Please Wait
Applying Filters...
menu
    • menu
    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

    Virtual Booth

    Contact Supplier

    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

    Virtual Booth

    Contact Supplier

    pharmacompass-1-m-2026-01-12

    Virtual Booth

    An Enquiry

    LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.https://marketing.lgmpharma.com/LGM-CDMO

    Virtual Booth

    Contact Supplier

    Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

    Virtual Booth

    Contact Supplier

    pharmacompass-2-2026-02-09

    Virtual Booth

    An Enquiry

    Menu

    Jin Dun Medical

    EVENTS

    • Webinars & Exhibitions

    DIGITAL CONTENT

    ACTIVE PHARMA INGREDIENTS

    PharmaCompass

    Filters

    clear-filterReset all filters
    Left Arrow
    Right Arrow

    Digital content

    Create Content with PharmaCompass, ask us

    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    Expert Take on CEP 2.0: A New Era of Transparency in Pharmaceutical Regulation

    micExpert Take on CEP 2.0: A New Era of Transparency in Pharmaceutical Regulation

    At the recent EDQM conference “Certified for Success: Using the CEP Procedure to Elevate Quality and Drive Trust,” regulatory leaders gathered to discuss one of the most significant shifts in European pharmaceutical oversight recently– the transition to CEP 2.0. In the following article, Karina Boszko, Head of Global Regulatory Affairs and Customer Technical Service at Polpharma API, shares her perspective on the new framework and its impact on transforming regulatory strategies for manufacturers worldwide. A strategic shift beyond just compliance. CEP 2.0 is more than a routine update. It represents a fundamental change in how pharmaceutical companies approach transparency, lifecycle management, and international expansion. Rather than focusing solely on documentation, the framework encourages organizations to treat regulatory excellence as a strategic differentiator, shifting the mindset from static compliance to continuous lifecycle oversight. Regulatory alignment thus becomes a living process that evolves with the product, data, and technology. Embedding this approach across teams will foster a culture of iterative improvement, innovation, and stronger organizational resilience. For many manufacturers, however, this will require introducing significant internal changes, from documentation practices to cross-functional collaboration. CEP 2.0 means faster timelines and higher predictability. But only if your team is ready. One of the most anticipated benefits of CEP 2.0 is more predictable review timelines and consistent submissions. However, leveraging these advantages depends heavily on industry readiness. Regulatory teams must adapt to more streamlined, data-driven processes and ensure that digital tools, training, and workflows support accelerated operations. Organizations that modernize will see multiple operational benefits early, including faster project completion, reduced rework, and quicker access to key markets as standardized documentation and cohesive global expectations will make previously complex or "slow” markets more accessible. For companies pursuing international expansion, CEP 2.0 provides a clearer path to global approvals, cross-market consistency, and enhanced competitiveness. Balancing challenges with opportunity. Despite its promise, the transition to CEP 2.0 is not without challenges. Data privacy, operational costs, supply chain complexity, and pressure on low-margin APIs remain key industry concerns that require striking a balance between stringent compliance and long-term sustainability. Still, companies that efficiently integrate regulatory requirements into scalable operations will not only demonstrate the maturity of their quality systems but also build trust externally, strengthening their reputation and differentiating their business in an increasingly competitive market. Looking ahead to a more collaborative future. CEP 2.0 positions the pharmaceutical sector for a future where regulatory excellence drives global competitiveness. Transparency, harmonization, and a lifecycle approach will increasingly define market leaders. The framework’s success, however, requires ongoing dialogue with regulators. Clear, practical guidance from the EDQM, combined with active feedback from manufacturers, is essential. The more open the collaboration, the more effectively CEP 2.0 will support innovation, quality, and patient safety. The question for every organization is how to approach this moment: as a compliance burden, or as a strategic opportunity to elevate quality, accelerate growth, and build long-term trust. Connect with Polpharma API: Your Partner in Pharma AdvancementFor more information on how Polpharma API can be your strategic ally in drug substance development and manufacturing, contact us at api@polpharma.comLet's embark on a journey of innovation and excellence together.

    Impressions: 273

    subscribeSubscribe

    https://www.pharmacompass.com/speak-pharma/expert-take-on-cep-2-0-a-new-era-of-transparency-in-pharmaceutical-regulation

    PharmaCompass
    13 Feb 2026
    Share info Share

    VLOG #PharmaReel

    [Sponsored by another company]

    ReelPharmaExpertise in Particle Size EngineeringExpertise in Particle Size Engineering

    Expertise in Particle Size Engineering
    Expertise in Particle Size Engineering

    reelExpertise in Particle Size Engineering

    This PharmaReel highlights Munit SA, a leading player with over 60 years of expertise in Micronization, Milling, and HPAPI Handling. By enhancing solubility and bioavailability, Munit SA delivers innovative pharmaceutical solutions that meet the highest industry standards. Certified by the FDA, PMDA, MHRA, MFDS, and other global authorities, Munit SA ensures excellence and compliance in every micronization process.

    Impressions: 180

    read-more

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

    This week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs (OPOE) without an approved generic. The OPOE list gets updated every six months.This list highlights drug products that have lost patent protection and regulatory exclusivity, but remain without approved generic competition in the US market. With this list, the FDA hopes to bolster competitiveness in the generics market, improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.Since December 2021, FDA has been publishing two versions of the OPOE list — one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).  Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 296 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The increase in drug products from 765 to 784 from June 2025 to December 2025 was due to the inclusion of additional dosage strengths in the OPOE Rx list. Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation), pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of ANDAs that aims to encourage and reward investment in drug manufacturing, research and development and strengthen the pharmaceutical supply chain in the United States.Separately, FDA has also come out with a new draft guidance that seeks to simplify biosimilarity studies and reduce unnecessary clinical testing. Through a separate initiative, the agency also plans to make it easier for biosimilars to be developed as interchangeable with brand-name biologics, thereby helping patients and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of 5.04 percent from 2025 to 2034. With several diabetes, immunology, oncology and cardiology drugs slated to face patent expirations this year, and continued pressure on drugmakers to improve affordability, we believe the generic market could grow at an even faster rate in the near term.
    subscribeSubscribe
    ExcelExcel Download

    Impressions: 1808

    https://www.pharmacompass.com/radio-compass-blog/fda-s-december-2025-opoe-list-features-784-prescription-drugs-73-otc-drugs

    #PharmaFlow by PHARMACOMPASS
    22 Jan 2026
    Share Share
    Contact Jin Dun Medical and get a quotation

    Jin Dun Medical is a supplier offers 109 products (APIs, Excipients or Intermediates).

    Find a price of Abaloparatide bulk offered by Jin Dun Medical

    Find a price of Abarelix bulk offered by Jin Dun Medical

    Find a price of Afamelanotide bulk offered by Jin Dun Medical

    Find a price of Agomelatine bulk offered by Jin Dun Medical

    Find a price of Alarelin Acetate bulk offered by Jin Dun Medical

    Find a price of Allopurinol bulk offered by Jin Dun Medical

    Find a price of Amoxicillin Trihydrate bulk offered by Jin Dun Medical

    Find a price of Antide bulk offered by Jin Dun Medical

    Find a price of Arginine Vasopressin bulk offered by Jin Dun Medical

    Find a price of Argireline bulk offered by Jin Dun Medical

    Find a price of Aspirin bulk offered by Jin Dun Medical

    Find a price of Atorvastatin bulk offered by Jin Dun Medical

    Find a price of Atosiban bulk offered by Jin Dun Medical

    Find a price of Betamethasone bulk offered by Jin Dun Medical

    Find a price of Bexarotene bulk offered by Jin Dun Medical

    Find a price of Bivalirudin bulk offered by Jin Dun Medical

    Find a price of Blonanserin bulk offered by Jin Dun Medical

    Find a price of Buserelin Acetate bulk offered by Jin Dun Medical

    Find a price of Calcitonin bulk offered by Jin Dun Medical

    Find a price of Capecitabine bulk offered by Jin Dun Medical

    Find a price of Carbetocin Acetate bulk offered by Jin Dun Medical

    Find a price of Cetrorelix Acetate bulk offered by Jin Dun Medical

    Find a price of Cisatracurium Besylate bulk offered by Jin Dun Medical

    Find a price of Clopidogrel bulk offered by Jin Dun Medical

    Find a price of Clozapine bulk offered by Jin Dun Medical

    Find a price of Colchicine bulk offered by Jin Dun Medical

    Find a price of Dapoxetine Hydrochloride bulk offered by Jin Dun Medical

    Find a price of Degarelix Acetate bulk offered by Jin Dun Medical

    Find a price of Desmopressin Acetate bulk offered by Jin Dun Medical

    Find a price of Dexamethasone bulk offered by Jin Dun Medical

    Find a price of Diclofenac Sodium bulk offered by Jin Dun Medical

    Find a price of Dihexa bulk offered by Jin Dun Medical

    Find a price of Dimefline bulk offered by Jin Dun Medical

    Find a price of Docetaxel bulk offered by Jin Dun Medical

    Find a price of Dronedarone Hydrochloride bulk offered by Jin Dun Medical

    Find a price of Duloxetine Hydrochloride bulk offered by Jin Dun Medical

    Find a price of Ectoine bulk offered by Jin Dun Medical

    Find a price of Eldecalcitol bulk offered by Jin Dun Medical

    Find a price of Empagliflozin bulk offered by Jin Dun Medical

    Find a price of Enalapril Maleate bulk offered by Jin Dun Medical

    Find a price of Epitalon bulk offered by Jin Dun Medical

    Find a price of Eptifibatide bulk offered by Jin Dun Medical

    Find a price of Erlotinib bulk offered by Jin Dun Medical

    Find a price of Exatecan bulk offered by Jin Dun Medical

    Find a price of Fludarabine Phosphate bulk offered by Jin Dun Medical

    Find a price of Gabapentin bulk offered by Jin Dun Medical

    Find a price of Ganirelix bulk offered by Jin Dun Medical

    Find a price of Gemcitabine bulk offered by Jin Dun Medical

    Find a price of Glucagon bulk offered by Jin Dun Medical

    Find a price of Glutathione bulk offered by Jin Dun Medical

    Find a price of Gonadorelin bulk offered by Jin Dun Medical

    Find a price of Goserelin Acetate bulk offered by Jin Dun Medical

    Find a price of Histrelin bulk offered by Jin Dun Medical

    Find a price of Hydrocortisone bulk offered by Jin Dun Medical

    Find a price of Imatinib Mesylate bulk offered by Jin Dun Medical

    Find a price of Irinotecan Hydrochloride bulk offered by Jin Dun Medical

    Find a price of L-Carnosine bulk offered by Jin Dun Medical

    Find a price of Lanreotide Acetate bulk offered by Jin Dun Medical

    Find a price of Lapatinib Ditosylate bulk offered by Jin Dun Medical

    Find a price of Letrozole bulk offered by Jin Dun Medical

    Find a price of Leuprolide Acetate bulk offered by Jin Dun Medical

    Find a price of Levetiracetam bulk offered by Jin Dun Medical

    Find a price of Levofloxacin bulk offered by Jin Dun Medical

    Find a price of Linaclotide bulk offered by Jin Dun Medical

    Find a price of Linagliptin bulk offered by Jin Dun Medical

    Find a price of Lixisenatide bulk offered by Jin Dun Medical

    Find a price of Lurasidone Hydrochloride bulk offered by Jin Dun Medical

    Find a price of Lypressin bulk offered by Jin Dun Medical

    Find a price of Mesna bulk offered by Jin Dun Medical

    Find a price of Montelukast Sodium bulk offered by Jin Dun Medical

    Find a price of Moxonidine bulk offered by Jin Dun Medical

    Find a price of Natriuretic Peptide, Brain bulk offered by Jin Dun Medical

    Find a price of Nifedipine bulk offered by Jin Dun Medical

    Find a price of Nilotinib bulk offered by Jin Dun Medical

    Find a price of Octreotide Acetate bulk offered by Jin Dun Medical

    Find a price of Olanzapine bulk offered by Jin Dun Medical

    Find a price of Paclitaxel bulk offered by Jin Dun Medical

    Find a price of Pasireotide bulk offered by Jin Dun Medical

    Find a price of Pemetrexed bulk offered by Jin Dun Medical

    Find a price of Peptavlon bulk offered by Jin Dun Medical

    Find a price of Plecanatide bulk offered by Jin Dun Medical

    Find a price of Prasugrel bulk offered by Jin Dun Medical

    Find a price of Pregabalin bulk offered by Jin Dun Medical

    Find a price of Rapastinel bulk offered by Jin Dun Medical

    Find a price of Remdesivir bulk offered by Jin Dun Medical

    Find a price of Rivaroxaban bulk offered by Jin Dun Medical

    Find a price of Rivastigmine Tartrate bulk offered by Jin Dun Medical

    Find a price of Rosuvastatin Calcium bulk offered by Jin Dun Medical

    Find a price of Semaglutide bulk offered by Jin Dun Medical

    Find a price of Sermorelin Acetate bulk offered by Jin Dun Medical

    Find a price of Sitagliptin Phosphate bulk offered by Jin Dun Medical

    Find a price of Somatostatin bulk offered by Jin Dun Medical

    Find a price of Sorafenib bulk offered by Jin Dun Medical

    Find a price of Sunitinib bulk offered by Jin Dun Medical

    Find a price of Taltirelin bulk offered by Jin Dun Medical

    Find a price of Teduglutide bulk offered by Jin Dun Medical

    Find a price of Tetracosactide bulk offered by Jin Dun Medical

    Find a price of Thymalfasin bulk offered by Jin Dun Medical

    Find a price of Thymine bulk offered by Jin Dun Medical

    Find a price of Thymopentin bulk offered by Jin Dun Medical

    Find a price of Thymulin bulk offered by Jin Dun Medical

    Find a price of Thyrotropin-Releasing Hormone bulk offered by Jin Dun Medical

    Find a price of Trelagliptin Succinate bulk offered by Jin Dun Medical

    Find a price of Triptorelin Pamoate bulk offered by Jin Dun Medical

    Find a price of Valacyclovir bulk offered by Jin Dun Medical

    Find a price of Valsartan bulk offered by Jin Dun Medical

    Find a price of Vapreotide bulk offered by Jin Dun Medical

    Find a price of Vilazodone bulk offered by Jin Dun Medical

    Find a price of Ziconotide bulk offered by Jin Dun Medical

    • Privacy policy
    • Terms and conditions
    • Disclaimers
    • LinkedIn
    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.