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    Company profile for Cohance Lifesciences

    Cohance Lifesciences-PSE
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    Suven, Cohance to Double Business Revenue to Rs 6,000 Cr by FY29

    01 Nov 2024

    // ECONOMICTIMES

    Cohance Lifesciences merger with Suven Pharma gets NSE, BSE nod

    27 Jul 2024

    // TIMESOFINDIA

    Suven, with Cohance and more, wants to become a CDMO powerhouse

    02 Mar 2024

    // ECONOMIC TIMES

    DATA COMPILATION
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    Cohance Lifesciences

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    Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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    About

    Cohance Lifesciences is a leading CDMO and API platform, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our expertise in complex chemistries, we provide end-to-end CDMO services to global innovators and have delivered numerous projects from concept to commercialization over the years.As a global API player, we serve customers across nearly 60 countries with 80+ molecules backed by robust R&D, regulatory capabilities and manufacturing infrastructure. We are among the top backward integrated exporters of pellets and have strong development and manufacturing capabilities.

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    202, 2nd Floor, B-Wing, Galaxy by Aurobindo Realty, Sy No 83/1, Hyderabad Know...
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    +91 4044758595
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    enquiries@cohance.com
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    https://cohance.com/
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/cohance-lifesciences-party-content-59687.pdf

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    Corporate Presentation

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      https://www.pharmacompass.com/pdf/party/content/cohance-lifesciences-party-content-62354.pdf

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    GMP Certificate 2024

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      https://www.pharmacompass.com/pdf/party/content/cohance-lifesciences-party-content-14233.pdf

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    FDF Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/cohance-lifesciences-party-content-35810.pdf

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    API Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/cohance-lifesciences-party-content-35932.pdf

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    Intermediate Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/cohance-lifesciences-party-content-40559.pdf

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    Pellet Product List 2024

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      https://www.pharmacompass.com/pdf/party/content/cohance-lifesciences-party-content-69896.pdf

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    Antibody-Drug Conjugate Brochure 2024

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    DATA COMPILATION #PharmaFlow

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    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    DMF filings hit all-time high in Q3 2024; China tops list with 58% increase in Type II submissions

    Drug Master Files, or DMFs, are confidential documents that play a crucial role in the pharmaceutical industry. These files, submitted to the US Food and Drug Administration (FDA), contain detailed information about ingredients, manufacturing processes, and packaging of medicines. They help the FDA oversee drug quality. Of the four types, Type II DMFs involve active pharmaceutical ingredients (APIs) for both branded and generic drugs. The third quarter (Q3) of 2024 saw Type II DMF submissions set a new record. A total of 309 Type II DMFs were submitted to the FDA during this period, a substantial 24.6 percent increase over Q3 2023 (with 248 submissions). The second quarter of 2024 too saw a remarkable increase, with 237 Type II DMFs being submitted compared to 178 in Q2 2023. View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) China witnesses steep rise in DMF submissions, beats India with maximum filings In Q3 2024, China filed 153 DMFs submissions, marking a substantial 57.7 percent increase from the 97 submissions filed in Q3 2023. India maintained its strong position but fell to the number two spot with 110 DMFs, representing a modest 3.8 percent increase from 106 in Q3 2023. The US, which came a distant third, saw a slight decline in DMF submissions, with 13 filed in Q3 2024, as compared to 18 in Q3 2023. For several years, India had a lead in Type II DMFs. Since 2020, which marked the start of the pandemic, we have noticed a gradual increase in DMFs filed by China. This year, China has surpassed India considerably in the first three quarters. During the first nine months of 2024, China submitted 372, while India filed 286 DMFs. If this lead is maintained in Q4, DMFs from China will surpass that of India in 2024.  Amongst European countries, Spain led with seven DMFs, followed by Italy at four, and Germany and the Netherlands at three each. Among other nations, Japan contributed six while Israel submitted four DMFs. In company-wise tally, China’s Jiangsu East-Mab Biomedical Technology topped the list with an impressive 14 DMFs. On its heels were Indian companies — MSN at 13 DMFs, and Vamsi Labs and Hetero Drugs at nine DMFs each. China’s Porton Pharma and Wuxi AppTec filed five, while Shanghai Keze Yongxin Biotechnology, and Qingdao Glycogene Pharmaceutical contributed four submissions each. India's Maithri Drugs also submitted four. Japanese company Santeja filed five. Overall, Asia accounted for nearly 90 percent, with China contributing a dominant 49.5 percent of all DMF submissions. India was at 35.6 percent, the US at 4.2 percent, while Europe contributed 6.5 percent.  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available) Diabetes, obesity, cancer, women’s health drugs emerge as hot molecules in Q3 2024 In terms of molecules, semaglutide (used for the treatment of type 2 diabetes and weight management) and relugolix (to treat prostate cancer and uterine fibroids) saw six DMF filings each in Q3 2024, indicating significant industry interest in these compounds. Following closely behind were semaglutide’s competitor tirzepatide and overactive bladder therapy vibegron, garnering four DMFs each. Finerenone (a non-steroidal drug for chronic kidney disease associated with type 2 diabetes) and voclosporin (an immunosuppressant for lupus nephritis) saw three DMFs each.  The last quarter also witnessed the introduction of 14 molecules with first-time DMFs. Among them were acetoxy empagliflozin, cabozantinib fumarate, tivozanib hydrochloride monohydrate, diosmetin, trilaciclib, clenbuterol hydrochloride, fenoterol hydrobromide, tapinarof and fezolinetant. Fezolinetant, with a DMF from Spain’s Moehs Iberica, is the active ingredient in Astellas’ Veozah, which is the first non-hormonal treatment for menopausal symptoms approved by the FDA. Tapinarof, filed by India’s Maithri Drugs, is used in Vtama, a novel steroid-free psoriasis cream. Other compounds that made their DMF debut include berotralstat, calcium phosphoryl choline chloride, phloroglucinol dihydrate, belumosudil mesylate and trimethylphloroglucinol. During Q2 2024, there were 19 drugs that saw DMF submissions for the first time, including molecules like triptorelin, sorafenib, pralsetinib, trilaciclib dihydrochloride, resmetirom (hepatology) and teneligliptin hydrochloride hydrate (metabolic disorders).  View FDA DMF Filings in Q3 2024 (Power BI Dashboard, Free Excel Available)    GDUFA fee for FY 2025: The FDA’s Generic Drug User Fee Amendments (GDUFA) is a law designed to speed access to safe and effective generic drugs to the public and reduce costs to the industry. The fiscal year 2025 fee rates were published on July 31, 2024. The FDA has revised fees under GDUFA III for all categories. While there is a slight increase in the DMF fee from US$ 94,682 in 2024 to US$ 95,084 in 2025, the ANDA fee has witnessed a significant jump — from US$ 252,453 in 2024 to US$ 321,920 in 2025. FY 2024 and FY 2025 User Fee Rates Generic drug fee category Fees rates for FY 2024 Fees rates for FY 2025 Applications: Abbreviated New Drug Application (ANDA) US$ 2,52,453   US$ 3,21,920   Drug Master File (DMF) US$ 94,682 US$ 95,084 Facilities: Active Pharmaceutical Ingredient (API)—Domestic US$ 40,464 US$ 41,580 API—Foreign US$ 55,464 US$ 56,580 Finished Dosage Form (FDF)—Domestic US$ 2,20,427   US$ 2,31,952 FDF—Foreign US$ 2,35,427   US$ 2,46,952 Contract Manufacturing Organization (CMO)—Domestic US$ 52,902 US$ 55,668 CMO—Foreign US$ 67,902 US$ 70,668 GDUFA Program: Large size operation generic drug applicant US$ 17,29,629   US$ 18,91,664 Medium size operation generic drug applicant US$ 6,91,852   US$ 7,56,666 Small business generic drug applicant US$ 1,72,963   US$ 1,89,166 Our view The highlight of the last few quarters has been the sharp rise in Type II DMF filings from China. The submission of a DMF is not required by law or any FDA regulation. FDA’s DMF guideline offers guidance on acceptable approaches to meeting regulatory requirements. Moreover, DMFs establish trust in APIs from lesser-known companies. With a growing emphasis on compliance and quality assurance, it appears that Chinese drug companies are eager to demonstrate their commitment to high standards and build trust in the US market. And that’s good news for the pharmaceutical industry.   
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    https://www.pharmacompass.com/radio-compass-blog/dmf-filings-hit-all-time-high-in-q3-2024-china-tops-list-with-58-increase-in-type-ii-submissions

    #PharmaFlow by PHARMACOMPASS
    24 Oct 2024
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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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    NEWS #PharmaBuzz

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    Suven, Cohance to Double Business Revenue to Rs 6,000 Cr by FY29
    Suven, Cohance to Double Business Revenue to Rs 6,000 Cr by FY29

    01 Nov 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/suven-cohance-aim-to-double-combined-business-revenue-to-rs-6000-cr-by-fy29/articleshow/114845104.cms

    ECONOMICTIMES
    01 Nov 2024
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    Cohance Lifesciences merger with Suven Pharma gets NSE, BSE nod
    Cohance Lifesciences merger with Suven Pharma gets NSE, BSE nod

    27 Jul 2024

    // TIMESOFINDIA

    https://timesofindia.indiatimes.com/business/india-business/cohance-lifesciences-merger-with-suven-pharma-gets-nse-bse-nod/articleshow/112068320.cms

    TIMESOFINDIA
    27 Jul 2024
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    Suven, with Cohance and more, wants to become a CDMO powerhouse
    Suven, with Cohance and more, wants to become a CDMO powerhouse

    02 Mar 2024

    // ECONOMIC TIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/suven-with-cohance-and-more-wants-to-become-a-cdmo-powerhouse-annaswamy-vaidheesh-executive-chairman/articleshow/108147698.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

    ECONOMIC TIMES
    02 Mar 2024
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    Suven-Cohance Lifesciences merger announced
    Suven-Cohance Lifesciences merger announced

    29 Feb 2024

    // PRESS RELEASE

    https://suvenpharm.com/pdf/events/SUVENPHAR_29022024190827_Suvenpharm_Pressrelease.pdf

    PRESS RELEASE
    29 Feb 2024
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    Advent Launches New Brand For Its API Platform
    Advent Launches New Brand For Its API Platform

    04 Jan 2023

    // PRESS RELEASE

    https://cohance.com/advent-international-launches-new-brand-for-its-api-platform-2/

    PRESS RELEASE
    04 Jan 2023
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    Advent launches Cohance Lifesciences, a new brand identity for its API platform
    Advent launches Cohance Lifesciences, a new brand identity for its API platform

    01 Nov 2022

    // PRESS RELEASE

    https://cohance.com/advent-international-launches-cohance-lifesciences-a-new-brand-identity-for-its-api-platform/

    PRESS RELEASE
    01 Nov 2022
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    ALL APIs

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    01

    Rivaroxaban

    India

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

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    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 32115

    Submission : 2017-10-02

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : CEP 2020-274 - Rev 02

    Issue Date : 2024-06-28

    Type : Chemical

    Substance Number : 2932

    Status : Valid

     JDMF arrow-down
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    Registration Number : 304MF10154

    Registrant's Address : 215 Atrium, C Wing, 8th Floor, 819-821, Andheri Kurla Road, Chakala MIDC, Chakala, Andheri East, Mumbai-400 093 Maharash

    Initial Date of Registration : 2022-12-07

    Latest Date of Registration :

    EU-WCarrow-down
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    Date of Issue : 2022-08-25

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 76072-1008

    Start Marketing Date : 2017-06-05

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : M-Peak Korea Co., Ltd.

    Registration Date : 2023-12-11

    Registration Number : Number 812-22-ND

    Manufacturer Name : ZCL Chemicals Limited

    Manufacturer Address : Plot No. 3102/B GIDC, Industrial Estate Ankleshwar-393 002, Dist. Bharuch, Gujarat state, India

     VMF CN arrow-down
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    Available Reg. Filing : CN
    AUDIT
    Cohance

    Product
    Web Link

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    Market
    Place

    02

    Aripiprazole

    India

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

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    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-11-16

    Pay. Date : 2017-10-18

    DMF Number : 30120

    Submission : 2015-12-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2016-021 - Rev 02

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 2617

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-25

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76072-1002

    Start Marketing Date : 2016-04-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2018-03-16

    Registration Number : 20180316-209-J-68

    Manufacturer Name : ZCL Chemicals Limited

    Manufacturer Address : Plot No. 3102/B GIDC, Industrial Estate Ankleshwar-393 002, Dist. Bharuch, Gujarat state, India

     VMF Others AUDIT
    Cohance

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    03

    Atomoxetin Hydrochloride

    India

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

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    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-27

    Pay. Date : 2019-12-03

    DMF Number : 29211

    Submission : 2015-03-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2015-150 - Rev 01

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-25

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 76072-1011

    Start Marketing Date : 2017-06-05

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF CN, CA arrow-down
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    Available Reg. Filing : CN, CA
    AUDIT
    Cohance

    Product
    Web Link

    Stock Recap
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    Place

    04

    Dipyridamole

    India

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

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    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-18

    Pay. Date : 2015-09-29

    DMF Number : 29745

    Submission : 2015-09-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-148 - Rev 01

    Issue Date : 2022-12-16

    Type : Chemical

    Substance Number : 1199

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-07

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0150

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-122

    Start Marketing Date : 2020-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF CN, RU, ... arrow-down
    ✖
    Available Reg. Filing : CN, RU, AU
    AUDIT
    Cohance

    Product
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    05

    Doxazosin Mesylate

    India

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

    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2019-12-31

    Pay. Date : 2019-12-23

    DMF Number : 22941

    Submission : 2009-07-10

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2010-312 - Rev 03

    Issue Date : 2023-10-27

    Type : Chemical

    Substance Number : 2125

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-07

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0150

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-113

    Start Marketing Date : 2009-07-31

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF VMF CN, RU arrow-down
    ✖
    Available Reg. Filing : CN, RU
    AUDIT
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    Market
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    06

    Entacapone

    India

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

    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-05-24

    Pay. Date : 2015-09-29

    DMF Number : 23937

    Submission : 2010-06-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-337 - Rev 03

    Issue Date : 2022-12-15

    Type : Chemical

    Substance Number : 2574

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-07

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0150

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-109

    Start Marketing Date : 2010-07-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT FOR ...

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2019-03-20

    Registration Number : 20190320-209-J-208

    Manufacturer Name : Cohance Lifesciences Limited

    Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, NTR District-521 457, Andhra Pradesh, India

     VMF CN arrow-down
    ✖
    Available Reg. Filing : CN
    AUDIT
    Cohance

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    Market
    Place

    07

    Fluvoxamine

    India

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

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    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2018-01-04

    Pay. Date : 2017-10-18

    DMF Number : 29582

    Submission : 2015-07-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2014-089 - Rev 04

    Issue Date : 2024-09-27

    Type : Chemical

    Substance Number : 1977

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-25

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0195

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 76072-1003

    Start Marketing Date : 2016-04-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
    Cohance

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    Market
    Place

    08

    Itraconazole

    India

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

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    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-10-19

    Pay. Date : 2013-03-11

    DMF Number : 25986

    Submission : 2012-04-20

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-165 - Rev 02

    Issue Date : 2023-04-04

    Type : Chemical

    Substance Number : 1335

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-07

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0150

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-114

    Start Marketing Date : 2020-01-20

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF MX, APAC arrow-down
    ✖
    Available Reg. Filing : MX, APAC
    AUDIT
    Cohance

    Product
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    Market
    Place

    09

    Lamotrigine

    India

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

    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-29

    Pay. Date : 2013-03-20

    DMF Number : 23251

    Submission : 2009-11-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-417 - Rev 00

    Issue Date : 2022-12-15

    Type : Chemical

    Substance Number : 1756

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-07

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0150

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-103

    Start Marketing Date : 2022-02-14

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Wonpung Pharmaceutical Co., Ltd.

    Registration Date : 2022-12-12

    Registration Number : 20220112-209-J-1158(A)

    Manufacturer Name : Cohance Lifescience Limited

    Manufacturer Address : API Unit-I, RS 50/1, Mukteswarapuram Village, Jaggaiahpet Mandal, NTR District – 521 457, Andhra Pradesh, India

     VMF CN arrow-down
    ✖
    Available Reg. Filing : CN
    AUDIT
    Cohance

    Product
    Web Link

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    Market
    Place

    10

    Midazolam

    India

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

    arrow
    Pharmatech Expo 2025
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-09-03

    Pay. Date : 2015-02-12

    DMF Number : 26871

    Submission : 2013-02-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-141 - Rev 02

    Issue Date : 2022-12-15

    Type : Chemical

    Substance Number : 936

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-07

    Valid Till : 2025-07-21

    Written Confirmation Number : WC-0150

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 17511-115

    Start Marketing Date : 2020-01-17

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2021-03-25

    Registration Number : 20210325-210-J-815

    Manufacturer Name : Cohance Lifesciences Limited

    Manufacturer Address : RS 50/1, Mukteswarapuram Village, Jaggaiahpeta Mandal, NTR District-521 457, Andhra Pradesh, India

     VMF Others AUDIT
    Cohance

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    CEP/COS

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    01

    Aripiprazole

    India
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    Duphat
    Not Confirmed
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    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : CEP 2016-021 - Rev 02

    Status : Valid

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 2617

    Cohance

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    02

    Articaine hydrochloride

    India
    arrow
    Duphat
    Not Confirmed
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    • EDQM
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : R1-CEP 2015-311 - Rev 01

    Status : Valid

    Issue Date : 2022-12-16

    Type : Chemical

    Substance Number : 1688

    Cohance

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    03

    Atomoxetine hydrochloride

    India
    arrow
    Duphat
    Not Confirmed
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    • EDQM
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : CEP 2015-150 - Rev 01

    Status : Valid

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 2640

    Cohance

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    04

    Atomoxetine hydrochloride, Process 2

    India
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    Duphat
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : CEP 2019-212 - Rev 02

    Status : Valid

    Issue Date : 2024-07-10

    Type : Chemical

    Substance Number : 2640

    Cohance

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    05

    Baclofen

    India
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    Duphat
    Not Confirmed
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    • EDQM
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : R0-CEP 2018-280 - Rev 01

    Status : Valid

    Issue Date : 2022-12-15

    Type : Chemical

    Substance Number : 653

    Cohance

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    06

    Betahistine dihydrochloride

    India
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    Duphat
    Not Confirmed
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    • EDQM
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : CEP 2013-240 - Rev 02

    Status : Valid

    Issue Date : 2024-07-09

    Type : Chemical

    Substance Number : 1665

    Cohance

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    07

    Clozapine

    India
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    Duphat
    Not Confirmed
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : R0-CEP 2018-192 - Rev 01

    Status : Valid

    Issue Date : 2021-02-12

    Type : Chemical

    Substance Number : 1191

    Cohance

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    Market
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    08

    Dapsone

    India
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    Duphat
    Not Confirmed
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : CEP 2020-358 - Rev 01

    Status : Valid

    Issue Date : 2024-07-10

    Type : Chemical

    Substance Number : 77

    Cohance

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    09

    Dipyridamole

    India
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    Duphat
    Not Confirmed
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    • EDQM
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : R1-CEP 2014-148 - Rev 01

    Status : Valid

    Issue Date : 2022-12-16

    Type : Chemical

    Substance Number : 1199

    Cohance

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    10

    Doxazosin mesilate

    India
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    Duphat
    Not Confirmed
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    • EDQM
    • WHO-GMP
    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Cohance Lifesciences

    Certificate Numbers : CEP 2010-312 - Rev 03

    Status : Valid

    Issue Date : 2023-10-27

    Type : Chemical

    Substance Number : 2125

    Cohance

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    Drugs in Development

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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Avra Laboratories Gets Regulatory Approval for Covid-19 Drug Favipiravir

    Details:

    Ciplenza (favipiravir-generic) is a RNA-directed RNA polymerase inhibitor, small molecule, which is indicated for the treatment of patients with Covid-19 infection.


    Lead Product(s): Favipiravir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Ciplenza

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 27, 2020

    Cohance

    01

    Cohance Lifesciences

    India
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    Virtual BoothCohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

    Lead Product(s) : Favipiravir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Avra Laboratories Gets Regulatory Approval for Covid-19 Drug Favipiravir

    Details : Ciplenza (favipiravir-generic) is a RNA-directed RNA polymerase inhibitor, small molecule, which is indicated for the treatment of patients with Covid-19 infection.

    Brand Name : Ciplenza

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 27, 2020

    Cohance

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    KEY PRODUCTS

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    Services

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    Clinical Trials

    Discover their expertise for : Clinical Trials

    API Manufacturing

    Discover their expertise for : API Manufacturing

    API & Drug Product Development

    Discover their expertise for : API & Drug Product Development

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
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    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-08-02

    Cohance Lifesciences

    City : Krishna District,

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-08-02

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    02

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-10-11

    Cohance Lifesciences

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-10-11

    Cohance

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    03

    FDA Audited

    USA
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    Duphat
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-05

    Cohance Lifesciences

    City : Hyderabad

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-03-05

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    04

    FDA Audited

    USA
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    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-09-18

    Cohance Lifesciences

    City : Ankleshwar

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-09-18

    Cohance

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    05

    FDA Audited

    USA
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    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-08-23

    Cohance Lifesciences

    City : Ankleshwar

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-08-23

    Cohance

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    06

    FDA Audited

    USA
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    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-10-11

    Cohance Lifesciences

    City : Uppal Mandal, Medchal-Mal...

    State :

    Country/Area : IN

    Zip :

    District :

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2013-10-11

    Cohance

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    07

    FDA Audited

    USA
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    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-08-02

    Cohance Lifesciences

    City : Krishna District

    State :

    Country/Area : IN

    Zip :

    District :

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-08-02

    Cohance

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    08

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-04-01

    Cohance Lifesciences

    City : Krishna District

    State :

    Country/Area : IN

    Zip :

    District :

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-04-01

    Cohance

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    Data Compilation
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    09

    FDA Audited

    USA
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    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-07-12

    Cohance Lifesciences

    City : Uppal Mandal, Medchal-Mal...

    State :

    Country/Area : IN

    Zip :

    District :

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2016-07-12

    Cohance

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    10

    FDA Audited

    USA
    arrow
    Duphat
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-02-06

    Cohance Lifesciences

    City : Uppal Mandal, Medchal-Mal...

    State :

    Country/Area : IN

    Zip :

    District :

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2018-02-06

    Cohance

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    Data Compilation
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    ABOUT THIS PAGE

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    Cohance Lifesciences is a supplier offers 106 products (APIs, Excipients or Intermediates).

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