stability testing after only six months of storage in high-humidity conditions.

Our Solution

We provided a customized Anti-Cross-linking Pharma Gelatin. By adjusting the molecular weight distribution and specific chemical profile, we eliminated the shell polymerization issue. The customer's product now maintains a 3-year shelf life with stable dissolution, even in tropical climates.

 
Case Study 2

Reducing Rejection Rates in Central Europe

Customer Region: Central Europe
Product: High-Speed Hard Capsule Production

The Challenge

A leading capsule manufacturer was facing high rejection rates (over 4%) due to "telescoping" and brittleness in their hard shells.

Our Solution

After analyzing their production parameters, we supplied a high-Bloom, narrow-viscosity-range Type B Bovine Gelatin. This provided the exact film strength needed for their high-speed lines. Rejection rates dropped to below 0.3%, saving the client thousands in daily material costs.

 
Case Study 3

Supporting Biomedical Innovation in Asia

Customer Region: East Asia
Product: Hemostatic Surgical Sponge

The Challenge

A medical device startup required an ultra-pure gelatin with endotoxin levels strictly below 10 EU/g to meet local regulatory approvals for implantable materials.

Our Solution

BEYOND BIOPHARMA utilized its specialized purification line to produce a Low-Endotoxin Medical Grade Gelatin. With our comprehensive technical dossier and consistent purity, the customer successfully passed their clinical trials and secured market approval in record time.

Technical Specifications Overview

Every batch of BEYOND BIOPHARMA Pharmaceutical Grade Gelatin comes with a comprehensive Certificate of Analysis (COA) and global compliance documentation.

Items Specifications

Bloom Strength

150 – 280 Bloom (Customizable)

Viscosity (6.67% at 60°C)

3.5 – 5.5 mPa.s

Standards Compliance

USP / EP / JP / ChP

Endotoxin Level

Available < 10 EU/g for Medical Grade

Transparency

≥ 90%

Shelf Life

3 - 5 Years

Your Strategic Partner in Pharmaceutical Innovation

At BEYOND BIOPHARMA, we believe that a high-quality excipient is the foundation of patient trust. Our technical experts support your scaling or formulation challenges with samples, stability data, and regulatory documentation.

Ready to enhance your product stability and meet pharma-grade standards?

Request a Pharma Grade Sample Download Regulatory Documentation Contact Our Technical Team