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    Company profile for Coral Drugs Private Limited

    Coral Drugs Private Limited-PSE
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    What a World-Class API Manufacturing Facility Looks Like

    28 Jan 2026

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    Precision Nano-Sizing: Shaping the Future of Advanced APIs

    21 Jan 2026

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    Precision at the Micron Level for Reliable APIs

    14 Jan 2026

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    DATA COMPILATION
    #PharmaFlow

    Corel Drugs cGMP partner for APIs

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    Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.

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    About

    Coral Drugs is a research-based international pharmaceutical company with over 27 years of expertise in manufacturing high-quality, affordable APIs. Headquartered in Delhi, India, it produces APIs for antineoplastics, steroids, non-steroids, hormones, and beta-agonists. Coral Drugs also offers custom research and manufacturing services through its cGMP-approved facilities in north India, equipped for R&D, pilot, and commercial-scale production. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.

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    Coral Drugs Private Limitedindia-flag Flag
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    India
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    1001, Akash Deep Building 26-A, Barakhamba Road New Delhi – 110001
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    +91 1244518100
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    sales@coraldrugs.com
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    https://coraldrugs.com/
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    https://www.linkedin.com/company/coral-drugs-pvt-ltd-/
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    CPhI China

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    VLOG #PharmaReel

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    ReelPharmaPartner in End-to-End API ManufacturingPartner in End-to-End API Manufacturing

    Partner in End-to-End API Manufacturing
    Partner in End-to-End API Manufacturing

    reelPartner in End-to-End API Manufacturing

    This PharmaReel showcases Coral Drugs, a global partner in end-to-end API manufacturing with more than 27 years of expertise. Supported by vertically integrated cGMP and ISO-compliant facilities, the company is backed by USFDA and EMA certifications, patents, and advanced micronization capabilities.

    Impressions: 3966

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2026

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    Corporate Presentation

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    GMP Certificate 2025

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    DATA COMPILATION #PharmaFlow

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    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    CEP Q1 2026 Update: CEP 2.0, EDQM’s new guidelines strengthen ecosystem; Indian firms top list of CEPs issued

    PharmaCompass is introducing a new regulatory update that tracks developments in Certificates of Suitability to the Monographs of the European Pharmacopoeia, referred to as CEPs. These certificates are a critical regulatory instrument in the global pharmaceutical supply chain.Also known as a Certification of Suitability (COS), CEPs are issued by the European Directorate for the Quality of Medicines and HealthCare (EDQM), with or without inspection of the manufacturing site. A CEP must be renewed every five years from its original issue date to remain valid, regardless of any revisions made during the interim period. However, a CEP does not replace Good Manufacturing Practice certification.CEPs are recognized as a trusted reference for API quality, thereby simplifying global registration strategies. Apart from Europe, the CEP system is widely used by many regulatory authorities, including those in Canada, Australia, Brazil, Singapore and South Africa. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)CEP 2.0 enhances regulatory clarity, brings efficiency, global interoperability There are several types of CEPs, depending on the nature of the substance and evaluation. The most common type is the Chemical CEP, which confirms that a chemically synthesized API meets standards for purity and impurity control. Then there are Herbal CEPs for herbal substances and preparations.Another key category is the TSE CEP, which addresses risks associated with transmissible spongiform encephalopathies in animal-derived materials. In addition, there are Combined CEPs that may cover multiple aspects, such as chemical quality, TSE risk, and sterility. However, biological products such as vaccines and blood products fall outside the scope of the CEP framework.In 2023, the CEP system underwent a major transformation with the introduction of CEP 2.0, which marks a shift from a largely document-based system to a more structured, transparent, and digitally aligned model. This makes it easier for companies to manage compliance while improving trust among global regulators.While increasing data and compliance requirements for API manufacturers, CEP 2.0 enables better regulatory clarity, streamlined dossier integration, and stronger global acceptance. Overall, CEP 2.0 is designed to enhance regulatory clarity while making the system more efficient and globally interoperable. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Indian firms issued maximum CEPs; Sun Pharma and its subsidiaries, Jubilant Biosys top listIndia topped the charts for CEPs issued, both in terms of new CEPs and revisions in the first quarter (Q1) of 2026. Indian companies were issued 81 new CEPs in Q1 2026 (as against 40 in Q1 2025) and 203 revisions (as against 129 in Q1 2025). In comparison, Chinese companies were issued 42 new CEPs in Q1 2026 (against 25 in Q1 2025) and 53 revisions (against 67 in Q1 2025). Italy came a distant third, followed by Germany and Spain.India’s Sun Pharmaceuticals and its subsidiaries topped the list of companies with the maximum number of CEPs issued— while no new CEP was issued, 27 CEPs were revised in Q1 2026. At second place was Jubilant Biosys — 21 CEPs were revised in Q1 2026.In terms of products, the maximum CEPs were issued for amlodipine besylate (a calcium channel blocker used for treating hypertension), followed by sitagliptin phosphate (a type 2 diabetes medicine) and pregabalin (a drug used to treat neuropathic pain, fibromyalgia, seizures, and generalized anxiety disorder). Both amlodipine besylate and sitagliptin phosphate had not been issued new CEPs or revisions in Q1 2025. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)EDQM introduces new guidelines to accelerate CEP assessments The EDQM charges fees for various services related to CEPs that depend on the type of request or regulatory activity involved. In general, fees apply to handling CEP applications, revisions or renewals and for offering technical advice (where applicants seek scientific or regulatory guidance).In March 2026, the EDQM introduced two new guidelines aimed at accelerating CEP assessments. The first is a reliance-based assessment pathway, which allows regulators to leverage prior approvals from trusted authorities, such as those in the EU, UK, Australia, Canada, and the WHO pre-qualification program. The second is a fast-track assessment route designed to expedite reviews in situations such as medicine shortages and to support initiatives like the EU Critical Medicines Act.Timelines have been significantly compressed under these new pathways. Initial evaluations are completed within 46 working days, compared to up to 115 days under the standard procedure. Applicants are given 30 calendar days to respond to queries, after which regulators complete the final assessment within 23 working days.Another important regulatory update relates to electronic submissions. From April 1, 2026, the EDQM will reject non-compliant CEP applications at the point of submission. All applications must include a validated electronic Common Technical Document (eCTD) dossier along with a proper validation report, submitted in line with the updated Common European Submission Portal (CESP) guidelines. Taken together, these developments signal a more rigorous yet efficient CEP ecosystem. View CEPs Issued in Q1 2026 (Power BI Dashboard, Free Excel Available)Our viewThe shift to CEP 2.0 signals a move toward greater transparency, digitalization, and global regulatory alignment. Though enhanced disclosure and stricter e-submission requirements may increase the compliance burden, especially for smaller manufacturers, the long-term gains are expected to be significant. Going forward, companies that invest in data quality and regulatory readiness stand to gain from these changes.
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    https://www.pharmacompass.com/radio-compass-blog/cep-q1-2026-update-cep-2-0-edqm-s-new-guidelines-strengthen-ecosystem-indian-firms-top-list-of-ceps-issued

    #PharmaFlow by PHARMACOMPASS
    09 Apr 2026
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    NEWS #PharmaBuzz

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    What a World-Class API Manufacturing Facility Looks Like
    What a World-Class API Manufacturing Facility Looks Like

    28 Jan 2026

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    https://www.coraldrugs.com/news/what-a-world-class-api-manufacturing-facility-looks-like

    PRESS RELEASE
    28 Jan 2026
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    Precision Nano-Sizing: Shaping the Future of Advanced APIs
    Precision Nano-Sizing: Shaping the Future of Advanced APIs

    21 Jan 2026

    // PRESS RELEASE

    https://www.coraldrugs.com/news/precision-nano-sizing-shaping-the-future-of-advanced-apis

    PRESS RELEASE
    21 Jan 2026
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    Precision at the Micron Level for Reliable APIs
    Precision at the Micron Level for Reliable APIs

    14 Jan 2026

    // PRESS RELEASE

    https://www.coraldrugs.com/news/precision-at-the-micron-level-for-reliable-apis

    PRESS RELEASE
    14 Jan 2026
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    India's ₹60000+ Cr API Push & Its Impact on Pharma
    India's ₹60000+ Cr API Push & Its Impact on Pharma

    07 Jan 2026

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    https://www.coraldrugs.com/news/indias-60-000-crore-api-push-and-its-impact-on-pharmaceutical-manufacturing

    PRESS RELEASE
    07 Jan 2026
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    Where Quality Meets Innovation in API Manufacturing
    Where Quality Meets Innovation in API Manufacturing

    08 Oct 2025

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    https://www.coraldrugs.com/news/coral-drugs-where-quality-meets-innovation-in-api-manufacturing

    PRESS RELEASE
    08 Oct 2025
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    US FDA Inspection Successfully Concluded at Coral Drugs’ Facility
    US FDA Inspection Successfully Concluded at Coral Drugs’ Facility

    26 Aug 2025

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    https://www.coraldrugs.com/news/us-fda-inspection-successfully-concluded-at-coral-drugs-facility

    PRESS RELEASE
    26 Aug 2025
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    KEY PRODUCTS

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    Services

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    API Manufacturing

    Discover their expertise for : API Manufacturing

    API & Drug Product Development

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    Coral Drugs

    ABOUT THIS PAGE

    Contact Coral Drugs Private Limited and get a quotation

    Coral Drugs Private Limited is a supplier offers 44 products (APIs, Excipients or Intermediates).

    Find a price of Azelastine Hydrochloride bulk with DMF, CEP, WC offered by Coral Drugs Private Limited

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    Find a price of Flutamide bulk with CEP, WC offered by Coral Drugs Private Limited

    Find a price of Triamcinolone bulk with CEP, WC offered by Coral Drugs Private Limited

    Find a price of Mometasone Furoate bulk with DMF offered by Coral Drugs Private Limited

    Find a price of Clobetasol Propionate bulk with WC offered by Coral Drugs Private Limited

    Find a price of Danazol bulk with WC offered by Coral Drugs Private Limited

    Find a price of Fluocinolone Acetonide bulk with WC offered by Coral Drugs Private Limited

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    Find a price of Isoflupredone Acetate bulk with WC offered by Coral Drugs Private Limited

    Find a price of Salmeterol Xinafoate bulk with WC offered by Coral Drugs Private Limited

    Find a price of Azelastine Hydrochloride bulk offered by Coral Drugs Private Limited

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    Find a price of Ciclesonide bulk offered by Coral Drugs Private Limited

    Find a price of Clobetasol Propionate bulk offered by Coral Drugs Private Limited

    Find a price of Danazol bulk offered by Coral Drugs Private Limited

    Find a price of Exemestane bulk offered by Coral Drugs Private Limited

    Find a price of Flutamide bulk offered by Coral Drugs Private Limited

    Find a price of Formoterol Fumarate bulk offered by Coral Drugs Private Limited

    Find a price of Isoflupredone Acetate bulk offered by Coral Drugs Private Limited

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    Find a price of Medroxyprogesterone Acetate bulk offered by Coral Drugs Private Limited

    Find a price of Megestrol Acetate bulk offered by Coral Drugs Private Limited

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