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    Company profile for Lifecare Laboratories Pvt Ltd

    Lifecare Laboratories-PSE
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    Lifecare Labs manufactures bulk drugs (APIs) and intermediates in line with stringent quality standards. The company focuses on delivering cost-effective solutions while meeting customer requirements and building long-term partnerships. With state-of-the-art manufacturing facilities and dedicated production units, Lifecare Labs emphasizes quality, operational excellence, and responsible business practices, serving pharmaceutical markets with a commitment to reliability and sustainability. 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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    Lifecare Laboratories Pvt Ltdindia-flag Flag
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    India
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    # 102, Doyen Chambers Behind Saradhi Studio, Ameerpet, Hyderabad - 500 073, Te...
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    +91 4023750123
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    varma@lifecarelabs.com
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    http://www.lifecarelabs.com/
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    Mail ID: akhil@lifecarelabs.com 

     

    USA :

    # 3945 Stonecliffe Drive Monroeville,

    PA-15146

    Ph :+1-412-251-4996

    anisha@lifecarelabs.com

    info@lifecarelabs.com

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    CEP 2023-093 / Cabergoline

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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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    ALL APIs

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    01

    Biperiden Hydrochloride

    India

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

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    • fda
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2018-226 - Rev 00

    Issue Date : 2021-10-26

    Type : Chemical

    Substance Number : 1074

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 305MF10051

    Registrant's Address : 78/A, Bengalrao Nagar, Hyderabad-500 038, Telangana State, India.

    Initial Date of Registration : 2023-04-25

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2023-06-01

    Valid Till : 2025-10-14

    Written Confirmation Number : WC-0456

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    02

    Cabergoline

    India

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

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    USDMF CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2023-093 - Rev 01

    Issue Date : 2026-04-30

    Type : Chemical

    Substance Number : 1773

    Status : Valid

     JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    03

    Dexmedetomidine Hydrochloride

    India

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

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    CPhI China
    Attending
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2026-05-13

    Valid Till : 2029-05-12

    Written Confirmation Number : WC-0548

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    04

    Bromocriptine Mesylate

    India

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

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    CPhI China
    Attending
    • fda
    • EDQM
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    Stock Recap
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    05

    Lysergol

    India

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

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    CPhI China
    Attending
    • fda
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    06

    Melperone

    India

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

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    CPhI China
    Attending
    • fda
    • EDQM
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    07

    Metaraminol Bitartrate

    India

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

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    CPhI China
    Attending
    • fda
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    08

    Nicergoline

    India

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

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    CPhI China
    Attending
    • fda
    • EDQM
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

    Product
    Web Link

    Stock Recap
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    09

    Parecoxib Sodium

    India

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

    arrow
    CPhI China
    Attending
    • fda
    • EDQM
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

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    Web Link

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    10

    Perampanel

    India

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

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    CPhI China
    Attending
    • fda
    • EDQM
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    Virtual BoothLifecare Labs has been developing innovative products in specialist areas of medicine.
    USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    LifeCare Laboratories

    Product
    Web Link

    Stock Recap
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    ABOUT THIS PAGE

    Contact Lifecare Labs and get a quotation

    Lifecare Labs is a supplier offers 27 products (APIs, Excipients or Intermediates).

    Find Biperiden Hydrochloride bulk with CEP, JDMF offered by Lifecare Labs

    Find Cabergoline bulk with CEP offered by Lifecare Labs

    Find Dexmedetomidine Hydrochloride bulk with WC offered by Lifecare Labs

    Find Ataluren bulk offered by Lifecare Labs

    Find Benserazide Hydrochloride bulk offered by Lifecare Labs

    Find Bromocriptine bulk offered by Lifecare Labs

    Find Bromocriptine Mesylate bulk offered by Lifecare Labs

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    Find Famciclovir bulk offered by Lifecare Labs

    Find Isocarboxazid bulk offered by Lifecare Labs

    Find Istradefylline bulk offered by Lifecare Labs

    Find L-Carnitine Tartrate bulk offered by Lifecare Labs

    Find L-Glutamine bulk offered by Lifecare Labs

    Find Lysergol bulk offered by Lifecare Labs

    Find Melperone bulk offered by Lifecare Labs

    Find Metaraminol Bitartrate bulk offered by Lifecare Labs

    Find Nicergoline bulk offered by Lifecare Labs

    Find Parecoxib Sodium bulk offered by Lifecare Labs

    Find Pentamidine Isethionate bulk offered by Lifecare Labs

    Find Perampanel bulk offered by Lifecare Labs

    Find Phenazopyridine bulk offered by Lifecare Labs

    Find Sitagliptin Phosphate bulk offered by Lifecare Labs

    Find Suplatast Tosilate bulk offered by Lifecare Labs

    Find Telmisartan bulk offered by Lifecare Labs

    Find Ticagrelor bulk offered by Lifecare Labs

    Find Tranexamic Acid bulk offered by Lifecare Labs

    Find Troxerutin bulk offered by Lifecare Labs

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