KRTL Holding Group Inc. (OTC: KRTL) is proud to announce that its wholly owned subsidiary, KRTL Biotech Inc., has successfully acquired its FDA Facility Establishment Identifier (FEI) number and National Drug Code (NDC) registration. These critical regulatory milestones position KRTL Biotech as a compliant and competitive player in the pharmaceutical manufacturing industry.
The acquisition of the FDA FEI number formally integrates KRTL Biotech's facility into the U.S. Food and Drug Administration's (FDA) regulatory framework. This designation signifies adherence to statutory and regulatory mandates, including Good Manufacturing Practices (GMP), ensuring consistency, safety, and efficacy in pharmaceutical production.
The NDC registration adds another layer of operational credibility by enabling precise product identification within the U.S. healthcare system. This unique coding system enhances supply chain transparency, supports comprehensive traceability, and aligns with industry demands for robust oversight. These certifications collectively underscore KRTL Biotech's dedication to regulatory compliance, operational excellence, and scaling production to meet the growing demands of the pharmaceutical sector.
Laying the Groundwork for Operational Excellence
"Achieving FDA FEI and NDC certification is a pivotal milestone for KRTL Biotech as we advance our capabilities within the pharmaceutical sector," said Dan Bishop, Global Development Officer of KRTL Biotech. "These certifications are integral to our operational framework, enabling us to establish a compliant manufacturing base and uphold the stringent standards required for regulatory adherence."
Strategic Implementation and Future Direction
With these certifications, KRTL Biotech is setting the stage for a manufacturing infrastructure designed to meet stringent regulatory requirements and align with industry best practices. Advanced quality management systems are being implemented to ensure operational integrity and readiness for regulatory audits and inspections.
Additionally, KRTL Biotech is leveraging its extensive global network to enhance manufacturing and distribution capabilities through strategic collaborations. By engaging with international partners, KRTL Biotech seeks to address diverse market needs, ensuring that its pharmaceutical offerings are both regionally relevant and globally impactful. These initiatives reflect a commitment to regulatory compliance, operational excellence, and fostering international cooperation to meet critical healthcare challenges.
For more information about KRTL Biotech Inc., please visit the FDA's DECRS database and search for KRTL Biotech:
About KRTL Biotech Inc.:
KRTL Biotech Inc., a wholly owned subsidiary of KRTL Holding Group Inc., specializes in pharmaceutical registration, regulatory compliance, and the development of pharmaceutical products and APIs. KRTL Biotech is dedicated to innovation and operational excellence in the pharmaceutical industry.
About KRTL Holding Group, Inc.:
We are interested in having a competitive edge in the marketplace, through mergers & acquisitions, collaborations, and strategic alliances with specific partners.
KRTL Holding Group Inc.is a holding company which operates through its wholly owned subsidiaries, KRTL Biotech, Inc. and KRTL International Corp. These subsidiaries have evolved to focus on distinct industries, yet they intricately intertwine, forming the bedrock of the KRTL brand. This strategic synergy empowers KRTL Holding Group to actively pursue investment opportunities and forge invaluable partnerships, ultimately enhancing shareholder value.
Additional information on KRTL is available online at www.krtlholding.com and www.krtl-icc.com and www.krtlbiotech.com.
The information contained herein includes forward-looking statements. These statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
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