JYMed Peptide is pleased to announce that Hubei JXBio Pharmaceutical Co., Ltd, its peptide API manufacturing site, has received Korean Drug Master File (K-DMF) registration for Teriparatide Acetate from South Korea’s Ministry of Food and Drug Safety (MFDS).

The registration marks an important regulatory development for JYMed and strengthens the company’s ability to support pharmaceutical partners in the South Korean market.

Registration details

• API: Teriparatide Acetate
• CAS number: 99294-94-7
• K-DMF registration number: 수258-61-ND
• Regulatory authority: Ministry of Food and Drug Safety, South Korea
• Manufacturing site: Hubei JXBio Pharmaceutical Co., Ltd

What does the K-DMF registration mean?

A Drug Master File provides regulatory authorities with detailed information about the manufacturing process, controls, quality standards, and facilities associated with an active pharmaceutical ingredient.

The K-DMF registration confirms that the quality dossier for JYMed’s Teriparatide Acetate API has been accepted by the South Korean regulatory authority. Korean finished-dosage-form manufacturers may reference this dossier when submitting relevant applications for pharmaceutical products containing the API.

This creates a regulatory foundation for future cooperation with pharmaceutical companies developing or commercializing teriparatide products in South Korea.

The registration applies to the active pharmaceutical ingredient and does not constitute approval of a finished drug product. When the API is referenced in a finished-product application, it remains subject to the applicable linked review and product-specific regulatory requirements.

About Teriparatide Acetate

Teriparatide is the biologically active 1-34 amino acid fragment of human parathyroid hormone. It is an anabolic agent used in the treatment of osteoporosis in patients at high risk of fracture.

When administered intermittently, teriparatide stimulates osteoblast activity and supports new bone formation. Its peptide structure requires careful control throughout synthesis, purification, analytical characterization, and manufacturing to ensure consistent identity, purity, and quality.

These requirements make scientific expertise, robust quality systems, and reliable manufacturing processes essential throughout the API lifecycle.

Supporting pharmaceutical partners in South Korea

For JYMed’s partners, the K-DMF registration provides an established regulatory reference for Teriparatide Acetate API in South Korea.

It can support discussions with finished-dosage-form manufacturers seeking qualified peptide API suppliers with the technical capabilities and regulatory documentation required for product development and registration.

The achievement also expands JYMed’s international peptide API portfolio and reflects the company’s continued investment in regulatory readiness across global markets.

Integrated peptide development and manufacturing

JYMed provides peptide development and manufacturing services across the product lifecycle, from early research and process development to scale-up and commercial manufacturing.

Its integrated capabilities include peptide synthesis, process optimization, purification, analytical development, quality control, regulatory support, and commercial-scale production. This structure allows JYMed to work closely with pharmaceutical partners as projects progress from development to market supply.

The Teriparatide Acetate K-DMF registration is a meaningful addition to these capabilities and reinforces JYMed’s commitment to dependable peptide manufacturing for regulated markets.

To learn more about JYMed’s Teriparatide Acetate API or discuss a peptide API or CDMO project, contact our team.