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    Essential Role of Intellectual Property in Pharmaceutical API Company

    15 Nov 2024

    // PRESS RELEASE

    Neul& Laboratories Q2 FY25 consolidated PAT falls to Rs. 32.84 Cr

    08 Nov 2024

    // INDPHARMAPOST

    Achieving Drug Development Success: Neuland’s Three-Pillar Strategy

    03 Oct 2024

    // PRESS RELEASE

    DATA COMPILATION
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    About

    Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the pharmaceutical industry’s chemistry requirements, from the synthesis of library compounds to supplying NCEs and advanced intermediates at various stages in the clinical life cycle, as well as commercial launch. Neuland’s expertise is in the manufacturing of APIs and advanced intermediates from its USFDA-approved facilities. Its core competency lies in the application of powerful process chemistry to manufacturing in a regulatory-compliant environment.

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    India
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    11th Floor (5th Level), Phoenix IVY Building, Plot No. 573A-III, Road No. 82, ...
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    +91 9849431936, +91 40 67611600 / 700
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    marketing@neulandlabs.com
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    CPhI India 2024

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    Product List 2024

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    Products Under Development 2024

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    Small Molecule Custom Development & Manufacturing 2024

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    List of Fmoc Building Blocks 2024

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    GMP Certificate 2023

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik. View CDMO Activity Tracker for H1 2024 (Free Excel Available)Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs. View CDMO Activity Tracker for H1 2024 (Free Excel Available) EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal. View CDMO Activity Tracker for H1 2024 (Free Excel Available) Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    #PharmaFlow by PHARMACOMPASS
    08 Aug 2024
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    Essential Role of Intellectual Property in Pharmaceutical API Company
    Essential Role of Intellectual Property in Pharmaceutical API Company

    15 Nov 2024

    // PRESS RELEASE

    https://www.neulandlabs.com/en/insights/stories/essential-role-intellectual-property-expertise-pharmaceutical-api-company

    PRESS RELEASE
    15 Nov 2024
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    Neul& Laboratories Q2 FY25 consolidated PAT falls to Rs. 32.84 Cr
    Neul& Laboratories Q2 FY25 consolidated PAT falls to Rs. 32.84 Cr

    08 Nov 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/neuland-laboratories-q2-fy25-consolidated-pat-falls-to-rs-3284-cr-16410

    INDPHARMAPOST
    08 Nov 2024
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    Achieving Drug Development Success: Neuland’s Three-Pillar Strategy
    Achieving Drug Development Success: Neuland’s Three-Pillar Strategy

    03 Oct 2024

    // PRESS RELEASE

    https://www.neulandlabs.com/en/insights/stories/achieving-drug-development-success-inside-neulands-three-pillar-project-management

    PRESS RELEASE
    03 Oct 2024
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    Inside Neuland’s Three-Pillar Project Management Strategy
    Inside Neuland’s Three-Pillar Project Management Strategy

    03 Oct 2024

    // PRESS RELEASE

    https://www.neulandlabs.com/en/insights/stories/achieving-drug-development-success-inside-neulands-three-pillar-project-management

    PRESS RELEASE
    03 Oct 2024
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    Securing Sustainability in Pharma Supply Chain – Sucheth Davuluri
    Securing Sustainability in Pharma Supply Chain – Sucheth Davuluri

    01 Oct 2024

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    https://www.neulandlabs.com/sites/neulandlabs/files/neuland-labs/insights/news/SUCHETH_DAVULURI_Article.pdf

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    01 Oct 2024
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    Defining New Rules – The Evolution of the CDMO Industry – Saharsh
    Defining New Rules – The Evolution of the CDMO Industry – Saharsh

    02 Sep 2024

    // PRESS RELEASE

    https://www.neulandlabs.com/sites/neulandlabs/files/neuland-labs/insights/news/Saharsh_Article_The_Evolution_of_the_CDMO_Industry.pdf

    PRESS RELEASE
    02 Sep 2024
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    ALL APIs

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    01

    Ciprofloxacin

    India

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    Booth #4.G20
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-04-02

    Pay. Date : 2013-09-27

    DMF Number : 18465

    Submission : 2005-06-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-389 - Rev 03

    Issue Date : 2023-11-28

    Type : Chemical

    Substance Number : 1089

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10357

    Registrant's Address : 11th Floor (5th Office Level), Phoenix IVY Building, Plot No. 573A-Ⅲ, Road No. 82, Jubilee Hills,Hyderabad-33 Telangana, India

    Initial Date of Registration : 2007-12-13

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0127

    Start Marketing Date : 2017-11-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Enalapril Maleate

    India

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

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    Booth #4.G20
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15434

    Submission : 2001-05-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-078 - Rev 14

    Issue Date : 2023-06-07

    Type : Chemical

    Substance Number : 1420

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10252

    Registrant's Address : 11th Floor (5th Office Level), Phoenix IVY Building, Plot No. 573A-Ⅲ, Road No. 82, Jubilee Hills,Hyderabad-33 Telangana, India

    Initial Date of Registration : 2007-07-26

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0125

    Start Marketing Date : 2017-11-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2018-10-14

    Registration Number : 20050831-12-B-44-02(1)

    Manufacturer Name : Neuland Lab. Ltd

    Manufacturer Address : Sy.No: 347,473,474,490/2 Bonthapalli (V), Veerabhadraswamy temple road, Jinnaram (M), Medak (Dist.)-502 313 Telangana, India

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    03

    Levetiracetam

    India

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

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    Booth #4.G20
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-05-04

    Pay. Date : 2014-07-24

    DMF Number : 17799

    Submission : 2004-11-02

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2011-380 - Rev 07

    Issue Date : 2024-08-02

    Type : Chemical

    Substance Number : 2535

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 302MF10084

    Registrant's Address : 11th Floor (5th Office Level), Phoenix IVV Building, Plot No. 573A-III, Road No. 82, Jubilee Hills,Hyderabad-33 Telangana, India

    Initial Date of Registration : 2020-07-16

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 58032-0132

    Start Marketing Date : 2020-03-06

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Korea Pfizer Pharmaceutical Co., Ltd.

    Registration Date : 2016-06-10

    Registration Number : 20160610-183-I-484-26

    Manufacturer Name : Neuland Laboratories Limited (Unit-Ⅰ)

    Manufacturer Address : Sy. No. 347, 473, 474, 490/2, Bonthapalli Village, Veerabhadra swamy Temple Road, Jinnaram Mandal, Medak District - 502 313, Telangana State, India

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    04

    Mirtazapine

    India

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    Booth #4.G20
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16007

    Submission : 2002-06-11

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2008-243 - Rev 05

    Issue Date : 2022-12-19

    Type : Chemical

    Substance Number : 2338

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 301MF10005

    Registrant's Address : 11th Floor (5th Office Level), Phoenix IVY Building, Plot No. 573A-Ⅲ, Road No. 82, Jubilee Hills,Hyderabad-33 Telangana, India

    Initial Date of Registration : 2019-05-15

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0121

    Start Marketing Date : 2017-12-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Medipoem Co., Ltd.

    Registration Date : 2024-01-12

    Registration Number : 20201022-209-J-571(3)

    Manufacturer Name : Neuland Laboratories Limited

    Manufacturer Address : Unit-I, Sy. No. 347,473,474, 490/2, Bonthapally Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District-502 313, Telangana State, India

     VMF Others AUDIT
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    05

    Ciprofloxacin Hydrochloride

    India

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

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    CPhI India 2024
    Booth #4.G20
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-10-26

    Pay. Date : 2012-12-13

    DMF Number : 13250

    Submission : 1998-09-29

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-405 - Rev 13

    Issue Date : 2024-10-16

    Type : Chemical

    Substance Number : 888

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0037

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0006

    Start Marketing Date : 2017-12-14

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Sungwoo Chemical Co., Ltd.

    Registration Date : 2019-01-31

    Registration Number : 20080507-85-D-53-09(1)

    Manufacturer Name : Neuland Laboratories Ltd

    Manufacturer Address : Plot No.s 92,93,94,257,258,259 IDA, Pashamylaram, Isnapur, Patancheru(M), Medak Dist. -502 319, Andhra Pradesh, India

     VMF Others AUDIT
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    06

    Ipratropium Bromide

    India

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

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    CPhI India 2024
    Booth #4.G20
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-01-15

    Pay. Date : 2014-01-03

    DMF Number : 15130

    Submission : 2000-11-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2012-126 - Rev 02

    Issue Date : 2023-04-14

    Type : Chemical

    Substance Number : 919

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0100

    Start Marketing Date : 2015-04-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2020-07-02

    Registration Number : 20130614-188-I-356-02(A)

    Manufacturer Name : Neuland Laboratories Ltd.

    Manufacturer Address : Unit-I, Sy. No: 347, 473, 474, 490/2, Bonthapally Village, Veerabhadraswamy Temple Road, Gummadidala Mandal, Sangareddy District - 502 313, Telangana State, India

     VMF Others AUDIT
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    07

    Itraconazole

    India

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

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    CPhI India 2024
    Booth #4.G20
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-02-12

    Pay. Date : 2013-06-19

    DMF Number : 15445

    Submission : 2001-05-15

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-220 - Rev 06

    Issue Date : 2021-09-07

    Type : Chemical

    Substance Number : 1335

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0110

    Start Marketing Date : 2017-11-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Neuland

    Product
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    Market
    Place

    08

    Ofloxacin

    India

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

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    CPhI India 2024
    Booth #4.G20
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-10-26

    Pay. Date : 2015-10-15

    DMF Number : 15433

    Submission : 2001-05-15

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 218MF10618

    Registrant's Address : 204, ⅠⅠ Floor, Meridian Plaza, 6-3-853/1, Ameerpet, Hyderabad-500016, Andhra Pradesh, India

    Initial Date of Registration : 2006-07-03

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0090

    Start Marketing Date : 2017-12-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Neuland

    Product
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    Place

    09

    Ramipril

    India

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

    arrow
    CPhI India 2024
    Booth #4.G20
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16647

    Submission : 2003-06-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-219 - Rev 07

    Issue Date : 2022-12-16

    Type : Chemical

    Substance Number : 1368

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0123

    Start Marketing Date : 2017-12-13

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Salbutamol Sulphate

    India

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

    arrow
    CPhI India 2024
    Booth #4.G20
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16104

    Submission : 2002-08-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2000-143 - Rev 07

    Issue Date : 2022-03-15

    Type : Chemical

    Substance Number : 687

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-0002

    Start Marketing Date : 2017-11-27

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2021-05-11

    Registration Number : 20210511-209-J-985

    Manufacturer Name : Neuland Laboratories Limited

    Manufacturer Address : Unit 1, Sy. No. 347, 473, 474, 490/2, Bonthapalli Village, Veerabhadraswamy Temple road, Gummadidala Mandal, Sangareddy District 502313, Telangana State, India

     VMF ASMF arrow-down
    ✖
    Available Reg. Filing : ASMF
    AUDIT
    Neuland

    Product
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    USDMF

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    01

    Albuterol Sulfate Usp

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-09-26

    Pay. Date : 2013-08-29

    DMF Number : 16371

    Submission : 2003-01-20

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    02

    Albuterol Usp

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16104

    Submission : 2002-08-16

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    03

    Alcaftadine

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-01-05

    Pay. Date : 2014-11-24

    DMF Number : 28277

    Submission : 2014-05-08

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    04

    Apixaban

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2018-07-16

    Pay. Date : 2018-06-13

    DMF Number : 32422

    Submission : 2018-01-31

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    05

    Apixaban (process-ii)

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 39444

    Submission : 2024-01-31

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    06

    Apremilast

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32953

    Submission : 2018-11-06

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    07

    Aripiprazole Lauroxil

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32683

    Submission : 2018-03-31

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    08

    Aripiprazole Monohydrate (sterile)

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-09-26

    Pay. Date : 2023-08-28

    DMF Number : 36451

    Submission : 2021-11-06

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    09

    Aripiprazole Usp (anhydrous Form - B...

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2021-11-18

    Pay. Date : 2021-08-10

    DMF Number : 22889

    Submission : 2009-06-24

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

    Market
    Place

    10

    Bosentan Monohydrate

    India
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Neuland Laboratories

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-10-13

    Pay. Date : 2015-07-09

    DMF Number : 26038

    Submission : 2012-05-09

    Status : Active

    Type : II

    Neuland

    Product
    Web Link

    Stock Recap
    #PipelineProspector

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    KEY PRODUCTS

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    Services

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    Analytical

    Discover their expertise for : Analytical

    API Manufacturing

    Discover their expertise for : API Manufacturing

    Protein / Peptide

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    01

    PEPTIDE SYNTHESIS SERVICES

    India
    Contact Supplier
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    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Pharma Service : API Manufacturing

    Neuland Laboratories

    Neuland’s peptide synthesis services include the production of peptides from mg to multi-kg scale by standard sequential chemical peptide and segment condensation strategies. It offers SPPS, LPPS, and hybrid technologies for peptide synthesis.

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    Category : Protein / Peptide

    Sub Category : Synthesis

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Pharma Service : API Manufacturing

    PEPTIDE SYNTHESIS SERVICES

    Neuland’s peptide synthesis services include the production of peptides from mg to multi-kg scale by standard sequential chemical peptide and segment condensation strategies. It offers SPPS, LPPS, and hybrid technologies for peptide synthesis.

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    Peptide Synthesis Services

    Service
    Web Link

    Capabilities
    #ServicesBio

    Market
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    02

    PEPTIDE API MANUFACTURING SERVIC...

    India
    Contact Supplier
    arrow
    BOS Manchester
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Pharma Service : API Manufacturing

    Neuland Laboratories

    Neuland is a contract development and manufacturing organization (CDMO) that offers peptide API manufacturing. Its custom manufacturing solutions for peptides include process development & optimization, clinical supply, and large scale cGMP manufacturing.

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    Category : Protein / Peptide

    Sub Category : Overview

    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

    Pharma Service : API Manufacturing

    PEPTIDE API MANUFACTURING SERVICES

    Neuland is a contract development and manufacturing organization (CDMO) that offers peptide API manufacturing. Its custom manufacturing solutions for peptides include process development & optimization, clinical supply, and large scale cGMP manufacturing.

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    Peptide API Manufacturing Services

    Service
    Web Link

    Capabilities
    #ServicesBio

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    API & Drug Product Development

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    Inspections and registrations

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    ABOUT THIS PAGE

    Contact Neuland Laboratories and get a quotation

    Neuland Laboratories is a supplier offers 99 products (APIs, Excipients or Intermediates).

    Find a price of Ciprofloxacin bulk with DMF, CEP, JDMF, WC offered by Neuland Laboratories

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