sun pharma annual report 2015 16

OGD issues product-specific recommendations (or “bioequivalence guidances”) to facilitate efficient filing review, pre-market development of generic drug products, and accurate tracking of OGD’s activities in this area. We are confident in OGD’s ability to meet our GDUFA goals. Deployed the largest amount of spectrum for 4G in india, Major products & brands across energy & service sectors, RIL’s Petroleum Retail network outlets currently operational, Retail stores currently operating across india. A Case for Shareholders' Fiduciary Duties in Common Law Asia With our ongoing efforts–and strong public input–we are confident that 2016 and beyond will be as successful as 2015. Found inside – Page 270Sun Pharmaceuticals is also practicing technology enabled performance management system known as PRIDE which is six ... of the department and performance- based rewards are also enjoyed by the employees (Torrent Annual Report, 2016). Annual Reports - Pharmaceutical Manufacturing and Exports ... GDUFA requires FDA, specifically OGD and the other offices involved in generic drug review activities, to conduct reviews of generic applications in a timely way. sees remediation process at erstwhile Ranbaxy facilities as a "time consuming" process even as it aims to bring at least one of the plants to conform to current good manufacturing practice regulations (cGMP) in the current fiscal. It is classified as a public limited company and is located in Hyderabad, Telangana. Annual Reports Presentations | Sun Pharmaceutical ... Found inside – Page 287Sun Pharmaceutical Industries. 2016. Annual Report 2015–16. Mumbai: Sun Pharmaceutical Industries. Sundet, Geir, and Eli Moen. 2009. Political economy analysis of Kenya (NORAD Report 19/2009 Discussion Paper). OGD prioritizes guidance development based on a number of factors, including the timing of the date one year prior to expiration of marketing exclusivity (known as NCE-1). OGD issued 1,278 Complete Responses, or written letters to applicants identifying deficiencies that applicants need to resolve before approval of an ANDA. In March 2015, we completed the merger of Ranbaxy with Sun Pharma. While the growth in advanced economies increased moderately, the Emerging Market and Developing . When deficiencies are identified, industry usually responds by correcting them through an amendment to the application. 2015: 59bn Market shareFlat Rothmans Rothmans is an iconic brand established in London in 1890. This research supports the development of guidance and policy that clarifies the ANDA pathway for complex products, such as drug-device combinations, transdermal systems, implants and parenteral microspheres, nanomaterials (e.g. Torrent Pharma France S.A.S. Invigorating India through insightful innovations and strategic investments, Reliance with a select few, has been an architect of the country’s growth trajectory. Annexure to Board's Report 2020 Annexure to Board's Report 2019 Annexure to Board's Report 2018 Annexure to Board's Report 2017 Annexure to Board's Report 2016. Annual Report 2017-18 Download. ORO provides oversight across all review disciplines to ensure that all generic drug review and decision-making activities are well-documented and follow a clearly defined, rigorous, scientific, and regulatory review process. Serves as OGD liaison to CDER’s Office of Surveillance and Epidemiology (OSE) and other drug surveillance organizations within CDER. Vardhman group of companies is a major integrated textile producer in India. Due to the significant expansion of the generic drug industry and corresponding increase in ANDA submissions, FDA adapted its systems and processes to continue to meet its scientific, GDUFA and other program goals. Freedom in the World, the Freedom House flagship survey whose findings have been published annually since 1972, is the standard-setting comparative assessment of global political rights and civil liberties. In 2014, OGD enacted a critical improvement to the ANDA review process - assigning a regulatory project manager (RPM) to each ANDA. The results from BE studies in patients were completely consistent with the healthy subject BE studies used for original approval. We are India’s largest commercial bank in terms of assets, deposits, branches, number of customers and employees and enjoy the continuing faith of millions of customers across the social spectrum. Q1 April - June Download. Additional GDUFA hires were distributed across the many CDER and FDA offices involved in the generic drug program. GDUFA metrics ramp up over time and ultimately result in a 10-month GDUFA goal for all original ANDAs. Annual Reports for 2020-2021. 4. Annual Report (Archive) 16.64% 17.39% 18.42% 16.89% 16.11% Current Account (` in billion) Savings Account (` in billion) March 2016 March 2017 March 2018 March 2019 March 2020 Intimation for Concall with Investor / Analysts Q4_2019-20. Reliance also continues to cater to its consumers’ diverse needs through over 150 major products and brands across energy and service sectors. Invest Now. To fully realise this potential, much work needs to be done by a wide range of stakeholders. OGD hired approximately 125 new employees in 2015 to achieve GDUFA mandates to hire additional staff to support the growing generic drug program. Volume73bn +36.9% 2015: 52bn Market share+70 bps 02 British American Tobacco Annual Report 2016 . Details on the significant external and internal regulations and policies that affect corporate governance, is specified in our Annual Report 2020. Because of the amount of hiring, restructuring and catch-up needed, performance goals were set to commence in the later years of the program. Since its inception, Reliance has partnered the nation to develop and grow into its full potential and propel the India growth story forward. * Numbers reflect data available at the time of report publication and may change based on refreshed counts in our tracking systems, including application status updates. This report takes a broad view of the link between work and human development. 2016-17. Torrent is completely focused towards the goal of value enhancement for its investors. Glenmark Pharmaceuticals (Australia) Pty Ltd. Glenmark Pharmaceuticals Kenya Ltd. Glenmark Pharmaceuticals Malaysia Sdn Bhd. These basic principles are applicable to most cultures. This book is a must for managers and students, and offers general information to all who wish to expand their knowledge of people to people interaction. This book features a convergence of healthcare professionals and scholars providing insights into the best practices of interventions and reform as well as practical applications to foster patient engagement and participation. With the human dosing underway, we hope that our quest to provide a safe and efficacious vaccine to prevent COVID-19 is a fruitful one. This total includes 99 approvals and tentative approvals in December, the most approvals and tentative approvals granted in a single month since the start of the generic drug program. The Works of William Perkins fills a major gap in Reformed and Puritan theology. Though Perkins is best known today for his writings on predestination, he also wrote prolifically on many subjects. View PDF. . These investigations provide additional data in therapeutic areas where concerns exist about the substitutability of generic drugs and allow FDA to verify if generic drugs are fully interchangeable, safe and effective in comparison to their RLD. Ranks 238th in the Financial Times’ FT Global 500 2015 list of the world’s largest companies. The meeting provided an overview of the current status of the regulatory science initiatives for generic drugs and provided an opportunity for the public input on research priorities in these topic areas. This book is an extraordinary story of an ordinary man, who chooses to stay anti-famous. He would rather have his face unrecognized, his story untold. Form MGT-9. Subsidiary 1. In August 2014, there were more than 1,100 applications that had not been reviewed for an initial filing decision. 1FY 15-16 includes one-time profit share of around H1050 crs Macquarie Research 8 Jul 2015. Backlog applications are defined as pre-GDUFA applications pending before the Agency on October 1, 2012; FDA’s first action on these applications is required by the end of Fiscal Year 2017. Program Management and Analysis Staff (PMAS) - Provides leadership, guidance and support services to OGD on all aspects of budget, contracts, facilities management, human resources, personnel operations services, scientific fellowships and recruitment activities. Members are requested to bring their copies to the meeting. In keeping with our commitment to promote quality science and clinical relevance, updates on our work in progress can be found in more than one hundred published scholarly articles, presentations, posters and book chapters. Intimation for Presentation to analysts on audited financial result for the quarter and year ended 31st March, 2021. Stock Exchange intimation of 46th AGM. Financial Statements of Subsidiaries FY 2020-21. Among other accomplishments, 2015 marked the highest number of generic drug approvals and tentative approvals ever–more than 700. within the timeframes listed; it does not mean FDA should approve applications, etc. Today there is no backlog, and filing is performed in real time. Reliance Retail’s nationwide network of retail outlets delivers a world-class shopping environment and unmatched customer experience powered by state-of-the-art technology and seamless supply-chain infrastructure. Annual Report. Annual Report 2017-18. 10 Dec 15. Credit Suisse 10 Dec 2015. Investors Grievances. The IO provides oversight, leadership, strategic direction and support for OGD and its four sub-offices. FDA continues to prioritize research for abuse-deterrent formulations, narrow therapeutic index (NTI) drugs and equivalence of modified-release solid oral dosage forms. In the company's Annual Report for 2015-16, Sun Pharma Managing Director Dilip Shanghvi also remained bullish on generating targeted synergies of $300 million by . Sun Pharmaceutical Industries Limited (d/b/a Sun Pharma) is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States.Sun Pharma has presence in more than 100 countries across the globe. Annual Report 2018-19 1 SPECIALTY IN PROGRESS We, at Sun Pharma, view our specialty business as an additional engine of sustainable growth and cashflows over the long term. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. In November 2015, they sent a warning letter to your Company. Annual Report 2012-13 Download. It illustrates the central corporate bodies during 2021. Self Declaration Format for Non-Resident Shareholders. Track your portfolio 24X7. Chapter 1. Annual Report 2016-17. Annual Report. Title. Annual Return MGT-9. As a result, FDA’s generic drug program became increasingly under-resourced. Intimation to Stock Exchange. Consolidated Financial Results. Reliance started a transformative force with a view to digitally empower and enrich Indians with a distinctly digital identity of their very own. ORS leads in the development of scientific standards for generic drugs, establishes predictive and physiological models of drug product performance, drug absorption, drug pharmacology and other quantitative methods for ensuring generic drug equivalence and develops new tools for analyzing in vitro pharmacokinetic, pharmacodynamic and clinical BE studies. Generic drugs make up nearly 88 percent of prescriptions filled in the United States and represent affordable access to treatment for many patients and consumers. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA” (general ANDA guidance) explains broader principles that apply to the majority of products and product-specific bioequivalence (BE) guidances are tailored to a specific drug development program and takes into account the unique features of the drug. We are streamlining OGD’s review processes to expedite thorough review of pending abbreviated new drug applications (ANDAs) and cutting the average review time. About Cipla Established in 1935, Cipla is a global pharmaceutical company focused on responsible and sustainable growth through deep & wide portfolio and strong customer relationships across . Annexure to Board's Report 2020 Annexure to Board's Report 2019 Annexure to Board's Report 2018 Annexure to Board's Report 2017 Annexure to Board's Report 2016. within such timeframes.+If no input required from clinical division*10 months if inspection required^4 months~10 months. Unaudited Financial Results for the quarter 31 st December, 2020. Equivalence of locally acting products - research into new bioequivalence methods and pathways for locally acting drugs (such as inhalation, topical dermatological, nasal, ophthalmic, gastrointestinal and otic drug products). Seventh Annual Edition: 2015, available at: www.gphaonline.org/media/wysiwyg/PDF/GPhA_Savings_Report_2015.pdf. RIL is India’s largest private sector company on key financial parameters. Q3 October - December Download. Scrutinizers Report - Annual general Meeting held on November 16, 2017 Scrutinizers Report - Annual General Meeting held on December 2, 2016 Scrutinizers Report - Annual General Meeting held on October 28, 2015 Scrutinizers Report for E-voting - Annual General Meeting held on September 24, 2014 " -Global Trends 2040 (2021) Global Trends 2040-A More Contested World (2021), released by the US National Intelligence Council, is the latest report in its series of reports starting in 1997 about megatrends and the world's future. In June 2015, OGD held the third annual public hearing on GDUFA regulatory science priorities. Annual Report 2019-20 Integrated Report Statutory Reports Financial Statements 2 3. 1: Communications with Industry with Respect to Pre-GDUFA Year Three Abbreviated New Drug Applications, MAPP 5241.2: Consolidation of ANDAs by the Office of Generic Drugs, MAPP 5200.7: Review of ANDA Amendments and Supplements by the Division of Filing Review, Enhancing Communication with Industry and Stakeholders, Regulatory Education for Industry (REdI) Generic Drugs Forum, Guidance for Industry: Controlled Correspondence Related to Generic Drug Development, Appendix: Notable First-Time Generic Drug Approvals, List of all first generic drugs approved in 2015, Office of Generic Drugs (OGD) Annual Report for 2016. The book brings together nearly 300 diverse works— including sculpture, relief decoration, stelae, jewelry, coffins, funerary objects, and personal possessions from the world’s leading collections of Egyptian art. One example of an in vitro alternative is that for a generic product that is qualitatively (Q1) and quantitatively (Q2) similar in ingredients to its reference product, an ANDA applicant could use a set of comprehensive laboratory characterization test to demonstrate that there is no significant difference between their product and the reference (Q3 equivalence). Annual Report 2015-16 SUN PHARMACEUTICAL INDUSTRIES LTD. As the world's fifth largest specialty generic pharmaceutical enterprise and India's leading pharmaceutical company, we are leveraging the advantages of deeper integration and economies of scale globally. ORS consists of an Immediate Office, a Division of Therapeutic Performance and a Division of Quantitative Methods and Modeling. Annual Report 2020-21 (Single Page) Annual Report 2020-21 (Double Page) Annual Return 2020-21. Buy Sun Pharmaceutical Industries; target of Rs 965: ICICI Direct 03.11.2021 Sun Pharma Standalone September 2021 Net Sales at Rs 4,143.15 crore, up 25.84% Y-o-Y Serves as liaison to CDER’s Office of Communications and FDA’s Office of Media Affairs. Newspaper Notice of 46th AGM and E-voting Procedure. In the company's annual report for 2015-16, Sun Pharma managing director Dilip Shanghvi also remained bullish on generating targeted synergies of $300 million by next fiscal on account of its . GDUFA research funding for new and continuing awards was distributed across the GDUFA regulatory science priority areas: 1. Alembic Pharmaceuticals Limited - Annual Report - 2015-16. As of October 1, 2012, the backlog included 2,866 ANDAs and 1,873 PASs. Overall, ORO responds to more than 50,000 submissions a year. Annual Reports - Pharmaceutical Manufacturing and Exports, Research and Development in Pharma. The revised draft product-specific BE recommendations take into account careful examination of emerging postmarket reports of adverse events, analysis of new studies and review of relevant literature. Read more about Annual Report FY 2012-13; Annual Report FY 2011-12. Torrent Pharma France S.A.S. Reliance’s businesses and operations have a deep and wide impact across Indian society. Profit and Loss. ESOP Disclosure Pursuant to SEBI Regulations. Coordinates and supports OGD’s global engagement activities in collaboration with internal and external stakeholders. A timeless classic with high-quality standards, Rothmans is fi nding increasing appeal among adult smokers worldwide thanks to a contemporary proposition. These pioneering efforts demonstrate Reliance’s unwavering faith in the nation’s potential and purpose. ORO reconfigured employee orientation to complement discipline-based classroom training, online instruction and on-the-job activities. Reliance is one of the largest exploration and production players in India. Annual Report 2015-16 SUN PHARMACEUTICAL INDUSTRIES LTD. As the world's fifth largest specialty generic pharmaceutical enterprise and India's leading pharmaceutical company, we are leveraging the advantages of deeper integration and economies of scale globally. Marg., New Marine Lines, Mumbai 400020, at 3:30pm. OGDP represents OGD on policy issues, provides direction in the development and implementation of statements of policy related to generic drugs and maintains the “Approved Drug Products with Therapeutic Equivalence Evaluations” publication (also known as the “Orange Book”). 16th AGM Voting Outcome. Tech Mahindra Annual Reports, Impact Assessment Reports, and Research Reports Details of the achievements and initiatives taken by your Bank are provided in the enclosed Annual Report for the year 2015-16. The year 2015 was another difficult year for the global economy, with economic growth easing to 3.1% as per IMF estimates. All OGD project managers underwent in-depth communication and customer engagement training as part of FDA’s focus on increased and improved communication with industry. Due to this, it was observed that Sun Pharma had violated regulation 23(2), 23(4) and 34(3) of SEBI (LODR . Read more about Annual Report FY 2014-15; Annual Report FY 2013-14. 12.5 mg and 25 mg. Sun Pharma Global FZE. Aptil Pharma Limited. Our global presence is Over the last several decades, the generic industry, the number of abbreviated new drug applications, or “ANDAs,” submitted to FDA for review and the number of foreign facilities making generic drugs all grew substantially. Annual Report. This issue discusses a number of factors affecting global growth, as well as growth prospects across the world’s main countries and regions. Annual Report 2015-16. Despite persisting global economic uncertainty, we have delivered the best operating and financial performance in our history. Employee Cost Summary and Revenue Expenditure on Social Overheads Download. An important reference for researchers in the pharmaceutical industry, environmentalists and policy makers wanting to better understand the impacts of pharmaceuticals on the environment. Offering a taxonomy of emerging market innovations, this collection reveals the unique drivers, types, and outcomes of innovation in emerging markets. OB consists of an Immediate Office, three Divisions of Bioequivalence and a Division of Clinical Review. MC30 is a curated basket of 30 investment-worthy OGD’s MAPPs define our policy, mission and goals as they relate to generic drugs. Vardhman portfolio includes manufacturing and marketing of Yarns, Fabrics, Sewing Threads, Fibre and Alloy Steel. Annual Report 2019-20 Download. OGDP consists of an Immediate Office, the Division of Legal and Regulatory Support and the Division of Policy Development. Annual Reports. Workload Summary Pre-FY2015 GDUFA Controls (submitted prior to 10/2014). In exchange, FDA committed to performance goals, the specifics of which are contained in the Generic Drug User Fee Act Program Performance Goals and Procedures agreement that was negotiated with industry (“GDUFA Commitment Letter”). In India, is specified in our stakeholder and public meetings grow into its full potential and propel the growth. Generic company online instruction and on-the-job activities, there were more than 50,000 submissions a.. Future PLANS & amp ; STRATEGY the company is adding Valsartan to its hypertension portfolio, which will.... Ogd issued 1,278 Complete Responses, or written letters to applicants identifying deficiencies applicants. November 2015, ending with December ’ s largest private sector company on key parameters... 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