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    About

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    “Our unmatched efficiency and track record of faster DMF filings give our customers a critical competitive advantage”

    This week, SpeakPharma interviews Pete Werth III, the new president of ChemWerth, a company that has been at the forefront of the generic pharmaceutical industry for over four decades. He shares his vision for ChemWerth, which includes his commitment to strengthening global manufacturing relationships, and enhancing supply chain resilience. Additionally, he highlights the key aspects of a successful drug master file (DMF). HIGHLIGHTS// Pete Werth III, the new president of ChemWerth/ vision for ChemWerth/ commitment to strengthening global manufacturing relationships/ key aspects of a successful drug master file Your father, Peter J. Werth, is recognized as one of the founders of the generic pharmaceutical industry, having built ChemWerth from the ground up over four decades ago. How do you view his legacy? As you take the helm, what key lessons or principles from his leadership do you intend to carry forward? My father, Peter J. Werth, is a true pioneer in the generic pharmaceutical industry. Over his 42‐year tenure, he not only built ChemWerth from a humble garage startup into a global leader in generic API development but also established standards that many in our industry now take for granted. Under his leadership, we filed our very first DMF in 1987 and have since achieved more than 500 DMF filings. With an average review cycle of just 0.79, we have been far outperforming the industry average of 2.5 cycles. His focus on quality, regulatory excellence, and a relentless commitment to customers’ success set the foundation for our reputation as a trusted supplier of over 500 APIs sourced from more than 30 cGMP-certified facilities worldwide. Equally inspiring is his dedication to nurture long-term, mutually beneficial relationships with manufacturing partners across the US, Europe, India, and China, as well as his passion for giving back to the community through philanthropic initiatives. As I take the helm, I intend to build on his guiding principles — sustaining our high standards of quality and compliance while pursuing innovation in regulatory strategy, diversifying our supply chain, and embracing new technologies and approaches to remain competitive in an evolving market. I will also strive to continue his legacy of mentorship, ensuring that our company culture remains rooted in integrity and diligence, with an unyielding focus on making safe, affordable medicines available worldwide. HIGHLIGHTS// trusted supplier of over 500 APIs/ 30 cGMP-certified facilities worldwide/ embracing new technologies and approaches to remain competitive What are your top priorities as the new president of ChemWerth? How do you plan to strengthen and expand relationships with manufacturers worldwide? My immediate priorities as the new president are twofold: to enhance the value we deliver to our customers and, to deepen our relationships with our manufacturing partners worldwide. We will further diversify our supply chain and broaden our product portfolio. Our expansion plans include upgrading equipment, and hiring additional highly skilled scientists, engineers, and GMP auditors. We will also leverage our proprietary product selection and regulatory submission processes. These processes help us get the regulatory filing right the first time, and allows us to be approved 44 percent faster than the industry average. This helps our customers gain a competitive edge in the market. In essence, by strengthening operational excellence and expanding our global network, we intend to continue the company’s long-standing commitment to customer success and process innovation. We plan to reinforce our long-standing relationships with our manufacturers — especially those in strategic markets like China and India — by helping our partners meet the highest standards of regulatory compliance and current good manufacturing practice (cGMP) quality. This balanced approach of strengthening existing partnerships while pioneering new ones is key to maintaining and growing our competitive edge. HIGHLIGHTS// diversify our supply chain and broaden our product portfolio/ commitment to customer success and process innovation/ filings approved 44 percent faster than the industry average When ChemWerth last spoke to PharmaCompass, there was a mention of investing millions of dollars in expanding manufacturing partnerships in China and India. Can you elaborate on the success of these partnerships, and how have they contributed to ChemWerth’s overall growth? Our strategic, multimillion-dollar investments in manufacturing partnerships are a cornerstone of our growth strategy. Over the past few years, these joint ventures have proven their worth by diversifying our supply base and mitigating the risk of global supply chain disruptions — a lesson that became all too clear during the Covid-19 pandemic. These investments are already paying dividends. They help us support manufacturers producing steroids, hormones, veterinary products, and large-volume APIs, while also accelerating the development of small-molecule inhibitors and new generic APIs. We have ensured that our partners are equipped with the latest equipment and trained personnel to meet cGMP standards. By partnering with facilities in these markets, we now have access to state-of-the-art production capabilities that enable us to produce a wider range of APIs at competitive costs. The success of these partnerships is evident in our ability to consistently file DMFs rapidly — often on the first cycle — and deliver affordable, high-quality medicines to patients worldwide. This supports our clients’ growth trajectory and has helped us expand into new markets. This strategy has reinforced our global footprint — supporting our presence in 38 countries with over 100 products — and positioned us well to capitalize on a global generic drug market projected to grow at a compounded annual growth rate of 5.4 percent from 2022 to 2030, to reach a size of US$ 671 billion by 2030. HIGHLIGHTS// strategic multimillion-dollar investments/ support manufacturers producing steroid, hormone, veterinary products/ development of small-molecule inhibitors and new generic APIs/ ensured partners are equipped with the latest equipment and trained personnel ChemWerth has an impressive track record, and an over 40-year relationship with the US Food and Drug Administration (FDA). What are the key aspects of a successful DMF? Are there specific challenges manufacturers face in preparing DMFs, and how does ChemWerth help them overcome these hurdles? ChemWerth’s record of filing over 500 DMFs in 38 countries reflects our commitment to excellence in regulatory compliance and quality management. A successful DMF is built on comprehensive documentation that rigorously follows cGMP guidelines, robust analytical validation, and detailed tracking of every step. Every DMF we file meticulously details the entire manufacturing process — from raw material acquisition to final batch production. This comprehensive approach ensures that our submissions meet the rigorous quality, safety, and efficacy standards expected by the FDA. Our team stays continuously updated on the evolving guidelines and protocols, which allows us to file DMFs that align with current FDA practices. We recognize that many manufacturers face challenges such as complex regulatory requirements, lengthy review cycles, and the need for precise coordination between various production stages. ChemWerth helps them overcome these hurdles by offering end-to-end regulatory support, detailed internal audits, and continuous training on cGMP and FDA requirements. Our efficiency is a critical competitive advantage. By receiving approvals 44 percent faster than the industry average, we help our customers get their products to market faster, resulting in larger market share and increased profits. HIGHLIGHTS// over 500 DMFs in 38 countries/ robust analytical validation/ end-to-end regulatory support What is your vision for ChemWerth over the next few years? How do you plan to navigate the challenges and opportunities in the generic pharmaceutical industry? I plan to continue to add value for our customers, and look for innovative ways to compete in today’s generic pharmaceutical landscape. At ChemWerth, our vision for the future is rooted in both our proud legacy and our relentless drive for innovation. We will further diversify our supply chain and expand our product portfolio. We have begun leveraging our expertise to supply APIs for biosimilars and new drug applications (NDAs), while maintaining our reputation for rapid regulatory approvals. With unwavering determination, we uphold our “First to Quality. Fast to Market.” approach — delivering high-quality APIs to customers worldwide while leveraging our expertise to give them a competitive edge in their markets. HIGHLIGHTS// supply APIs for biosimilars and NDAs/ give customers a competitive edge in their markets 

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    12 Mar 2025
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    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    AI drug discovery market to grow 30% CAGR, to reach US$ 35 bn by 2034; Novo, Lilly, BMS forge deals

    Artificial intelligence (AI) is emerging as a transformative force in drug discovery and development. The global AI in drug discovery market was valued at US$ 1.99 billion in 2024 and is estimated to reach US$ 2.65 billion in 2025. Going forward, the market is expected to grow at an impressive compounded annual growth rate (CAGR) of 29.6 percent, to reach a market size of US$ 35.42 billion by 2034, says a report by Polaris Market Research. This growth expectation mirrors the eagerness within the biopharma industry to leverage AI in order to overcome the traditional barriers of lengthy timelines, exorbitant costs, and high failure rates. This eagerness is also being manifested in deal making — Big Pharma has been busy forging alliances with AI-driven drug discovery companies. Over the last two years, almost every big drugmaker, including Novo Nordisk, Merck, BMS, Pfizer, AstraZeneca, Otsuka Pharmaceutical, Novartis and Sanofi, has signed deals with various AI drug discovery companies. PharmaCompass' compilation shows there are scores of molecules discovered by AI currently in discovery and developmental phases, demonstrating the technology's growing impact on pharmaceutical pipelines.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available) Novo, Lilly, BMS invest in AI partnerships; Recursion, Exscientia merge to create AI powerhouse With the transformative potential of AI becoming increasingly evident, we witnessed a slew of deals in the biopharma industry over the last six months. A significant deal in the AI drug discovery space was the merger of two leaders — Recursion and Exscientia — that took place in November last year. Exscientia is now a wholly-owned subsidiary of Recursion. The merger has created a global technology-enabled drug discovery leader with end-to-end capabilities. The merged entity has over 10 clinical and preclinical programs, and around 10 advanced discovery programs in the pipeline.  Apart from this merger, several large drugmakers have struck deals with AI drug discovery firms since September last year. For instance, in January this year, Valo Health and Novo Nordisk expanded their collaboration to discover and develop novel treatments for cardiometabolic diseases. This deal, valued at up to US$ 4.8 billion, aims to harness the power of AI and extensive human datasets. Building on their initial 2023 partnership, it will enable the development of up to 20 drug programs.  Similarly, Pfizer, which is already big on AI, extended its AI drug discovery pact with PostEra and also partnered IgnitionAI to enhance drug discovery — all within the last six months. And Novartis struck a drug discovery deal with Generate BioMedicines in September. Insilico Medicine has been actively forging partnerships. In January, Insilico entered a second exclusive global license agreement with Menarini Group for an AI-discovered preclinical asset targeting high unmet needs in oncology. Insilico also has a tie-up with Sanofi, dating back to 2022. In December 2024, AI Proteins announced a research collaboration and option agreement with BMS to design and optimize mini-proteins for therapeutic use. And in September, Eli Lilly joined hands with Genetic Leap to accelerate the development of genetic medicines. Lilly will leverage Genetic Leap’s RNA-targeted AI platform to generate oligonucleotide drugs against selected targets.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  AI leads to faster target identification; Insilico, BenevolentAI’s candidates in trials Computational biology, and especially AI, has fundamentally changed the drug discovery paradigm. The traditional method of drug discovery used to take 13 to 15 years, costing an average of US$ 2.5 billion in investment before a drug got approved and launched in the market. Additionally, less than 10 percent of candidates in phase 1 clinical trials used to end up getting approved by the US Food and Drug Administration (FDA). All that has begun to change. According to Khair ElZarrad, Director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research, since 2016, FDA has received approximately 300 submissions that reference AI use as of May 2024. These submissions range from drug development, drug discovery, clinical research, clinical trials as well as post-market safety surveillance and manufacturing. Though we are yet to witness an AI-generated candidate translate into an approved therapy, target identification in drug discovery is visibly becoming a lot faster. This is the process that identifies specific molecules or pathways in the human body that are linked to a disease. The best example of dramatic acceleration of timelines is Insilico Medicine’s development of INS018_055, a candidate for idiopathic pulmonary fibrosis that entered phase 2 trials in June 2023. Using their AI platform PandaOmics, researchers at Insilico compressed target identification from years to just 18 months. Similarly, BenevolentAI successfully employed their AI platform to identify a new target for ulcerative colitis, leading to the development of BEN-8744, a candidate that has been in phase 1a clinical trials since August 2023.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Oncology leads AI drug discovery market; Recursion shows how to repurpose drugs using AI The integration of AI in oncology research has been impactful, accounting for the largest revenue share (about 22.4 percent) in the AI drug discovery market in 2023. AI technologies have accelerated the discovery and development of new cancer treatments, bolstered personalized medicine approaches, and improved clinical trial designs in the arena of this complex disease.  Another promising application is drug repurposing, where AI can identify new therapeutic applications for existing drugs. Recursion Pharmaceuticals’ REC-2282 exemplifies this approach. This therapy is currently in phase 2/3 studies for neurofibromatosis type 2 (a genetic condition that causes tumors to grow along nerves). By repurposing compounds already vetted for safety, this strategy can bypass early-stage failures, reducing both time and cost compared to developing entirely new molecules. However, the use of AI in drug discovery is not without challenges. Exscientia’s EXS-21546, designed to treat solid tumors, entered phase 1/2 trials in 2020 but was discontinued in 2023 after modeling suggested that achieving a suitable therapeutic index would be difficult. Though this is a clinical failure, it highlights AI’s value in identifying potential failures earlier on in the development process, saving resources that would have otherwise been spent on later-stage trials.  Access the Dashboard on AI-Discovered Drug Candidates (Free Excel Available)  Our view The Covid-19 pandemic was a time when humanity felt the urgent need to speed up the process of drug discovery, testing and approvals. It also hastened the process of integrating AI into pharmaceutical research, leading to the launch of Covid vaccines in record time. Today, there is no looking back — AI is bringing about a paradigm shift in how drugs are discovered. With increasing reliance on AI, there is hope that drug discovery will be more accurate, efficient and less time and cost consuming.
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    Impressions: 481

    https://www.pharmacompass.com/radio-compass-blog/ai-drug-discovery-market-to-grow-30-cagr-to-reach-us-35-bn-by-2034-novo-lilly-bms-forge-deals

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    13 Mar 2025
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    NEWS #PharmaBuzz

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    Shilpa Medicare’s Unit Receives GMP Certificate from EMA, Austria
    Shilpa Medicare’s Unit Receives GMP Certificate from EMA, Austria

    22 Dec 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicares-unit-vii-nacharam-hyderabad-receives-gmp-certificate-from-ema-austria-16564

    INDPHARMAPOST
    22 Dec 2024
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    Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI
    Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

    28 Nov 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicares-jv-oncosol-gets-usfda-approval-for-imkeldi-16490

    INDPHARMAPOST
    28 Nov 2024
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    Shilpa Medicare as Subsidiary Gets EU Nod for Blood Pressure Drug
    Shilpa Medicare as Subsidiary Gets EU Nod for Blood Pressure Drug

    19 Nov 2024

    // CNBCTV

    https://www.cnbctv18.com/market/shilpa-medicare-stock-rallies-as-subsidiary-gets-european-regulators-nod-for-blood-pressure-drug-19511446.htm

    CNBCTV
    19 Nov 2024
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    Shilpa Medicare Q2 FY25 consolidated PAT up 1,008% at Rs. 18 Cr
    Shilpa Medicare Q2 FY25 consolidated PAT up 1,008% at Rs. 18 Cr

    15 Nov 2024

    // INDPHARMAPOST

    https://www.indianpharmapost.com/news/shilpa-medicare-q2-fy25-consolidated-pat-up-1008-at-rs-18-cr-16437

    INDPHARMAPOST
    15 Nov 2024
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    Shilpa Medicare Falls After FDA Issues 4 Observations at Facility
    Shilpa Medicare Falls After FDA Issues 4 Observations at Facility

    31 Oct 2024

    // BUSINESS STD

    https://www.business-standard.com/markets/capital-market-news/shilpa-medicare-slips-after-us-fda-issues-four-form-483-obersvations-to-bengaluru-facility-124103100642_1.html

    BUSINESS STD
    31 Oct 2024
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    Amneal and Shilpa Announce FDA Approval Of BORUZU, Ready-to-Use
    Amneal and Shilpa Announce FDA Approval Of BORUZU, Ready-to-Use

    05 Sep 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20240905166831/en

    BUSINESSWIRE
    05 Sep 2024
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    ALL APIs

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    01

    Busulfan

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

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    Busulfan

    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 : Reviewed

    Rev. Date : 2013-07-02

    Pay. Date : 2012-12-19

    DMF Number : 25491

    Submission : 2011-12-07

    Status : Active

    Type : II

     CEP/COS arrow-down
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    Certificate Number : R1-CEP 2011-339 - Rev 02

    Issue Date : 2022-07-20

    Type : Chemical

    Substance Number : 542

    Status : Valid

     JDMF arrow-down
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    Registration Number : 230MF10027

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India

    Initial Date of Registration : 2018-02-15

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 82920-008

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF VMF Others AUDIT
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    02

    Capecitabine

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

    European Pharma Congress
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    Capecitabine

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-07-07

    Pay. Date : 2013-02-21

    DMF Number : 24689

    Submission : 2011-03-24

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2014-332 - Rev 02

    Issue Date : 2023-02-07

    Type : Chemical

    Substance Number : 2762

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 229MF10131

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2017-07-19

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-001

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
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    Registrant Name : Masung LS Co., Ltd.

    Registration Date : 2021-04-20

    Registration Number : 20210420-209-J-850

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot Nos. 33, 33a, 40-47, Raichur Industrial Growth Centre, Chicksugur-584 134, Raichur, India

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    03

    Gemcitabine

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

    European Pharma Congress
    Not Confirmed
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    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-11

    Pay. Date : 2012-12-18

    DMF Number : 24136

    Submission : 2011-03-04

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2017-187 - Rev 02

    Issue Date : 2024-01-04

    Type : Chemical

    Substance Number : 2306

    Status : Valid

     JDMF arrow-down
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    Registration Number : 221MF10017

    Registrant's Address : 10/80, RAJENDRA GUNJ, RAICHUR-584 102, INDIA

    Initial Date of Registration : 2009-01-13

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
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    NDC Package Code : 82920-701

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Lee Yeon Pharmaceutical Co., Ltd.

    Registration Date : 2012-10-05

    Registration Number : 20080110-86-D-2-05(2)

    Manufacturer Name : Shilpa Medicare Limited

    Manufacturer Address : Plot No. 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosugur - 584 170, Dist: Raichur, India

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    04

    Letrozole

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

    European Pharma Congress
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    Letrozole

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-15

    Pay. Date : 2013-09-23

    DMF Number : 27489

    Submission : 2013-09-26

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2013-321 - Rev 01

    Issue Date : 2022-07-20

    Type : Chemical

    Substance Number : 2334

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 226MF10029

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2014-02-05

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

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    05

    Temozolomide

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

    European Pharma Congress
    Not Confirmed
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    Temozolomide

    India

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

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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-09-10

    Pay. Date : 2013-09-03

    DMF Number : 23479

    Submission : 2010-01-22

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2016-277 - Rev 00

    Issue Date : 2022-07-12

    Type : Chemical

    Substance Number : 2780

    Status : Valid

     JDMF arrow-down
    ✖

    Registration Number : 228MF10125

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2016-07-12

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-703

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Hwail Pharmaceutical Co., Ltd.

    Registration Date : 2013-07-26

    Registration Number : 1414-4-ND(2)

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot No.: 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosugur- 584 170 Dist: Raichur, Karnataka, India

     VMF Others AUDIT
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    Market
    Place

    06

    Azacitidine

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

    European Pharma Congress
    Not Confirmed
    arrow

    Azacitidine

    India

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

    arrow
    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-03-15

    Pay. Date : 2013-09-23

    DMF Number : 27487

    Submission : 2013-09-23

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 303MF10033

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India

    Initial Date of Registration : 2021-02-16

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-015

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Samyang Holdings Co., Ltd.

    Registration Date : 2018-06-25

    Registration Number : No. 163-15-ND(1)

    Manufacturer Name : Shilpa Medicare Limited

    Manufacturer Address : Plot No.33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, Chicksugur - 584 134 Dist: Raichur, Karnataka India

     VMF Others AUDIT
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    Market
    Place

    07

    Bicalutamide

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

    European Pharma Congress
    Not Confirmed
    arrow

    Bicalutamide

    India

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

    arrow
    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-04-04

    Pay. Date : 2013-09-23

    DMF Number : 24690

    Submission : 2011-05-11

    Status : Active

    Type : II

     CEP/COS JDMF arrow-down
    ✖

    Registration Number : 225MF10084

    Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584 135, Karnataka, India

    Initial Date of Registration : 2013-04-23

    Latest Date of Registration :

    EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-004

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2021-10-25

    Registration Number : 20211025-209-J-1105

    Manufacturer Name : Shilpa Pharma Lifesciences Limited (unit-2)

    Manufacturer Address : Plot No. 33, 33A, 40 to 47, Block C,D,E,H,I & AM, Raichur Industrial Growth Centre, Chicksugur - 584 134 Dist: Raichur. Karnataka India

     VMF Others AUDIT
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    Market
    Place

    08

    Irinotecan Hydrochloride

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

    European Pharma Congress
    Not Confirmed
    arrow

    Irinotecan Hydrochloride

    India

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

    arrow
    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-01-09

    Pay. Date : 2012-12-18

    DMF Number : 23562

    Submission : 2010-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2017-147 - Rev 00

    Issue Date : 2023-07-04

    Type : Chemical

    Substance Number : 2675

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-702

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Pharmapia Co., Ltd.

    Registration Date : 2021-11-23

    Registration Number : 20210210-210-J-700(1)

    Manufacturer Name : Shilpa Medicare Limited, Unit-1

    Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B , Deosugur Industrial area, Deosugur, Raichur - 584 170, Karnataka, India

     VMF Others AUDIT
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    Market
    Place

    09

    Oxaliplatin

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

    European Pharma Congress
    Not Confirmed
    arrow

    Oxaliplatin

    India

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

    arrow
    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-06-10

    Pay. Date : 2013-09-23

    DMF Number : 23563

    Submission : 2010-02-23

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R1-CEP 2006-201 - Rev 02

    Issue Date : 2022-07-20

    Type : Chemical

    Substance Number : 2017

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0148

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-704

    Start Marketing Date : 2022-08-11

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Shin Poong Pharmaceutical Co., Ltd.

    Registration Date : 2014-04-11

    Registration Number : 20120224-197-I-27-02(1)

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot No: 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosugur-584 170 Dist: Raichur, Karnataka, India

     VMF Others AUDIT
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    Market
    Place

    10

    Pemetrexed Disodium

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

    European Pharma Congress
    Not Confirmed
    arrow

    Pemetrexed Disodium

    India

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

    arrow
    European Pharma Congress
    Not Confirmed
    • fda
    • EDQM
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2013-06-13

    Pay. Date : 2013-02-13

    DMF Number : 25102

    Submission : 2011-09-21

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : R0-CEP 2022-087 - Rev 00

    Issue Date : 2023-07-07

    Type : Chemical

    Substance Number : 3046

    Status : Valid

     JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2019-07-05

    Valid Till : 2022-07-02

    Written Confirmation Number : WC-0147

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 82920-007

    Start Marketing Date : 2022-08-10

    End Marketing Date : 2024-12-31

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

    Marketing Category : BULK INGREDIENT

    KDMF arrow-down
    ✖

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2023-02-13

    Registration Number : No. 2816-4-ND(A)

    Manufacturer Name : Shilpa Pharma Lifesciences Limited

    Manufacturer Address : Plot Nos. 33, 33A, 40 to 47, Raichur Industrial Growth Centre, Wadloor Road, Chicksugur cross, Chicksugur-584 134, Raichur, Karnataka, India

     VMF Others AUDIT
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    USDMF

    read-more
    read-more

    01

    Anastrozole

    India
    Natural Products Expo
    Not Confirmed
    arrow

    02

    Anastrozole Usp

    India
    Natural Products Expo
    Not Confirmed
    arrow

    03

    Axitinib

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Axitinib

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-02-05

    Pay. Date : 2015-12-23

    DMF Number : 30104

    Submission : 2015-12-24

    Status : Active

    Type : II

    blank

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    Web Link

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    Market
    Place

    04

    Azacitidine

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Azacitidine

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-03-15

    Pay. Date : 2013-09-23

    DMF Number : 27487

    Submission : 2013-09-23

    Status : Active

    Type : II

    blank

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    Web Link

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    Market
    Place

    05

    Bendamustine Hcl

    India
    Natural Products Expo
    Not Confirmed
    arrow

    06

    Bicalutamide Usp

    India
    Natural Products Expo
    Not Confirmed
    arrow

    07

    Bortezomib

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Bortezomib

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    GDUFA

    DMF Review : Complete

    Rev. Date : 2022-05-25

    Pay. Date : 2022-05-20

    DMF Number : 36821

    Submission : 2022-03-09

    Status : Active

    Type : II

    blank

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    08

    Bortezomib

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Bortezomib

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-01-31

    Pay. Date : 2013-02-13

    DMF Number : 24944

    Submission : 2011-08-23

    Status : Active

    Type : II

    blank

    Product
    Web Link

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    Market
    Place

    09

    Busulfan Usp

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Busulfan Usp

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    GDUFA

    DMF Review : Complete

    Rev. Date : 2013-07-02

    Pay. Date : 2012-12-19

    DMF Number : 25491

    Submission : 2011-12-07

    Status : Active

    Type : II

    blank

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    Web Link

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    #PipelineProspector

    Market
    Place

    10

    Cabazitaxel

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Cabazitaxel

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    GDUFA

    DMF Review : Complete

    Rev. Date : 2020-07-28

    Pay. Date : 2020-07-02

    DMF Number : 33087

    Submission : 2020-06-30

    Status : Active

    Type : II

    blank

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    Market
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    CEP/COS

    read-more
    read-more

    01

    Ambroxol hydrochloride

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    02

    Buflomedil Hydrochloride

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    03

    Busulfan

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    04

    Capecitabine

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    05

    Carboplatin

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    06

    Cyclophosphamide monohydrate

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    07

    Desmopressin

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    08

    Fingolimod hydrochloride

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    09

    Gemcitabine hydrochloride

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow

    10

    Gemcitabine hydrochloride, Process-2

    CEP/COS

    German Catalysts Meet
    Not Confirmed
    arrow
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    LISTED APIs

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    Abiraterone Acetate

    Product
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    Market
    Place

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
    blank

    01

    Abiraterone Acetate

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Abiraterone Acetate

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

    blank

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    • EDQM
    • WHO-GMP
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    Afatinib

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
    blank

    02

    Afatinib

    India
    Natural Products Expo
    Not Confirmed
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    Afatinib

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
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    • WHO-GMP
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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

    blank

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    Contact Supplier
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    Ambroxol Hydrochloride

    Product
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    #PipelineProspector

    Market
    Place

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
    blank

    03

    Ambroxol Hydrochloride

    India
    Natural Products Expo
    Not Confirmed
    arrow

    Ambroxol Hydrochloride

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Contact Supplier
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    • EDQM
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    • fda
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    Amifampridine

    Product
    Web Link

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    #PipelineProspector

    Market
    Place

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
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    04

    Amifampridine

    India
    Natural Products Expo
    Not Confirmed
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    Amifampridine

    India
    arrow
    Natural Products Expo
    Not Confirmed
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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Axitinib

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    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
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    Axitinib

    India
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    Axitinib

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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Azacitidine

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    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
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    Azacitidine

    India
    Natural Products Expo
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    Azacitidine

    India
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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Bendamustine Hydrochloride

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    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
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    Bendamustine Hydrochloride

    India
    Natural Products Expo
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    Bendamustine Hydrochloride

    India
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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Bicalutamide

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    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
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    Bicalutamide

    India
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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Bortezomib

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    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
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    Bortezomib

    India
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    Bortezomib

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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Busulfan

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    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
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    Busulfan

    India
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    Busulfan

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    Shilpa Medicare

    Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

    About the Company : Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today S...

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    Only 10 entries up to this point, click to access all click full view read-more
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    Drugs in Development

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    Amneal and Shilpa Gain FDA Approval for BORUZU™, Ready-to-Use Bortezomib

    Details:

    Bortezomib injection is a proteasome inhibitor approved for treatment of adult patients with multiple myeloma and adult patients with mantle cell lymphoma.


    Lead Product(s): Bortezomib

    Therapeutic Area: Oncology Brand Name: Boruzu

    Study Phase: ApprovedProduct Type: Small molecule

    Recipient: Amneal Pharmaceuticals

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 05, 2024

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    Shilpa Medicare

    India
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    Shilpa Medicare

    India
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    Lead Product(s) : Bortezomib

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Recipient : Amneal Pharmaceuticals

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Amneal and Shilpa Gain FDA Approval for BORUZU™, Ready-to-Use Bortezomib

    Details : Bortezomib injection is a proteasome inhibitor approved for treatment of adult patients with multiple myeloma and adult patients with mantle cell lymphoma.

    Product Name : Boruzu

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    September 05, 2024

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    Shilpa Medicare Completes Phase 1 Trial of Human Albumin as First in India

    Details:

    sRbumin (recombinant human albumin) is a synthetic form of human serum albumin protein, which is currently being evaluated for the treatment of accidents, burns, and surgeries.


    Lead Product(s): Albumin

    Therapeutic Area: Trauma (Emergency, Injury, Surgery) Brand Name: sRbumin

    Study Phase: Phase IProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable August 28, 2024

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    02

    Shilpa Medicare

    India
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    Shilpa Medicare

    India
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    Lead Product(s) : Albumin

    Therapeutic Area : Trauma (Emergency, Injury, Surgery)

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Shilpa Medicare Completes Phase 1 Trial of Human Albumin as First in India

    Details : sRbumin (recombinant human albumin) is a synthetic form of human serum albumin protein, which is currently being evaluated for the treatment of accidents, burns, and surgeries.

    Product Name : sRbumin

    Product Type : Large molecule

    Upfront Cash : Not Applicable

    August 28, 2024

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    Shilpa Medicare Launches Pemetrexed Injection

    Details:

    Pemrydi (pemetrexed) is the first ready-to-use formulation approved for commercialization in the US market. It is indicated for patients suffering from non-small cell lung cancer.


    Lead Product(s): Pemetrexed

    Therapeutic Area: Oncology Brand Name: Pemrydi RTU

    Study Phase: Approved FDFProduct Type: Cytotoxic Drug

    Recipient: Amneal Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable April 16, 2024

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    03

    Shilpa Medicare

    India
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    Shilpa Medicare

    India
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    Lead Product(s) : Pemetrexed

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Recipient : Amneal Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Shilpa Medicare Launches Pemetrexed Injection

    Details : Pemrydi (pemetrexed) is the first ready-to-use formulation approved for commercialization in the US market. It is indicated for patients suffering from non-small cell lung cancer.

    Product Name : Pemrydi RTU

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    April 16, 2024

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    Shilpa Medicare Gets Europe Approval for Varenicline Tablets, 0.5mg and 1mg

    Details:

    Varenicline is a nAChRα4&β2 (Neuronal acetylcholine receptor; alpha4/beta2) agonist, small molecule drug. It is approved for the treatment of smoking cessation.


    Lead Product(s): Varenicline Tartrate

    Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 26, 2024

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    04

    Shilpa Medicare

    India
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    Shilpa Medicare

    India
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    Lead Product(s) : Varenicline Tartrate

    Therapeutic Area : Psychiatry/Psychology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Shilpa Medicare Gets Europe Approval for Varenicline Tablets, 0.5mg and 1mg

    Details : Varenicline is a nAChRα4&β2 (Neuronal acetylcholine receptor; alpha4/beta2) agonist, small molecule drug. It is approved for the treatment of smoking cessation.

    Product Name : Undisclosed

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    February 26, 2024

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    Shilpa Medicare Launches 'Oraal’ for Treatment of Oral Mucositis

    Details:

    ORAAL, an oral spray with a naturally derived formulation, which is indicated for the treatment of oral mucositis. The composition of ORAAL is protected by a granted patent in India until November 2033.


    Lead Product(s): Curcuma Longa,Glycerine,Propolis

    Therapeutic Area: Immunology Brand Name: Oraal

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 13, 2023

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    05

    Shilpa Medicare

    India
    arrow
    Natural Products Expo
    Not Confirmed

    Shilpa Medicare

    India
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    Natural Products Expo
    Not Confirmed
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    Lead Product(s) : Curcuma Longa,Glycerine,Propolis

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Shilpa Medicare Launches 'Oraal’ for Treatment of Oral Mucositis

    Details : ORAAL, an oral spray with a naturally derived formulation, which is indicated for the treatment of oral mucositis. The composition of ORAAL is protected by a granted patent in India until November 2033.

    Product Name : Oraal

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    October 13, 2023

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    Shilpa Medicare Receives UKMHRA Approval for Mouth-dissolving Strips to Treat Illnesses

    Details:

    Betahistine dihydrochloride is an antivertigo agent, which is act as the histamine receptor inhibitor, which is indicated for the reduction of recurrent vertigo episodes associated with Meniere's disease in patients 18 years old and above.


    Lead Product(s): Betahistine Dihydrochloride

    Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Betahistine Dihydrochloride-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 03, 2023

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    06

    Shilpa Medicare

    India
    arrow
    Natural Products Expo
    Not Confirmed

    Shilpa Medicare

    India
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    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Betahistine Dihydrochloride

    Therapeutic Area : Otolaryngology (Ear, Nose, Throat)

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Shilpa Medicare Receives UKMHRA Approval for Mouth-dissolving Strips to Treat Illnesses

    Details : Betahistine dihydrochloride is an antivertigo agent, which is act as the histamine receptor inhibitor, which is indicated for the reduction of recurrent vertigo episodes associated with Meniere's disease in patients 18 years old and above.

    Product Name : Betahistine Dihydrochloride-Generic

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    September 03, 2023

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    Shilpa Medicare Launches Lenvatinib Capsules in India Under the Brand Name Lenshil

    Details:

    Lenshil (lenvatinib mesylate), an oral receptor tyrosine kinase inhibitor, launched in India, for the treatment of differentiated thyroid cancer, advanced liver cancer and advanced kidney cancer.


    Lead Product(s): Lenvatinib

    Therapeutic Area: Oncology Brand Name: Lenshil

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 30, 2023

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    07

    Shilpa Medicare

    India
    arrow
    Natural Products Expo
    Not Confirmed

    Shilpa Medicare

    India
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    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Lenvatinib

    Therapeutic Area : Oncology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Shilpa Medicare Launches Lenvatinib Capsules in India Under the Brand Name Lenshil

    Details : Lenshil (lenvatinib mesylate), an oral receptor tyrosine kinase inhibitor, launched in India, for the treatment of differentiated thyroid cancer, advanced liver cancer and advanced kidney cancer.

    Product Name : Lenshil

    Product Type : Small molecule

    Upfront Cash : Not Applicable

    June 30, 2023

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    Shilpa Medicare Gets Tentative American Health Regulator Nod for Apremilast Tablets

    Details:

    The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing.


    Lead Product(s): Apremilast

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Approved FDFProduct Type: HPAPI

    Sponsor: Inapplicable

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 05, 2021

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    08

    Shilpa Medicare

    India
    arrow
    Natural Products Expo
    Not Confirmed

    Shilpa Medicare

    India
    arrow
    Natural Products Expo
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Lead Product(s) : Apremilast

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Shilpa Medicare Gets Tentative American Health Regulator Nod for Apremilast Tablets

    Details : The company has received tentative approval from US Food and Drug Administration for its abbreviated new drug application (ANDA) Apremilast tablets in the strengths of 10 mg, 20 mg, and 30 mg, Shilpa Medicare said in a regulatory filing.

    Product Name : Undisclosed

    Product Type : HPAPI

    Upfront Cash : Inapplicable

    March 05, 2021

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    Excipients

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    Contact Shilpa Medicare and get a quotation

    Shilpa Medicare is a supplier offers 74 products (APIs, Excipients or Intermediates).

    Find a price of Busulfan bulk with DMF, CEP, JDMF offered by Shilpa Medicare

    Find a price of Capecitabine bulk with DMF, CEP, JDMF offered by Shilpa Medicare

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    Find a price of Letrozole bulk with DMF, CEP, JDMF offered by Shilpa Medicare

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    Find a price of Bicalutamide bulk with DMF, JDMF offered by Shilpa Medicare

    Find a price of Fingolimod Hydrochloride bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Imatinib Mesylate bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Irinotecan Hydrochloride bulk with DMF, CEP offered by Shilpa Medicare

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    Find a price of Oxaliplatin bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Pemetrexed Disodium bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Pirfenidone bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Tranexamic Acid bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Zoledronic Acid bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Anastrozole bulk with JDMF offered by Shilpa Medicare

    Find a price of Cyclophosphamide bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Gemcitabine bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Teriflunomide bulk with DMF, CEP offered by Shilpa Medicare

    Find a price of Axitinib bulk with DMF offered by Shilpa Medicare

    Find a price of Bendamustine Hydrochloride bulk with DMF offered by Shilpa Medicare

    Find a price of Bortezomib bulk with DMF offered by Shilpa Medicare

    Find a price of Cabazitaxel bulk with DMF offered by Shilpa Medicare

    Find a price of Clofarabine bulk with DMF offered by Shilpa Medicare

    Find a price of Decitabine bulk with DMF offered by Shilpa Medicare

    Find a price of Dimethyl Fumarate bulk with DMF offered by Shilpa Medicare

    Find a price of Enzalutamide bulk with DMF offered by Shilpa Medicare

    Find a price of Erlotinib Hydrochloride bulk with DMF offered by Shilpa Medicare

    Find a price of Imatinib Mesylate bulk with DMF offered by Shilpa Medicare

    Find a price of Lenalidomide bulk with DMF offered by Shilpa Medicare

    Find a price of Melphalan Hydrochloride bulk with DMF offered by Shilpa Medicare

    Find a price of Pomalidomide bulk with DMF offered by Shilpa Medicare

    Find a price of Praziquantel bulk with CEP offered by Shilpa Medicare

    Find a price of Prucalopride Succinate bulk with DMF offered by Shilpa Medicare

    Find a price of Sunitinib bulk with DMF offered by Shilpa Medicare

    Find a price of Anastrozole bulk with DMF offered by Shilpa Medicare

    Find a price of CAS 284461-73-0 bulk with CEP offered by Shilpa Medicare

    Find a price of Desmopressin Acetate bulk with CEP offered by Shilpa Medicare

    Find a price of Eltrombopag bulk with DMF offered by Shilpa Medicare

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    Find a price of Octreotide Acetate bulk with CEP offered by Shilpa Medicare

    Find a price of Pemetrexed Dipotassium bulk with DMF offered by Shilpa Medicare

    Find a price of Phenylephrine Hydrochloride bulk with DMF offered by Shilpa Medicare

    Find a price of Tenofovir Alafenamide Fumarate bulk with DMF offered by Shilpa Medicare

    Find a price of Tranexamic Acid bulk with DMF offered by Shilpa Medicare

    Find a price of Ursodeoxycholic Acid bulk with CEP offered by Shilpa Medicare

    Find a price of Varenicline Tartrate bulk with DMF offered by Shilpa Medicare

    Find a price of Irinotecan hydrochloride trihydrate, Process 2, Form b bulk with CEP offered by Shilpa Medicare

    Find a price of Acebrophylline bulk offered by Shilpa Medicare

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    Find a price of Carboplatin bulk offered by Shilpa Medicare

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    Find a price of Sorafenib bulk offered by Shilpa Medicare

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    Find a price of Abiraterone Acetate bulk offered by Shilpa Medicare

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    Find a price of Pazopanib Hydrochloride bulk offered by Shilpa Medicare

    Find a price of Selexipag bulk offered by Shilpa Medicare

    Find a price of Tenofovir Alafenamide bulk offered by Shilpa Medicare

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