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    Company profile for Zydus Lifesciences

    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    About

    Zydus Cadila is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin...
    Zydus Cadila is headquartered in Ahmedabad, India, and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil. Zydus’ global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and in the high profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.

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    Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Nr....
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

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    09 Nov 2024
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    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities

    Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 
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    21 Nov 2024
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    NEWS #PharmaBuzz

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    Supreme Court Asks Zydus to Approach Delhi HC Over Sigrima Ban
    Supreme Court Asks Zydus to Approach Delhi HC Over Sigrima Ban

    19 Nov 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/supreme-court-asks-zydus-lifesciences-to-approach-delhi-hc-over-ban-on-selling-breast-cancer-drug-sigrima/articleshow/115421732.cms

    ECONOMICTIMES
    19 Nov 2024
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    Zydus Lifesciences Reports 14% Profit Rise, 22% R&D Increase
    Zydus Lifesciences Reports 14% Profit Rise, 22% R&D Increase

    12 Nov 2024

    // FINANCIALXPRESS

    https://www.financialexpress.com/business/healthcare-q2fy25-zydus-lifesciences-reports-profit-rises-14-percent-to-rs-911-crore-rd-investments-up-22-percent-q-o-q-3662967/

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    12 Nov 2024
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    India's Zydus Life posts Q2 profit rise on steady US demand
    India's Zydus Life posts Q2 profit rise on steady US demand

    12 Nov 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-zydus-life-posts-q2-profit-rise-steady-us-demand-2024-11-12/

    REUTERS
    12 Nov 2024
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    High Court reinstates Injunction stopping sale of Zydus’ Sigrima
    High Court reinstates Injunction stopping sale of Zydus’ Sigrima

    29 Oct 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/delhi-high-court-reinstates-injunction-stopping-sale-of-zydus-sigrima/

    EXPRESSPHARMA
    29 Oct 2024
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    Zydus gets WHO nod for its typhoid vaccine
    Zydus gets WHO nod for its typhoid vaccine

    23 Oct 2024

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/zydus-lifesciences-gets-who-prequalification-for-typhoid-vi-conjugate-vaccine/articleshow/114492728.cms

    ECONOMICTIMES
    23 Oct 2024
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    Zydus Receives WHO Acceptability For ZyVac TCV For UN Purchases
    Zydus Receives WHO Acceptability For ZyVac TCV For UN Purchases

    23 Oct 2024

    // EXPRESSPHARMA

    https://www.expresspharma.in/zydus-receives-who-acceptability-for-zyvac-tcv-eligible-for-un-agency-purchases/

    EXPRESSPHARMA
    23 Oct 2024
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    ALL APIs

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    01

    Mesalazine

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

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    Mesalazine

    India

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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-08-08

    Pay. Date : 2012-12-18

    DMF Number : 22999

    Submission : 2009-07-31

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2019-009 - Rev 02

    Issue Date : 2024-07-05

    Type : Chemical

    Substance Number : 1699

    Status : Valid

     JDMF arrow-down
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    Registration Number : 303MF10044

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2021-03-15

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-08

    Valid Till : 2022-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

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    02

    Paroxetine Hydrochloride

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

    BioFlorida Conference
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    Paroxetine Hydrochloride

    India

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

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    BioFlorida Conference
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16680

    Submission : 2003-06-27

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-239 - Rev 06

    Issue Date : 2022-07-08

    Type : Chemical

    Substance Number : 2018

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 222MF10207

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2010-07-26

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-15

    Valid Till : 2022-07-14

    Written Confirmation Number : WC-0084

    Address of the Firm :

    NDC KDMF arrow-down
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    Registrant Name : Nuri Pharm Tech

    Registration Date : 2021-11-30

    Registration Number : 20211130-209-J-1162

    Manufacturer Name : Zydus Lifesciences Limited

    Manufacturer Address : 291, GIDC, Estate, Ankleshwar, Gujarat, 393002, India

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    03

    Tramadol Hydrochloride

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

    BioFlorida Conference
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    Tramadol Hydrochloride

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17037

    Submission : 2004-02-17

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2004-098 - Rev 05

    Issue Date : 2024-07-16

    Type : Chemical

    Substance Number : 1681

    Status : Valid

     JDMF arrow-down
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    Registration Number : 301MF10065

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2019-09-17

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-08

    Valid Till : 2022-07-07

    Written Confirmation Number : WC-0095

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    04

    Valsartan

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

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    Valsartan

    India

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 22684

    Submission : 2009-03-31

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2020-221 - Rev 00

    Issue Date : 2023-04-04

    Type : Chemical

    Substance Number : 2423

    Status : Valid

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    Registration Number : 225MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2013-07-23

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

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    05

    Atomoxetin Hydrochloride

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

    BioFlorida Conference
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    Atomoxetin Hydrochloride

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20364

    Submission : 2007-03-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-236 - Rev 01

    Issue Date : 2022-07-11

    Type : Chemical

    Substance Number : 2640

    Status : Valid

     JDMF arrow-down
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    Registration Number : 303MF10088

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103, Nr. Nirma University, Nr. Vaishnod

    Initial Date of Registration : 2021-06-07

    Latest Date of Registration :

    EU-WC NDC arrow-down
    ✖

    NDC Package Code : 65841-155

    Start Marketing Date : 2018-01-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2016-03-30

    Registration Number : No. 4749-10-ND(1)

    Manufacturer Name : Cadila Pharmaceuticals Limited

    Manufacturer Address : 294, GIDC Estate, City: Ankleshwar-393 002, Dist: Bharuch, India.

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    06

    Atorvastatin

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

    BioFlorida Conference
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    Atorvastatin

    India

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

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18822

    Submission : 2005-09-30

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-079 - Rev 02

    Issue Date : 2024-08-29

    Type : Chemical

    Substance Number : 2191

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0080

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    07

    Losartan Potassium

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

    BioFlorida Conference
    Not Confirmed
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    Losartan Potassium

    India

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

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    BioFlorida Conference
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 18153

    Submission : 2005-03-04

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2009-133 - Rev 08

    Issue Date : 2023-03-23

    Type : Chemical

    Substance Number : 2232

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 223MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2011-08-30

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-08

    Valid Till : 2022-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Goodwills Co., Ltd.

    Registration Date : 2011-01-10

    Registration Number : 20110110-122-G-94-29

    Manufacturer Name : Cadila Healthcare Limited

    Manufacturer Address : 291, GIDC Industrial Estate Ankleswar-393 002, Gujarat INDIA

     VMF Others AUDIT
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    08

    Atenolol

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

    BioFlorida Conference
    Not Confirmed
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    Atenolol

    India

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

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    BioFlorida Conference
    Not Confirmed
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-04-01

    Pay. Date : 2016-03-22

    DMF Number : 14210

    Submission : 1999-06-14

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2004-169 - Rev 04

    Issue Date : 2022-07-07

    Type : Chemical

    Substance Number : 703

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-15

    Valid Till : 2022-07-14

    Written Confirmation Number : WC-0084

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65841-101

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    09

    Hydroxychloroquine Sulphate

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

    BioFlorida Conference
    Not Confirmed
    arrow

    Hydroxychloroquine Sulphate

    India

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

    arrow
    BioFlorida Conference
    Not Confirmed
    • fda
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14977

    Submission : 2000-08-01

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-011 - Rev 01

    Issue Date : 2022-07-08

    Type : Chemical

    Substance Number : 2849

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2021-07-29

    Valid Till : 2022-07-14

    Written Confirmation Number : WC-0084A5

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65841-103

    Start Marketing Date : 2017-09-27

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Seongi Bio Co., Ltd.

    Registration Date : 2020-06-17

    Registration Number : 20200206-209-J-553(1)

    Manufacturer Name : Cadila Healthcare Limited

    Manufacturer Address : Plot No.: 26 to 29 & 31, Dabhasa Tal - Padra, City: Dabhasa, 391440, Dist: Vadodara, Gujarat State, India

     VMF Others AUDIT
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    10

    Meloxicam

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

    BioFlorida Conference
    Not Confirmed
    arrow

    Meloxicam

    India

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

    arrow
    BioFlorida Conference
    Not Confirmed
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2017-02-01

    Pay. Date : 2017-01-10

    DMF Number : 17358

    Submission : 2004-05-05

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2019-017 - Rev 03

    Issue Date : 2023-07-17

    Type : Chemical

    Substance Number : 2373

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-08

    Valid Till : 2022-07-07

    Written Confirmation Number : WC-0095

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 65841-004

    Start Marketing Date : 2020-01-28

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    USDMF

    read-more
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    01

    Albendazole Usp

    India
    BioFlorida Conference
    Not Confirmed
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    02

    Alfuzosin Hydrochloride

    India
    BioFlorida Conference
    Not Confirmed
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    03

    Amlodipine Besilate Usp

    India
    BioFlorida Conference
    Not Confirmed
    arrow

    04

    Amlodipine Besylate Usp

    India
    BioFlorida Conference
    Not Confirmed
    arrow

    05

    Anagrelide Hydrochloride Usp

    India
    BioFlorida Conference
    Not Confirmed
    arrow

    06

    Anastrozole

    India
    BioFlorida Conference
    Not Confirmed
    arrow

    07

    Apalutamide

    India
    BioFlorida Conference
    Not Confirmed
    arrow

    08

    Apixaban

    India
    BioFlorida Conference
    Not Confirmed
    arrow

    Apixaban

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-09-19

    Pay. Date : 2016-06-16

    DMF Number : 30630

    Submission : 2016-07-06

    Status : Active

    Type : II

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    09

    Apremilast

    India
    BioFlorida Conference
    Not Confirmed
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    10

    Aripiprazole Usp

    India
    BioFlorida Conference
    Not Confirmed
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    CEP/COS

    read-more
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    01

    Amlodipine besilate

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    02

    Aripiprazole

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    03

    Atenolol

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    04

    Atomoxetine hydrochloride

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    05

    Atorvastatin calcium, Process I

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    06

    Atorvastatin calcium, Process II

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    07

    Atorvastatin calcium, Process-III

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    08

    Atorvastatin calcium, Process-IV

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    09

    Azelastine hydrochloride

    CEP/COS

    BioFlorida Conference
    Not Confirmed
    arrow

    10

    Benzoyl Peroxide, Hydrous

    CEP/COS

    BioFlorida Conference
    Not Confirmed
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    JDMF

    read-more
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    01

    Atomoxetine Hydrochloride

    JDMF

    BioFlorida Conference
    Not Confirmed
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    Atomoxetine Hydrochloride

    India
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    BioFlorida Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Zydus Lifesciences

    Registration Number : 303MF10088

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103,...

    Initial Date of Registration : 2021-06-07

    Latest Date of Registration : 2021-06-07

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    Market
    Place

    02

    Losartan potassium

    JDMF

    BioFlorida Conference
    Not Confirmed
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    Losartan potassium

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Zydus Lifesciences

    Registration Number : 223MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2011-08-30

    Latest Date of Registration : 2011-08-30

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    Market
    Place

    03

    Mesalazine

    JDMF

    BioFlorida Conference
    Not Confirmed
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    Mesalazine

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Zydus Lifesciences

    Registration Number : 303MF10044

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103,...

    Initial Date of Registration : 2021-03-15

    Latest Date of Registration : 2021-03-15

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    Market
    Place

    04

    Paroxetine Hydrochloride Hydrate

    JDMF

    BioFlorida Conference
    Not Confirmed
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    Paroxetine Hydrochloride Hydrate

    India
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    BioFlorida Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Zydus Lifesciences

    Registration Number : 222MF10207

    Registrant's Address : Zydus Corporate Park, 3rd Floor, B Wing, Scheme No. 63, Survey No. 536, Plot No. 103,...

    Initial Date of Registration : 2010-07-26

    Latest Date of Registration : 2017-09-25

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    05

    Pitavastatin calcium

    JDMF

    BioFlorida Conference
    Not Confirmed
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    Pitavastatin calcium

    India
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    BioFlorida Conference
    Not Confirmed
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    Virtual Booth Virtual Booth
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    Zydus Lifesciences

    Registration Number : 224MF10187

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2012-09-03

    Latest Date of Registration : 2012-09-03

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    Market
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    06

    Tramadol Hydrochloride

    JDMF

    BioFlorida Conference
    Not Confirmed
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    Tramadol Hydrochloride

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    Registration Number : 301MF10065

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2019-09-17

    Latest Date of Registration : 2019-11-15

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    07

    Valsartan

    JDMF

    BioFlorida Conference
    Not Confirmed
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    Valsartan

    India
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    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    Registration Number : 225MF10140

    Registrant's Address : “Zydus Tower”, Satellite Cross Roads, Ahmedabad 380015, India

    Initial Date of Registration : 2013-07-23

    Latest Date of Registration : 2013-07-23

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    NDC API

    read-more
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    01

    AMLODIPINE BESYLATE

    India
    BioFlorida Conference
    Not Confirmed
    arrow

    AMLODIPINE BESYLATE

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-014

    Start Marketing Date : 2024-09-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    02

    ANAGRELIDE HYDROCHLORIDE

    India
    BioFlorida Conference
    Not Confirmed
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    ANAGRELIDE HYDROCHLORIDE

    India
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    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-106

    Start Marketing Date : 2024-09-18

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    03

    ARIPIPRAZOLE

    India
    BioFlorida Conference
    Not Confirmed
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    ARIPIPRAZOLE

    India
    arrow
    BioFlorida Conference
    Not Confirmed
    • fda
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    • WHO-GMP
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    Zydus Lifesciences

    NDC Package Code : 65841-140

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    Market
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    04

    ATENOLOL

    India
    BioFlorida Conference
    Not Confirmed
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    ATENOLOL

    India
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    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-101

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    ATOMOXETINE HYDROCHLORIDE

    India
    BioFlorida Conference
    Not Confirmed
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    ATOMOXETINE HYDROCHLORIDE

    India
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    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-155

    Start Marketing Date : 2018-01-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    ATOVAQUONE

    India
    BioFlorida Conference
    Not Confirmed
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    ATOVAQUONE

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-158

    Start Marketing Date : 2024-09-19

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    07

    AZELASTINE HYDROCHLORIDE

    India
    BioFlorida Conference
    Not Confirmed
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    AZELASTINE HYDROCHLORIDE

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-164

    Start Marketing Date : 2018-01-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    08

    BOSENTAN

    India
    BioFlorida Conference
    Not Confirmed
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    BOSENTAN

    India
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    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-176

    Start Marketing Date : 2018-01-12

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    09

    BUPROPION

    India
    BioFlorida Conference
    Not Confirmed
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    BUPROPION

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-131

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    10

    CLINDAMYCIN HYDROCHLORIDE

    India
    BioFlorida Conference
    Not Confirmed
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    CLINDAMYCIN HYDROCHLORIDE

    India
    arrow
    BioFlorida Conference
    Not Confirmed
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    Zydus Lifesciences

    NDC Package Code : 65841-139

    Start Marketing Date : 2018-01-11

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    FDA Orange Book

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    01

    Brand Name : ABACAVIR SULFATE AND...

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ABACAVIR SULFATE AND...

    U.S.A
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    RLD : No

    TE Code :

    ABACAVIR SULFATE; LAMIVUDINE

    Zydus Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : ABACAVIR SULFATE AND LAM...

    Dosage Strength : EQ 600MG BASE;300MG

    Approval Date : 2018-11-15

    Application Number : 208990

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    02

    Brand Name : ACAMPROSATE CALCIUM

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACAMPROSATE CALCIUM

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    RLD : No

    TE Code : AB

    ACAMPROSATE CALCIUM

    Zydus Pharmaceuticals

    Dosage Form : TABLET, DELAYED RELEASE; ORAL

    Proprietary Name : ACAMPROSATE CALCIUM

    Dosage Strength : 333MG

    Approval Date : 2017-05-26

    Application Number : 205995

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    03

    Brand Name : ACETAMINOPHEN

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACETAMINOPHEN

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    RLD : No

    TE Code :

    ACETAMINOPHEN

    Zydus Pharmaceuticals

    Dosage Form : SOLUTION; INTRAVENOUS

    Proprietary Name : ACETAMINOPHEN

    Dosage Strength : 1GM/100ML (10MG/ML)

    Approval Date : 2022-10-25

    Application Number : 216467

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    04

    Brand Name : TRAMADOL HYDROCHLORI...

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : TRAMADOL HYDROCHLORI...

    U.S.A
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    RLD : No

    TE Code : AB

    ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

    Zydus Pharmaceuticals

    Dosage Form : TABLET; ORAL

    Proprietary Name : TRAMADOL HYDROCHLORIDE A...

    Dosage Strength : 325MG;37.5MG

    Approval Date : 2012-09-06

    Application Number : 90460

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    05

    Brand Name : ACETAZOLAMIDE

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACETAZOLAMIDE

    India
    Pharmtech & Ingredients
    Not Confirmed
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    RLD : No

    TE Code : AB

    ACETAZOLAMIDE

    Zydus Lifesciences

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAZOLAMIDE

    Dosage Strength : 125MG

    Approval Date : 2023-04-04

    Application Number : 211069

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    06

    Brand Name : ACETAZOLAMIDE

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACETAZOLAMIDE

    India
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    RLD : No

    TE Code : AB

    ACETAZOLAMIDE

    Zydus Lifesciences

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACETAZOLAMIDE

    Dosage Strength : 250MG

    Approval Date : 2023-04-04

    Application Number : 211069

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    07

    Brand Name : ACETAZOLAMIDE SODIUM

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACETAZOLAMIDE SODIUM

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    RLD : No

    TE Code : AP

    ACETAZOLAMIDE SODIUM

    Zydus Pharmaceuticals

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : ACETAZOLAMIDE SODIUM

    Dosage Strength : EQ 500MG BASE/VIAL

    Approval Date : 2019-04-15

    Application Number : 206533

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    08

    Brand Name : ACETYLCYSTEINE

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACETYLCYSTEINE

    U.S.A
    Pharmtech & Ingredients
    Not Confirmed
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    RLD : No

    TE Code : AP

    ACETYLCYSTEINE

    Zydus Pharmaceuticals

    Dosage Form : INJECTABLE; INTRAVENOUS

    Proprietary Name : ACETYLCYSTEINE

    Dosage Strength : 6GM/30ML (200MG/ML)

    Approval Date : 2018-07-20

    Application Number : 208166

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    09

    Brand Name : ACYCLOVIR

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
    Pharmtech & Ingredients
    Not Confirmed
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Zydus Lifesciences

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 400MG

    Approval Date : 2013-11-15

    Application Number : 202168

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    Brand Name : ACYCLOVIR

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : ACYCLOVIR

    India
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    RLD : No

    TE Code : AB

    ACYCLOVIR

    Zydus Lifesciences

    Dosage Form : TABLET; ORAL

    Proprietary Name : ACYCLOVIR

    Dosage Strength : 800MG

    Approval Date : 2013-11-15

    Application Number : 202168

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AB

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    South Africa

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    01

    Brand Name : Aldren 70 Tablets

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : Aldren 70 Tablets

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Alendronic Acid

    Zydus Lifesciences

    Dosage Form : TAB

    Dosage Strength : 70mg

    Packaging : 4X1mg

    Brand Name : Aldren 70 Tablets

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    02

    Brand Name : Zyvasc 5/160

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : Zyvasc 5/160

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Amlodipine

    Zydus Lifesciences

    Dosage Form : FCT

    Dosage Strength : 5mg

    Packaging : 30X1mg

    Brand Name : Zyvasc 5/160

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    03

    Brand Name : Zyvasc 10/160

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : Zyvasc 10/160

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Amlodipine

    Zydus Lifesciences

    Dosage Form : FCT

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Brand Name : Zyvasc 10/160

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    04

    Brand Name : Amlodac 5

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : Amlodac 5

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Amlodipine

    Zydus Lifesciences

    Dosage Form : TAB

    Dosage Strength : 5mg

    Packaging : 30X1mg

    Brand Name : Amlodac 5

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Amlodac 10

    India
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    Brand Name : Amlodac 10

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Amlodipine

    Zydus Lifesciences

    Dosage Form : TAB

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Brand Name : Amlodac 10

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Castra 1

    India
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : Castra 1

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Anastrozole

    Zydus Lifesciences

    Dosage Form : FCT

    Dosage Strength : 1mg

    Packaging : 30X1mg

    Brand Name : Castra 1

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Zyquis 2.5

    India
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    Brand Name : Zyquis 2.5

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Apixaban

    Zydus Lifesciences

    Dosage Form : TAB

    Dosage Strength : 2.5mg

    Packaging : 60X1mg

    Brand Name : Zyquis 2.5

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Zyquis 5

    India
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    Brand Name : Zyquis 5

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Apixaban

    Zydus Lifesciences

    Dosage Form : TAB

    Dosage Strength : 5mg

    Packaging : 60X1mg

    Brand Name : Zyquis 5

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Aridus 10

    India
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    Brand Name : Aridus 10

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Aripiprazole

    Zydus Lifesciences

    Dosage Form : ODT

    Dosage Strength : 10mg

    Packaging : 30X1mg

    Brand Name : Aridus 10

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Brand Name : Aridus 15

    India
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    Brand Name : Aridus 15

    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Aripiprazole

    Zydus Lifesciences

    Dosage Form : ODT

    Dosage Strength : 15mg

    Packaging : 30X1mg

    Brand Name : Aridus 15

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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