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    Company profile for Sun Pharmaceutical Industries Limited

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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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    FAMAR CDMO- From early development to commercial manufacturing.

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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    About

    We were pioneers among Indian pharmaceutical companies to see tremendous value in investing in research & development (R&D). Our early investments in R&D, beginning three decades ago, enabled us to make technology our key differentiator and develop a basket of robust products for diverse markets across the world. Our core strength lies in our ability to excel in developing generics and technologically complex products through ...
    We were pioneers among Indian pharmaceutical companies to see tremendous value in investing in research & development (R&D). Our early investments in R&D, beginning three decades ago, enabled us to make technology our key differentiator and develop a basket of robust products for diverse markets across the world. Our core strength lies in our ability to excel in developing generics and technologically complex products through focused teams in formulations, process chemistry and analytical development. We have the capability to deliver quality products within established timelines, at low costs and without compromising on quality.

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    Sun Pharmaceutical Industries Limitedindia-flag Flag
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    Sun House, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400...
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    +91-22-4324 4324, +91 22 6696 9696
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

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    https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

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    16 Dec 2024
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    FDA’s first generic approvals slump 21% in 2024; Novartis’ top seller Entresto, cancer blockbuster Tasigna lead 2024 patent cliff

    A watershed moment in the journey of a drug is when it transitions from being a patented, high‐priced innovator product to an affordable generic.Through an inaugural approval, or a “first generic”,  the US Food Drug Administration (FDA) permits a manufacturer to market a generic version of a brand‐name drug — a process that, when successful, grants 180 days of exclusivity to the generic sponsor. This exclusivity is especially valuable when the drug in question is a blockbuster.In FDA’s fiscal year 2024 (i.e. from October 1, 2023 to September 30, 2024), the number of first-time generic drug approvals decreased by 21.3 percent — from 89 in FY 2023 to 70 in FY 2024, the lowest in at least nine years.Lupin emerged as a frontrunner in first generics, increasing its approvals from three in FY 2023 to seven in FY 2024, Apotex and Zydus Lifesciences from four to six, and Dr. Reddy’s from two to four. In contrast, Teva, Amneal, and Sun Pharma experienced a decline.Overall, neurology led the way with 10 approvals, while immunology saw eight, including three approvals in dermatology. Oncology and cardiology/vascular disease saw six approvals each. Ophthalmology saw five while psychiatry, and infectious diseases each contributed four approvals. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Novartis’ top seller Entresto, blockbuster Tasigna among six key drugs hit by generic rivalsIn 2024, the tide turned sharply for Novartis as it lost exclusivity for six of its drugs. Among them was its blockbuster Entresto, that has generated US$ 29.2 billion in revenue so far, including US$ 7.8 billion in 2024.A combination of sacubitril and valsartan, Entresto has transformed heart failure management. Entresto was the primary driver of Novartis’ sales growth last year. It was also one of the 10 drugs selected by the Biden administration in 2023 for Medicare price negotiations. Novartis has been fighting a fierce legal battle to protect Entresto from generic competition. In 2024, Entresto’s generic saga reached a crescendo. Alembic Pharmaceuticals, Laurus Labs, and Crystal Pharmaceutical’s generic versions of Entresto received FDA approval in May last year. But the Swiss drugmaker has noted that as of January 2025, there were no Entresto generics available in the US.Novartis’ Tasigna (nilotinib) has been a cornerstone in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Apotex won approvals for generics of 50 mg, 150 mg, and 200 mg of nilotinib formulations, thereby offering a more affordable option for both adult and pediatric patients. Owing to the generics, Tasigna’s sales fell 10 percent in 2024.Novartis’ Mekinist (trametinib), Votrient (pazopanib), Rydapt (midostaurin), and Promacta (eltrombopag) have long been critical treatments in oncology and hematology. With generic competition hitting these key assets, Novartis is now aggressively forging deals to strengthen its pipeline. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  FDA clears first generics for Neurocrine’s Ingrezza, Supernus’s Gocovri, ALS drugsIn psychiatry, Neurocrine Biosciences’ Ingrezza (valbenazine) capsules have carved out a niche for themselves as a first-in-class treatment for tardive dyskinesia, a movement disorder that can develop as a side effect of long-term use of antipsychotic meds. Two generics for Ingrezza from India’s Zydus and Lupin bagged FDA approval, as Ingrezza sales topped US$ 2.3 billion last year.Zydus also won first generic approval for Supernus Pharmaceuticals’ Gocovri (amantadine) extended-release capsules, which is a treatment of dyskinesia in Parkinson’s disease patients receiving levodopa-based therapy.Four companies received FDA approvals for their first generics of Mitsubishi Tanabe’s patented drug Radicava (edaravone). These are Dr. Reddy’s Laboratories, Gland Pharma (a Fosun Pharmaceutical subsidiary), Hikma and Long Grove. Radicava is a drug that treats amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. Another treatment for ALS from Italfarmaco — Tiglutik (riluzole) — received a first generic when FDA okayed Alkem Laboratories riluzole oral suspension. The med helps slow disease progression. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Pfizer’s Ibrance, Gilead’s Descovy, Lilly’s Olumiant treatment come under generic pressureIn oncology, Synthon Pharmaceuticals launched its generic version of Pfizer’s Ibrance (palbociclib) tablets. Generating sales of US$ 4.4 billion in 2024, this groundbreaking CDK4/6 inhibitor is Pfizer’s best-selling cancer drug. It has transformed treatment for hormone receptor-positive, HER2-negative advanced breast cancer by halting cancer cell division and significantly extending progression-free survival when combined with endocrine therapy.Descovy, a combination of emtricitabine and tenofovir alafenamide, stands as one of the most important therapies in the fight against HIV infection and related conditions. Originally developed by Gilead Sciences, Descovy has played a pivotal role in modern antiretroviral therapy, contributing US$ 2.1 billion to Gilead’s revenue in 2024. Apotex’s first generic approval for Descovy marked its second copycat for a blockbuster drug in 2024. The other generic approval it got its hands on was for Boehringer Ingelheim’s Pradaxa (dabigatran etexilate), a blood thinner that posted sales of € 845 million (US$ 883 million) in 2023.In immunology, Eli Lilly’s Olumiant (baricitinib) has emerged as an important therapy for treating inflammatory conditions such as rheumatoid arthritis. Aurobindo Pharma bagged FDA approval for generic baricitinib tablets.Ipsen’s Somatuline Depot (lanreotide) injection, a treatment for neuroendocrine tumors and endocrine disorders that generated about € 1.07 billion (US$1.1 billion) in 2023 sales, also has a generic now, with Cipla’s subsidiary InvaGen Pharmaceuticals receiving an FDA approval. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available) FDA okays copycats for opioid withdrawal med Lucemyra, weight loss drug Qsymia, contraceptive SlyndFDA also demonstrated a focused commitment to addressing two of the nation’s biggest public health concerns — the opioid crisis and obesity. Lucemyra (lofexidine), originally developed by US WorldMeds, is a non-opioid medication indicated for mitigating symptoms associated with acute opioid withdrawal and facilitating the completion of opioid discontinuation treatment. The introduction of Indoco Remedies’ generic version is poised to expand access to this critical therapy by offering a cost-effective alternative for managing substance use disorders.Vivus’ Qsymia (phentermine/topiramate), a chronic weight management therapy, also received a first generic. Actavis’ generic for Qsymia provides a more accessible option to patients striving to lose weight. Actavis is a subsidiary of Teva.FDA also approved Lupin’s first generic version of Insud Pharma’s Slynd—a progestin‑only contraceptive containing 4 mg drospirenone for use by females of reproductive potential to prevent pregnancy. View First Generic Drug Approvals by FDA in FY 2024 (Free Excel Available)  Our viewOver the next two years, several blockbusters such as Novo Nordisk’s Ozempic (semaglutide), AstraZeneca’s Farxiga (dapagliflozin), Bristol Myers Squibb’s Revlimid (lenalidomide) and its Pfizer partnered drug Eliquis (apixaban) stand to lose their patent protection. We expect more patent litigations and some exciting innovations in the generics space.
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    https://www.pharmacompass.com/radio-compass-blog/fda-s-first-generic-approvals-slump-21-in-2024-novartis-top-seller-entresto-cancer-blockbuster-tasigna-lead-2024-patent-cliff

    #PharmaFlow by PHARMACOMPASS
    20 Feb 2025
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    NEWS #PharmaBuzz

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    'Discover And Make In India' To Drive Pharma Innovation
    'Discover And Make In India' To Drive Pharma Innovation

    14 Feb 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/discover-and-make-in-india-to-drive-innovation-in-pharma-says-dilip-shanghvi-founder-managing-director-sun-pharmaceutical-industries/articleshow/118257057.cms

    ECONOMICTIMES
    14 Feb 2025
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    Sun Pharma elevates Aalok Shanghvi as COO
    Sun Pharma elevates Aalok Shanghvi as COO

    03 Feb 2025

    // ECONOMICTIMES

    https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/sun-pharma-elevates-aalok-shanghvi-as-coo/articleshow/117890251.cms

    ECONOMICTIMES
    03 Feb 2025
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    Sun Pharma’s Q3 Profit Beats Estimates with Strong Local Sales
    Sun Pharma’s Q3 Profit Beats Estimates with Strong Local Sales

    31 Jan 2025

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/indias-top-drugmaker-sun-pharmas-q3-profit-beats-estimates-strong-local-sales-2025-01-31/

    REUTERS
    31 Jan 2025
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    Sun Pharma subsidiary Taro acquires Antibe Therapeutics
    Sun Pharma subsidiary Taro acquires Antibe Therapeutics

    16 Jan 2025

    // EXPRESSPHARMA

    https://www.expresspharma.in/sun-pharma-subsidiary-taro-acquires-antibe-therapeutics/

    EXPRESSPHARMA
    16 Jan 2025
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    Sun Pharma opens training & production centre in Jammu
    Sun Pharma opens training & production centre in Jammu

    07 Jan 2025

    // EXPRESSPHARMA

    https://www.expresspharma.in/sun-pharma-opens-training-production-centre-in-jammu/

    EXPRESSPHARMA
    07 Jan 2025
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    Sun Pharma sells entire stake in Japanese arm to Zaza Industries
    Sun Pharma sells entire stake in Japanese arm to Zaza Industries

    02 Jan 2025

    // BUSINESS STD

    https://www.business-standard.com/companies/news/sun-pharma-sells-entire-stake-in-japanese-arm-to-zaza-industrial-holdings-125010101001_1.html

    BUSINESS STD
    02 Jan 2025
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    ALL APIs

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    01

    Gemcitabine

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

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    Gemcitabine

    India

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

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    USDMF arrow-down Click Us! arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 19427

    Submission : 2006-05-16

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2007-021 - Rev 02

    Issue Date : 2024-06-12

    Type : Chemical

    Substance Number : 2306

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 221MF10018

    Registrant's Address : SUN HOUSE, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Maharashtra, India

    Initial Date of Registration : 2009-01-28

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

    Written Confirmation Number : WC-0159

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Repure Healthcare Co., Ltd.

    Registration Date : 2021-07-11

    Registration Number : 20210711-86-D-159-24

    Manufacturer Name : Sun Pharmaceutical Industries Ltd.

    Manufacturer Address : A-7/A-8, MIDC Industrial Area, Ahmednagar 414111, Maharashtra State, India

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    02

    Tramadol Hydrochloride

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

    Biotech Digital Meet
    Not Confirmed
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    Tramadol Hydrochloride

    India

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

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16002

    Submission : 2002-06-06

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-003 - Rev 00

    Issue Date : 2022-04-25

    Type : Chemical

    Substance Number : 1681

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10018

    Registrant's Address : SUN HOUSE, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Maharashtra, India

    Initial Date of Registration : 2014-01-21

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

    Written Confirmation Number : WC-0159

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Humedics Co., Ltd.

    Registration Date : 2018-01-22

    Registration Number : 20120608-161-I-50-01(7)

    Manufacturer Name : Sun Pharmaceutical Industries Ltd.

    Manufacturer Address : A-7/A-8 MIDC Industrial Area, Ahmednagar, Maharashtra 414111

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    03

    Clarithromycin

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

    Biotech Digital Meet
    Not Confirmed
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    Clarithromycin

    India

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

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16563

    Submission : 2003-05-02

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2006-246 - Rev 05

    Issue Date : 2024-02-15

    Type : Chemical

    Substance Number : 1651

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10255

    Registrant's Address : Plot No. 90, Sector 32, Gurgaon, Haryana 122 001, India　

    Initial Date of Registration : 2008-12-12

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-07-04

    Written Confirmation Number : WC-0216

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    04

    Meropenem

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

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    Meropenem

    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 : 21194

    Submission : 2007-12-24

    Status : Inactive

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R0-CEP 2018-268 - Rev 01

    Issue Date : 2022-12-19

    Type : Chemical

    Substance Number : 2234

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 220MF10004

    Registrant's Address : SUN HOUSE, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Maharashtra, India

    Initial Date of Registration : 2008-01-09

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-06

    Valid Till : 2025-07-04

    Written Confirmation Number : WC-0216

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    05

    Mesalazine

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

    Biotech Digital Meet
    Not Confirmed
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    Mesalazine

    India

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

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16431

    Submission : 2003-02-17

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2003-267 - Rev 06

    Issue Date : 2023-02-20

    Type : Chemical

    Substance Number : 1699

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10100

    Registrant's Address : SUN HOUSE, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Maharashtra, India

    Initial Date of Registration : 2007-03-14

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

    Written Confirmation Number : WC-0159

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62756-115

    Start Marketing Date : 2020-12-30

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (50kg/50kg)

    Marketing Category : BULK INGREDIENT

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    06

    Midazolam

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

    Biotech Digital Meet
    Not Confirmed
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    Midazolam

    India

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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15170

    Submission : 2000-11-29

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2002-059 - Rev 05

    Issue Date : 2021-09-14

    Type : Chemical

    Substance Number : 936

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 219MF10137

    Registrant's Address : SUN HOUSE, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063, Maharashtra, India

    Initial Date of Registration : 2007-04-18

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-06-02

    Written Confirmation Number : WC-0011nA2

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    07

    Ofloxacin

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

    Biotech Digital Meet
    Not Confirmed
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    Ofloxacin

    India

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

    arrow
    Biotech Digital Meet
    Not Confirmed
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    • EDQM
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 14240

    Submission : 1999-06-25

    Status : Inactive

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2000-106 - Rev 09

    Issue Date : 2024-02-28

    Type : Chemical

    Substance Number : 1455

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 217MF11127

    Registrant's Address : Plot No. 90, Sector 32, Gurgaon, Haryana 122 001, India

    Initial Date of Registration : 2005-12-05

    Latest Date of Registration :

    EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-06-02

    Written Confirmation Number : WC-0011nA2

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    08

    Metformin

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Metformin

    India

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

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    Biotech Digital Meet
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    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-11

    Pay. Date : 2012-11-23

    DMF Number : 15612

    Submission : 2001-08-25

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-223 - Rev 00

    Issue Date : 2022-05-17

    Type : Chemical

    Substance Number : 931

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

    Written Confirmation Number : WC-0159

    Address of the Firm :

    NDC KDMF arrow-down
    ✖

    Registrant Name : Hwaduk Pharmaceutical Co., Ltd.

    Registration Date : 2005-08-31

    Registration Number : 20050831-37-C-30-02

    Manufacturer Name : Sun Pharm. Ltd

    Manufacturer Address : A7/A-8, MIDC INDUSTRIES AREA, AHMEDNAGAR-414 111, MAHARASHTRA, INDIA

     VMF Others AUDIT
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    09

    Metoprolol Tartrate

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Metoprolol Tartrate

    India

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

    arrow
    Biotech Digital Meet
    Not Confirmed
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15995

    Submission : 2002-05-18

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2018-086 - Rev 02

    Issue Date : 2024-03-25

    Type : Chemical

    Substance Number : 1028

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-06-08

    Valid Till : 2025-07-25

    Written Confirmation Number : WC-0159

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    10

    Mirtazapine

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

    Biotech Digital Meet
    Not Confirmed
    arrow

    Mirtazapine

    India

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

    arrow
    Biotech Digital Meet
    Not Confirmed
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    • EDQM
    • WHO-GMP
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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16113

    Submission : 2002-08-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2010-293 - Rev 00

    Issue Date : 2018-04-05

    Type : Chemical

    Substance Number : 2338

    Status : Valid

     JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-08-08

    Valid Till : 2025-07-14

    Written Confirmation Number : WC-0168

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    Excipients

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    Inspections and registrations

    Upload your audits for free, ask us

    FDA

    read-more
    read-more

    01

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-05-04

    Chattem Chemicals, Inc

    City : Chattanooga

    State : TN

    Country/Area : US

    Zip : 37409-1248

    District : NOL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-05-04

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    02

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-20

    Sun Pharmaceutical Industries Limited

    City : Cranbury

    State : NJ

    Country/Area : US

    Zip : 08512-3605

    District : NWJ

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2017-03-20

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    03

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-10

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : HU

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-10

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    04

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-02

    Chattem Chemicals, Inc

    City : Chattanooga

    State : TN

    Country/Area : US

    Zip : 37409-1248

    District : NOL

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2017-03-02

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    05

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-07-15

    Sun Pharmaceutical Industries Limited

    City : Cranbury

    State : NJ

    Country/Area : US

    Zip : 08512-3605

    District : NWJ

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-07-15

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    06

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-08

    Sun Pharmaceutical Industries Limited

    City : Vadodara

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-05-08

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    07

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-30

    Sun Pharmaceutical Industries Limited

    City : Dadra

    State :

    Country/Area : IN

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-30

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    08

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-13

    Sun Pharmaceutical Industries Limited

    City : Billerica

    State : MA

    Country/Area : US

    Zip : 01821-5729

    District : NWE

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2015-01-13

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    09

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
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    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-09-17

    Sun Pharmaceutical Industries Limited

    City : Bedford

    State : MA

    Country/Area : US

    Zip : 01730-2203

    District : NWE

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2014-09-17

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    10

    FDA Audited

    USA
    Biotech Digital Meet
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    Biotech Digital Meet
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-22

    Alkaloida Chemical Company Zrt

    City : Tiszavasvari

    State :

    Country/Area : HU

    Zip :

    District : ORA

    Center : CDER

    Project Area : Drug Quality Assurance

    District Decision : No Action Indicated

    Inspection End Date : 2014-05-22

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    ABOUT THIS PAGE

    Contact Sun Pharmaceutical Industries Limited and get a quotation

    Sun Pharmaceutical Industries Limited is a supplier offers 396 products (APIs, Excipients or Intermediates).

    Find a price of Gemcitabine bulk with DMF, CEP, JDMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Tramadol Hydrochloride bulk with DMF, CEP, JDMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Clarithromycin bulk with CEP, JDMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Mesalazine bulk with CEP, JDMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Midazolam bulk with CEP, JDMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Buprenorphine Hydrochloride bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Cilazapril bulk with CEP, JDMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Clomipramine Hydrochloride bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Desloratadine bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Divalproex Sodium bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Esomeprazole Sodium bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Leuprolide Acetate bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Metformin bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Metoprolol Succinate bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Metoprolol Tartrate bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Mirtazapine bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Naloxone Hydrochloride bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Octreotide Acetate bulk with DMF, JDMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Ondansetron Hydrochloride bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Oxaliplatin bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Pantoprazole Sodium bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Repaglinide bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Rosuvastatin Calcium bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Sumatriptan bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Tramadol Hydrochloride bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Venlafaxine Hydrochloride bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Zolpidem Tartrate bulk with DMF, CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Atorvastatin bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Benazepril Hydrochloride bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Candesartan Cilexetil bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Cefuroxime Axetil bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Cilastatin Sodium bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Ciprofloxacin Hydrochloride bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Levofloxacin bulk with JDMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Metoprolol Succinate bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Sertraline Hydrochloride bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Sodium Valproate bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Solifenacin Succinate bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Abiraterone Acetate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Amitriptyline Hydrochloride bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Bupropion Hydrochloride bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Cinacalcet Hydrochloride bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Cisplatin bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Citalopram Hydrobromide bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Clopidogrel bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Dabigatran Etexilate Mesylate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Decitabine bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Desmopressin Acetate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Dimethyl Fumarate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Donepezil bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Exemestane bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Fampridine bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Fluvastatin Sodium bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Fosphenytoin Sodium bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Gabapentin bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Ganirelix bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Hydroxyprogesterone Caproate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Imatinib Mesylate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

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    Find a price of Lacosamide bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Lenalidomide bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Levalbuterol Hydrochloride bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Levetiracetam bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Levocetirizine Dihydrochloride bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Linagliptin bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Liothyronine Sodium bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Lithium Carbonate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Loratadine bulk with DMF, CEP offered by Sun Pharmaceutical Industries Limited

    Find a price of Losartan Potassium bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Loteprednol Etabonate bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Lubiprostone bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Meloxicam bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Memantine Hydrochloride bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Metaxalone bulk with DMF, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Methylphenidate Hydrochloride bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Metoprolol Tartrate bulk with CEP, WC offered by Sun Pharmaceutical Industries Limited

    Find a price of Naloxone Hydrochloride bulk with DMF, CEP offered by Sun Pharmaceutical Industries Limited

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