Description

Understanding BSE/TSE-Free Gelatin

BSE (Bovine Spongiform Encephalopathy) and TSE (Transmissible Spongiform Encephalopathies) are diseases associated with animal-derived materials. Although the risk is extremely low, pharmaceutical and nutraceutical manufacturers must eliminate any possibility of contamination in their products.

BSE/TSE-free gelatin is produced from raw materials sourced exclusively from healthy animals that have passed veterinary inspection and originate from regions officially recognized as BSE/TSE-free.

Using BSE/TSE-free capsules is not just a regulatory requirement — it is also a powerful signal of safety and responsibility to your customers.

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Why BSE/TSE-Free Capsules Are Essential

Compliance with Global Regulations

Most regulatory authorities, including the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and the World Health Organization (WHO), require that gelatin used in pharmaceuticals be BSE/TSE-free.

By using capsules from Medico Merim, your products automatically meet these global standards.

Consumer Confidence and Brand Protection

Health-conscious consumers and corporate buyers increasingly demand proof of safe sourcing. BSE/TSE-free certification provides this assurance, strengthening your brand’s image as a responsible and trustworthy manufacturer.

Supply Chain Transparency

Using certified gelatin ensures full traceability of raw materials, making audits, quality inspections, and export processes smoother and faster.

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Medico Merim — Your Trusted Manufacturer

Medico Merim is a specialized manufacturer of pharmaceutical-grade hard gelatin capsules based in Türkiye. We serve pharmaceutical, nutraceutical, and dietary supplement companies worldwide with consistent quality, reliable supply, and strong compliance support.

GMP-Certified Production Facilities

All BSE/TSE-free capsules are produced in our GMP-compliant facilities under cleanroom conditions. Every step is validated, documented, and traceable to ensure complete regulatory compliance.

Certified Pharmaceutical-Grade Gelatin

We use only gelatin from certified BSE/TSE-free sources that are audited and approved by international regulatory bodies. Each batch is accompanied by veterinary and health certificates confirming its disease-free status.

Full Documentation Support

Each shipment comes with:

• Certificate of Analysis (COA)

• BSE/TSE-free declaration from raw material suppliers

• Halal and Kosher certificates upon request

• ISO-compliant production records and stability data

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Technical Specifications

• Sizes: 000, 00, 0, 1, 2, 3, 4

• Moisture content: 13–16%

• Disintegration time: <15 minutes

• Shelf life: 3–5 years under recommended storage

• Packaging: Bulk pharmaceutical-grade containers with protective liners

• Compatible with powders, granules, pellets, and micro-tablets

These capsules are engineered for efficient use on high-speed filling machines while maintaining stability during storage and transport.

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Applications and Industries

BSE/TSE-free gelatin capsules are used by leading companies in:

• Prescription pharmaceuticals

• Over-the-counter medicines

• Nutraceutical and dietary supplements

• Herbal and botanical products

• Clinical trial formulations

• Export products requiring certification for customs clearance

They are essential for any product aiming to enter regulated international markets.

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Customization Options

Medico Merim combines safety with flexibility. While all our capsules are BSE/TSE-free by default, you can customize:

• Capsule size (000 to 4)

• Color (white, transparent, colored, two-tone, metallic, pearl)

• Printing (logo, product codes, brand name)

• Surface finish (glossy, matte, pearl)

• Moisture specifications adjusted for different climates

This allows you to combine certified safety with strong brand identity.

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Why Choose Medico Merim

Partnering with Medico Merim for BSE/TSE-free capsules gives you clear advantages:

• Dedicated manufacturer of pharmaceutical-grade capsules

• 100% certified BSE/TSE-free gelatin

• High production capacity and consistent supply

• Flexible minimum order quantities

• Fast lead times and efficient export logistics from Türkiye

• Full technical and regulatory documentation support

• Responsive communication and long-term partnership approach

We are more than a supplier — we are your strategic manufacturing partner focused on quality, safety, and reliability.

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Quality and Safety Commitment

Quality is the foundation of Medico Merim. We implement strict quality control at every production stage, including raw material testing, in-process checks, and final product verification.

Our operations comply with international pharmacopoeia standards, and our staff receives continuous GMP training. This ensures every capsule meets the highest global safety requirements.

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Sustainable and Ethical Manufacturing

Medico Merim is committed to sustainability and ethical sourcing. Our gelatin is sourced only from certified suppliers who follow strict animal welfare and traceability standards. We also prioritize energy efficiency, waste reduction, and environmentally responsible production methods.

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Long-Term Partnership Approach

We view every client as a long-term partner. Our team collaborates closely with your R&D, procurement, and production departments to deliver capsule solutions tailored to your exact needs.

We support your business with transparent communication, consistent delivery, and comprehensive documentation — helping you enter new markets and maintain regulatory compliance effortlessly.

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Conclusion: Safety You Can Trust

BSE/TSE-free gelatin capsules are essential for regulatory compliance, consumer trust, and global market access. They protect your brand, ensure product safety, and reflect your commitment to quality and responsibility.

As a trusted manufacturer, Medico Merim combines pharmaceutical expertise, certified raw materials, and advanced GMP production to deliver BSE/TSE-free capsules that meet the highest international standards.

Choose safety and trust — choose BSE/TSE-Free Gelatin Capsules from Medico Merim