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    Company profile for Coral Drugs Private Limited

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

    28 Jan 2026

    // PRESS RELEASE

    Precision Nano-Sizing: Shaping the Future of Advanced APIs

    21 Jan 2026

    // PRESS RELEASE

    Precision at the Micron Level for Reliable APIs

    14 Jan 2026

    // PRESS RELEASE

    DATA COMPILATION
    #PharmaFlow

    Corel Drugs cGMP partner for APIs

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    Latest Content by PharmaCompass

    https://www.pharmacompass.com/video-pharmareel/coral-drugs-private-limited/your-end-to-end-api-partner

    EVENTS

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    ACTIVE PHARMA INGREDIENTS

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    Key Products KEY PRODUCTS

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    PharmaCompass

    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
    Address
    Address
    1001, Akash Deep Building 26-A, Barakhamba Road New Delhi – 110001
    Telephone
    Telephone
    +91 1244518100
    Client Email
    Email
    sales@coraldrugs.com
    Client Website
    Website
    https://coraldrugs.com/
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    https://www.linkedin.com/company/coral-drugs-pvt-ltd-/
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    VLOG #PharmaReel

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    ReelPharmaYour End-to-End API PartnerYour End-to-End API Partner

    Your End-to-End API Partner
    Your End-to-End API Partner

    reelYour End-to-End API Partner

    This PharmaReel spotlights Coral Drugs, your trusted partner in end-to-end API manufacturing. Specializing in high-quality APIs with a strong focus on steroids and hormones, Coral Drugs is a vertically integrated, cGMP-certified international company committed to delivering excellence at every stage of manufacturing, backed by quality, consistency, and reliability you can trust.

    Impressions: 2300

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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2026

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      https://www.pharmacompass.com/pdf/party/content/coral-drugs-private-limited-party-content-30992.pdf

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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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    Impressions: 2591

    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

    // PRESS RELEASE

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

    PRESS RELEASE
    28 Jan 2026
    Share Share
    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
    Share Share
    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

    // PRESS RELEASE

    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

    // PRESS RELEASE

    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

    // PRESS RELEASE

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

    PRESS RELEASE
    26 Aug 2025
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    ALL APIs

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    01

    Azelastine Hydrochloride

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2023-11-01

    Pay. Date : 2023-09-22

    DMF Number : 36205

    Submission : 2021-10-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-124 - Rev 00

    Issue Date : 2022-08-10

    Type : Chemical

    Substance Number : 1633

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49076-7601

    Start Marketing Date : 2019-06-17

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

    Product
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    Market
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    02

    Budesonide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30534

    Submission : 2017-02-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-020 - Rev 01

    Issue Date : 2026-01-06

    Type : Chemical

    Substance Number : 1075

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49076-6111

    Start Marketing Date : 2017-11-02

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

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    Web Link

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    Market
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    03

    Ciclesonide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38283

    Submission : 2023-04-08

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2022-270 - Rev 00

    Issue Date : 2024-10-31

    Type : Chemical

    Substance Number : 2703

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

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    Market
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    04

    Exemestane

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38247

    Submission : 2023-03-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-032 - Rev 00

    Issue Date : 2025-07-04

    Type : Chemical

    Substance Number : 2766

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

    Product
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    Stock Recap
    #PipelineProspector

    Market
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    05

    Fluticasone Furoate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32040

    Submission : 2017-10-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-018 - Rev 00

    Issue Date : 2023-03-06

    Type : Chemical

    Substance Number : 2768

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49076-6452

    Start Marketing Date : 2022-03-02

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Gunil Pharmaceutical Co., Ltd.

    Registration Date : 2025-02-14

    Registration Number : Su458-6-ND

    Manufacturer Name : Coral Drugs Private Limited

    Manufacturer Address : 55-56-57, HSIIDC Industrial Estate, Murthal, Sonepat, Haryana 131039, India

     VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

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    06

    Fluticasone Propionate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Booth #E1D25
    • fda
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    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-05-11

    Pay. Date : 2018-04-10

    DMF Number : 21879

    Submission : 2008-08-12

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2005-055 - Rev 03

    Issue Date : 2020-09-25

    Type : Chemical

    Substance Number : 1750

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49076-5501

    Start Marketing Date : 2018-10-26

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Formoterol Fumarate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30324

    Submission : 2016-06-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-105 - Rev 00

    Issue Date : 2022-09-28

    Type : Chemical

    Substance Number : 1724

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49076-7001

    Start Marketing Date : 2016-02-25

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Mometasone Furoate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 30852

    Submission : 2016-09-09

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-081 - Rev 00

    Issue Date : 2023-05-26

    Type : Chemical

    Substance Number : 1449

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49076-5701

    Start Marketing Date : 2025-10-18

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2025-01-14

    Registration Number : 20250114-211-J-1665

    Manufacturer Name : Coral Drugs Private Limited

    Manufacturer Address : 55-57, HSIIDC Industrial Estate, Murthal, District-Sonepat, Haryana India

     VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Mometasone Furoate

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31076

    Submission : 2016-11-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2024-282 - Rev 00

    Issue Date : 2024-10-17

    Type : Chemical

    Substance Number : 2858

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 49076-5702

    Start Marketing Date : 2025-10-17

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

    Product
    Web Link

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    Market
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    10

    Triamcinolone Hexacetonide

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI China
    Booth #E1D25
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCoral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 37346

    Submission : 2022-08-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2021-078 - Rev 00

    Issue Date : 2022-03-28

    Type : Chemical

    Substance Number : 867

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2025-11-20

    Valid Till : 2028-11-19

    Written Confirmation Number : WC-0009

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    Corel Drugs cGMP partner for APIs

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
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    Services

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    API Manufacturing

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    Coral Drugs

    ABOUT THIS PAGE

    Contact Coral Drugs Pvt. Ltd and get a quotation

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

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