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Jul 14, 2026, 12:00 ET ACROBiosystems Obtains PMDA Material Suitability Confirmation for GMP-grade IL-15, Ensuring Reliable Quality and Strengthening the Biopharmaceutical Approval Process
Japan.In addition to Japan, ACROBiosystems also possesses complete regulatory support capabilities in major global markets: all of its GMP products undergo DMF filing with the FDA in the United States; in China and Europe, where official agencies have yet to open pathways for GMP raw material filings, the company
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Jul 08, 2026, 09:38 ET Porton Advanced's UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance
Evaluation and Research (CBER), under Drug Master File (DMF) #32973. This milestone further strengthens Porton Advanced's position in the rapidly evolving exosome therapeutics market. With the DMF filing, sponsors advancing exosome programs can reference DMF #32973 in their own regulatory submissions, significantly
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Jul 08, 2026, 09:00 ET Porton Advanced's UC-MSCs Cell Bank for Exosome Manufacturing Receives U.S. FDA Drug Master File (DMF) Acceptance
Evaluation and Research (CBER), under Drug Master File (DMF) #32973. This milestone further strengthens Porton Advanced's position in the rapidly evolving exosome therapeutics market. With the DMF filing, sponsors advancing exosome programs can reference DMF #32973 in their own regulatory submissions, significantly
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Jun 09, 2026, 09:00 ET REPROCELL Receives Commercialization Award from Maryland Stem Cell Research Fund to Advance Universal, Hypoimmune iPSC Platforms
technology, the new lines will be manufactured in REPROCELL's state-of-the-art U.S. cleanrooms, supported by the generation of a regulatory Drug Master File (DMF).Additionally, the program will advance the development of a modular "landing pad" platform. This technology enables the precise insertion of
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Apr 28, 2026, 09:11 ET C-Ray Therapeutics Receives FDA Acceptance of Type II Drug Master File for Copper-64 (Cu-64)
II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been listed as active by the U.S. Food and Drug Administration (FDA) under DMF No. 43568. The DMF is now available for reference by radiopharmaceutical developers worldwide in support of IND and NDA submissions. Cu-64:
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Apr 14, 2026, 09:34 ET Apotex Announces FDA Approval of First Generic Infuvite® Adult Injection (Single Dose Vial and Pharmacy Bulk package) with 180‑Day CGT Exclusivity for the Pharmacy bulk package in Partnership with Orbicular and Gland Pharma
emulsion‑based formulation architecture, advanced analytical characterization, and stability and compatibility engineering, culminating in successful DMF adequacy for 13 multivitamins aligned with evolving regulatory expectations. Gland Pharma contributed commercial manufacturing readiness through its
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Apr 01, 2026, 07:00 ET Cardinal Health expands Actinium-225 production capacity to support growing demand for novel cancer therapies
company's Center for Theranostics Advancement (CTA) in Indianapolis, Indiana. The addition of a high-capacity production line to its Drug Master File (DMF) will substantially increase Cardinal Health's supply of cGMP-compliant Ac-225 for use in investigational therapeutic drug products and future commercial
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Mar 03, 2026, 09:00 ET REPROCELL Launches GMP Master Cell Bank Manufacturing for Clinical iPSCs
platform, the StemRNA Clinical iPSC Seed Clone – LLF-34-F3, derived from US sourced donor material, is supported by an active FDA Drug Master File (DMF). This clone has been expanded into a GMP MCB using FDA-compliant closed system processes. This off-the-shelf GMP iPSC MCB is now available for commercial
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Mar 03, 2026, 09:00 ET REPROCELL Launches GMP Master Cell Bank Manufacturing for Clinical iPSCs
platform, the StemRNA Clinical iPSC Seed Clone – LLF-34-F3, derived from US sourced donor material, is supported by an active FDA Drug Master File (DMF). This clone has been expanded into a GMP MCB using FDA-compliant closed system processes. This off-the-shelf GMP iPSC MCB is now available for commercial
More news about: REPROCELL USA
Mar 03, 2026, 09:00 ET REPROCELL startet GMP Master Cell Bank-Produktion für klinische iPSCs
Plattform wird der StemRNA Clinical iPSC Seed Clone - LLF-34-F3, der aus US-amerikanischem Spendermaterial stammt, durch eine aktive FDA Drug Master File (DMF) unterstützt. Dieser Klon wurde zu einem GMP-MCB erweitert, das FDA-konforme geschlossene Systemprozesse verwendet. Dieses GMP-iPSC-MCB ist jetzt für
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Mar 03, 2026, 09:00 ET REPROCELL lanza la fabricación de bancos de células maestras GMP para iPSC clínicas
semilla StemRNA Clinical iPSC, LLF-34-F3, derivado de material de donantes de origen estadounidense, cuenta con el respaldo de un archivo maestro de medicamentos (DMF) activo de la FDA. Este clon se ha convertido en GMP MCB mediante procesos de sistema cerrado que cumplen con la FDA. Este GMP iPSC MCB ya está disponible
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Mar 03, 2026, 09:00 ET REPROCELL lance la fabrication de banques de cellules maîtresses conformes aux BPF pour les iPSC cliniques
le clone de semence clinique iPSC StemRNA - LLF-34-F3, dérivé d'un matériel de donneur provenant des États-Unis, est soutenu par un Drug Master File (DMF) actif de la FDA. Ce clone a été transformé dans une MCB conforme aux BPF à l'aide de procédés en circuit fermé répondant aux normes de la FDA. Cette
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Jan 25, 2026, 19:00 ET Landmark FDA Move: First Quality Control Protocol for Mesenchymal Stromal Cells (MSCs) Sets New Therapeutic Standard
China, Jan. 25, 2026 /PRNewswire/ -- In a landmark move for the cell therapy industry, a Device Master File (DMF) describing the first dedicated quality control standard for Mesenchymal Stromal Cells (MSCs) was accepted by the U.S. Food and Drug Administration (FDA).
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Jan 25, 2026, 19:00 ET Langkah Bersejarah FDA: Protokol Pengendalian Mutu Pertama untuk "Mesenchymal Stromal Cells" (MSC) Jadi Standar Terapi Baru
TIANJIN, Tiongkok, 26 Januari 2026 /PRNewswire/ -- Sebagai sebuah momen bersejarah bagi industri terapi sel, Device Master File (DMF) yang memaparkan standar pengendalian mutu khusus Mesenchymal Stromal Cells (MSC) pertama telah diterima oleh Badan Pengawas Obat dan Makanan Amerika
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Jan 08, 2026, 13:31 ET Akadeum Life Sciences to Highlight How Microbubbles Enable Rapid Cell Therapy Manufacturing for Larger Patient Populations at Biotech Showcase 2026
Akadeum submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration for its GMP BACS™ Microbubble Cell Separation products, marking a key regulatory milestone for the platform. The DMF reflects Akadeum's adherence to stringent ancillary material standards
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Dec 08, 2025, 08:06 ET Nootropics Depot Releases Black Ginger Market Potency Data
contain the highest measured percentage of 5,7-dimethoxyflavone (5,7-DMF) among evaluated products. The internal market research compared leading black ginger supplements and found that Nootropics Depot's extract delivers more than double the 5,7-DMF content of the next closest competitor.
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Nov 25, 2025, 05:01 ET Generic Drugs Market Size to Worth USD 898 Billion by 2035, at a CAGR of 5.75% | Research by Vantage Market Research
visibility & API sourcing resilienceBuild advanced GMP-compliant manufacturing with automated QA/QCExpand regulatory expertise in ANDA, DMF, biosimilar & global dossier filingsEnhance R&D for difficult-to-formulate molecules and long-acting productsEstablish strategic
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Nov 21, 2025, 03:01 ET HRV Pharma and MetroChem Forge Strategic CDMO Alliance to Fast-Track High-Value NCE-1 API Development
NCE-1 opportunitiesEnd-to-end GMP manufacturing, validation, and supply for regulated and semi-regulated marketsGlobal regulatory DMF filings (US, EU, LATAM, MENA & APAC) with shared technical dossiersA long-term, pipeline-led framework covering novel CNS, metabolic and
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Nov 18, 2025, 07:30 ET Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation
buoyant cell separation, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its GMP BACS™ Microbubble Cell Separation products. The DMF represents Akadeum's strong commitment to delivering high-quality cell isolation products for
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Oct 20, 2025, 16:28 ET CaseBioscience® Launches CaseBio™ Culture and CaseBio™ Handling Media at ASRM 2025 After FDA 510(k) Clearance and Clinical Evaluation
strengthening CaseBioscience's regulatory foundation in North America. New FDA submissions are also in progress, including a Drug Master File (DMF) for CaseCryo® CTG, the company's clinical-grade cryopreservation solution for stem cells, and for CaseStor® HSS, a specialized hypothermic
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Oct 09, 2025, 03:30 ET MSN Laboratories Launches Affordable JAK Inhibitors to Boost Access for Indian Patients
previously launched close to 50 first-time molecules in India. The company holds the No. 1 position in Active Pharmaceutical Ingredient (API) US DMF filings. "The introduction of Upadoz reflects our commitment to bringing affordable bioequivalent medications to alleviate
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Sep 30, 2025, 10:00 ET Sony Electronics Expands the G Master Series with the Versatile FE 100mm F2.8 Macro GM OSS
allow precise and intuitive focus adjustments for a variety of macro photography scenes, the lens offers three focus-dedicated features: a "Full-time DMF switch" enables instant MF (manual focus) by rotating the focus ring, even in AF (autofocus) mode; the "Focus Mode switch" allows instant switching between
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Sep 16, 2025, 22:30 ET Kexing Biopharm's Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes Registered with FDA DMF
announced that its investigational Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes has successfully completed a Type II Drug Master File (DMF) registration with the U.S. FDA. Exosomes, as a next-generation bioactive carrier, boast unique advantages such as low immunogenicity, strong
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