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patent system by the pharmaceutical industry, moves by some drugmakers to expand their patent claims appear to be delaying the arrival of lower-cost genericmedicines to the marketplace, according to a STAT analysis. Amid debate over potential abuse of the U.S.
Union Minister of Chemicals and Fertilizers, and Health and Family Welfare, Jagat Prakash Nadda inaugurated the weeklong celebrations of Jan Aushadhi Diwas, 2025 by flagging off the Rath (Chariot) and 10 other vehicles carrying the information about Pradhan Mantri Bhartiya Janaushadhi Pariyojana from Nirman Bhawan.
The Drug Master File (DMF) has all the information on an API (Active Pharmaceutical Ingredient/Raw material for medicine) Mankind Pharma has introduced 120 DMF (Drug Master File) Quality Medicines in the Indian market. This initiative aims to ensure universal access to medicines of international calibre.
The results have informed Teva’s future strategy, in terms of ensuring it has a strong manufacturing network within Europe, said Daniell. We certainly have a problem with national-level procurement policies that put almost no value on genericmedicines … that approach needs to change.
The diversity of thought and experience is remarkable, and I leave every meeting with new learnings and valuable information to take back to my colleagues at USP. This type of proactive and informed approach can aid both in the prevention of drug shortages and mitigation of the impact of those that do occur.
Four new medicines recommended for approval The CHMP recommended granting a marketing authorisation for Sotyktu (deucravacitinib) for the treatment of moderate to severe plaque psoriasis in adults. This product was designated as an orphan medicine during its development.
The group is continuously gathering information from Member States and industry associations to identify signals of availability issues as early as possible.” Larger questions remain around the way in which to support manufacturers to invest in production capabilities for antibiotics.
India Pharma Inc, hailed for its prowess in the production of high-quality genericmedicines, now needs to shift from a conventional, volume-based business strategy to a value-based approach to keep it up its growth momentum. In this context, finding the right opportunities and understanding the challenges has become crucial.
As early as 1968, the first edition of Drug Index for Malaysia & Singapore (DIMS) was published. Core Features Apart from being a source of product leaflet , MIMS also provides some very useful resources. The app was released on both the Google Play Store and Apple App Store for public download. External Links MIMS Malaysia MIMS CPD
The pundits are unanimous in their response – changes in the US generic drug market. The US is the biggest market for genericmedicines (~90 per cent of prescriptions are fulfilled by generic drugs). Ensure full kit: Preparatory work for a new project (material, information, etc.)
In recent years, first generics have improved patient access to essential treatments and offered affordable treatment options for patients with multiple sclerosis, asthma, heart disease, diabetes, and even the flu.
Mr. Shailesh Kapadia spearheaded the discussion on international pharmaceutical marketing, underlining the importance of clear information regarding career prospects in this field. With over 18 years of experience, Mr. Kapadia shared insights into various international business models and strategies for marketing generic and branded drugs.
Nonetheless, still, he said, the industry is doing little to access the necessary information for a post-treatment patient-first approach. Talking through their genericmedicines, of which the company has more than 1,000 projects ongoing, Schultz noted that more than half of the leading medicines on the WHO’s list of medicines are Teva’s.
The aim is to provide evidence to inform public investment and policy reforms that build medicines supply chain resilience and reduce the potential for disruptions. Powered by more than 250 million data points spanning 92% of genericmedicines approved in the U.S.,
Joy Polefrone, the executive director of the organization, says it aims to build a cluster of partners who are capable of manufacturing genericmedicines. The US Department of Commerce’s Economic Development Administration (EDA) awarded the organization $52.9 million as part of the Build Back Better Regional Challenge.
Identification of upstream medicines supply chain risks can enable regulatory and industry action to reduce potential disruptions and shortages by informing risk mitigation strategies, public and private investment, as well as policy reforms that build more resilience, Bray and other panelists suggested.
These amendments are intended to lower the prices of patented medicines in Canada. Medicines that do not fall into one of the three groups of existing patented medicines will be regulated as new patented medicines and assigned to either Category I or Category II. The consultation: next steps.
Analysis leveraging USP’s Medicine Supply Map suggests many of the essential cancer medicines have inherently vulnerable supply chains and are at greater risk for shortage compared to other genericmedicines. The closer the risk score is to 100%, the greater the risk for that drug to be in shortage in the next 12 months.
While reflecting the positive impacts of USP focus areas, in many cases these efforts also will facilitate data collection, target setting, and information sharing that can help USP stakeholders meet their own ESG goals. These USP documentary standards are recognized in U.S.
For example, while some stakeholders may perceive PCM to be primarily for innovators and not for makers of genericmedicines or biotech companies, it “can be for generic companies, biotechnology companies, and so on, and we have had engagements with generic drug companies in our emerging technologies program already,” Fisher said. “I
Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. FDA categories as complex products and/or of guidelines for development and approval of their generic versions.
Explaining the situation, Dr Farhat Mantoo, Executive Director, MSF South Asia informed that MSF has appealed to the Indian government through a letter to the Prime Minister to continue rightfully rejecting the inclusion of intellectual property provisions in the EFTA negotiations that are harmful for access to affordable medicines from India.
Integrating ESG considerations into core pharma operations India, known as the “Pharmacy of the World,” produces over 20 per cent of the global supply of genericmedicines and plays a vital role in vaccine production, as per the Investindia.gov.in It meets the healthcare needs of over 1.4
Pharma services have witnessed extensive innovation from contract development and manufacturing organisation (CDMO), contract research organisation, pharma information technology (Pharma IT). The ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ (9) promotes retail outlets to provide quality genericmedicines at affordable prices.
The deductions work as follows: Branded Medicines (Part VIIIA Category C) : 5% discount GenericMedicines (Part VIIIA Categories A and M) : 20% discount Appliances (Part IX) : 9.85% discount Understanding these deductions is critical, especially when many medicines are unavailable at or below the Drug Tariff price.
Pharma services have witnessed extensive innovation from contract development and manufacturing organisation (CDMO), contract research organisation, pharma information technology (Pharma IT). The ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana’ (9) promotes retail outlets to provide quality genericmedicines at affordable prices.
A genericmedicine, Diethyl fumarate Accord (dimethyl fumarate), received a positive opinion for the treatment of multiple sclerosis (MS), a chronic disease affecting the central nervous system. This rare genetic disorder causes muscle weakness and is often fatal.
This urgency drove USP and the American Cancer Society Cancer Action Network (ACS CAN) to combine our expertise and insights to develop a set of principles, informed by feedback from a range of healthcare stakeholders, to support a comprehensive and coordinated response to U.S. drug shortages.
Innovative business models Beyond innovation in manufacturing, innovative business models also can provide potential solutions to medicines supply chain vulnerabilities, as evidenced by Civica. The non-profit maker of essential genericmedicines was established by a group of U.S. Coukell observed.
Biosimilar medicine Ximluci (ranibizumab) for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease, causing gradual vision impairment, mainly in the elderly population. 11 medicines for indication extension.
This move unburdened the private pharma companies allowing them to concentrate and strengthen their base, and they succeeded in gaining a national as well as international market presence as “global genericmedicine manufacturers.” Rating BX: Awarded to generic products presumed to be therapeutically non-equivalent.
This collaboration also helps inform how USP tackles real-world quality challenges and advocates for strengthening patient access to quality medicine. Convention Sectors convene Members around areas key to USPs work such as biologics, innovation, and genericmedicines to collaborate on these focused topics.
Additionally, the CHMP recommended the genericmedicine Eltrombopag Accord (eltrombopag) to treat primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C. The drug was indicated as a treatment for certain patients with mild cognitive impairment or dementia due to Alzheimers disease.
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