Generic Pharmaceuticals Research Articles

Development of a Stable Lyophilized Cyclophosphamide Monohydrate Formulation Using Non-Aqueous Solvents.

To ensure product stability, it is critical to maintain the monohydrate state of cyclophosphamide following lyophilization, as this is the most stable solid form of the Cyclophosphamide. On the other hand, because of their limited aqueous solubility and stability, non-aqueous solvents are preferred for determining the composition and stability of bulk solutions. Hence, the purpose of this study was to use non-aqueous solvents for determining the composition and stability of bulk solutions, and to shorten the lyophilization process by retaining the cyclophosphamide monohydrate. Furthermore, prior to selecting the solvent for the bulk solution consisting of 90:10 tertiary butyl alcohol (TBA) and acetonitrile (ACN), various factors were taken into account, including the freezing point, vapor pressure of solvents, solubility, and stability of cyclophosphamide monohydrate. The concentration of the bulk solution was adjusted to 200mg/mL in order to optimize the fill volume, enhance sublimation rates at lower temperatures during primary drying, and eliminate the need for secondary drying. The differential scanning calorimetry (DSC) measurements of bulk solution were used to improve the lyophilization cycle. The lyophilization cycle opted was freezing at a temperature of -55°C with annealing step at -22°C by which the reconstitution time was significantly reduced. The drying was performed at below - 25°C while maintaining a chamber pressure of 300 mTorr. The complete removal of non-aqueous solvents was achieved by retaining water within the system. The presence of cyclophosphamide monohydrate was confirmed using X-ray diffraction (XRD). The reduction of lyophilization process time was established by conducting mass transfer tests and evaluating the physicochemical properties of the pharmaceutical product. Using non-aqueous solvents for freeze-drying cyclophosphamide is a viable option, and this study provides significant knowledge for the advancement of future generic pharmaceuticals.

GENERIC DRUG REGISTRATION AND COUNTRY-SPECIFIC REQUIREMENTS IN SAUDI ARABIA, QATAR, BAHRAIN, AND OMAN

Objective: This research aims to examine the regulatory framework and prerequisites for generic drug registration in the Middle East and North Africa (MENA) region, with a specific focus on the countries that make up the Gulf Cooperation Council (GCC). This will enable a deeper understanding of the procedures, records, schedules, and discrepancies related to registration. Methods: The study makes use of an extensive examination of the rules, regulations, and practices about the registration of generic drugs in the MENA. Official government sites, regulatory agencies, and respectable trade journals for the pharmaceutical sector were used as sources of information. The main procedures for registering generic drugs were explained and inspected, encompassing the submission of documents, dossier preparation, bioavailability/bioequivalence tests, and application filing. Results: There are substantial growth prospects for generics. Research highlights the sequential registration process for generic drugs, submitting documents electronically using the Common Technical Document (eCTD) method. For registration to be successful, specific records and data such as bioavailability/bioequivalence research data must be provided. Conclusion: The effective registration of generic medications in the MENA region, especially in the GCC nations, depends on understanding and abiding by nation-specific regulatory standards. The research offers a tactical guide that outlines the essential procedures, paperwork needs, and regional variances in the generic medicine registration process. The goal is to offer affordable healthcare solutions by navigating the regulatory landscape meticulously and streamlining the approval and market entry process for generic pharmaceuticals in the MENA region.

Overview and Lifecycle Management of Generic Pharmaceutical Drugs in Mexico, Guatemala and Brazil

Objective: The generic pharmaceutical markets in Mexico, Guatemala, and Brazil are influenced by distinct regulatory frameworks, production and distribution dynamics, and marketing strategies, which shape lifecycle management. Regulatory policies, market competition, and healthcare initiatives impact accessibility, affordability, and quality, presenting both challenges and opportunities for enhancement in these areas. Summary: This thesis offers an in-depth examination of lifecycle management strategies in the generic pharmaceutical markets of Mexico, Guatemala, and Brazil. Generic drugs are crucial for increasing access to affordable healthcare, especially in emerging economies. Through comparative analysis, this research explores the regulatory frameworks, market dynamics, and key challenges in the development, approval, marketing, and post-marketing surveillance of generic drugs in these three Latin American countries. The study starts with an overview of the regulatory landscape for generic pharmaceuticals in Mexico, Guatemala, and Brazil, highlighting similarities and differences in registration requirements, approval processes, and post-approval obligations. It investigates the roles of regulatory agencies like COFEPRIS, DIGEMID, and ANVISA in ensuring the quality, safety, and efficacy of generic drugs throughout their lifecycle. Additionally, the research delves into the strategies used by pharmaceutical companies for lifecycle management of generic drugs, including variations, biowaivers, and labeling changes. Real-world case studies illustrate post-approval changes and their regulatory implications in each country, providing insights into the complexities of managing generic drug portfolios in different regulatory environments. The thesis also examines the market dynamics affecting the availability, pricing, and accessibility of generic drugs in Mexico, Guatemala, and Brazil. Factors such as patent expirations, competition, healthcare policies, and public procurement practices are analysed to understand their impact on market entry, competition, and the affordability of generic drugs. Furthermore, the study addresses the challenges and opportunities in pharmacovigilance and post-marketing surveillance of generic drugs, emphasizing the need for robust systems to detect and manage adverse drug reactions and ensure patient safety. Conclusion: The key findings highlight regulatory frameworks, market dynamics, and lifecycle management strategies in the generic pharmaceutical markets, identifying challenges and opportunities. The study reflects on implications for stakeholders and suggests areas for future research to enhance accessibility, affordability, and quality.

Analysis of Factors Related to Variation in Dissolution Profiles Estimated from Continuously Conducted Dissolution Tests of Generic Products.

The development of generic pharmaceuticals involves a bioequivalence study to ensure the therapeutic equivalence of the test formulation to the original innovative product. The formulation characteristics of generic products are expected to be maintained in the long term after approval. This study analyzed the factors contributing to the changes in the dissolution profiles of approved products during their life cycles. Cumulative data on the dissolution similarity of 1675 products of 127 ingredients tested by official laboratories in Japan were assessed according to Japanese bioequivalence guidelines with slight modifications. The products showing dissimilarities in dissolution profiles were analyzed for reporting year, therapeutic category, co-development, physical properties of the active pharmaceutical ingredient (API), and suspected reasons for dissolution change. The increase in the number of dissimilar products is related to the co-development of generic products. Although the solubility of the API was not associated with the dissolution change in the analysis of the total dissolution data, control of the API particle size is suggested to be important for drugs with poorly soluble APIs. Additionally, a risk factor for dissolution changes in the test solutions at a certain pH was the presence of acidic or basic residues. These results indicate the importance of proper development through a thorough evaluation of the formulation and process factors affecting the dissolution properties throughout the product lifecycle.

Innovations in Advanced Wound Care from India

India is undergoing significant development in medical device manufacturing, driven by strong government support throughout the conceptualization, inception, and development stages. This growth has been fuelled by initiatives like “Make in India” and the vision of an “AtmaNirbhar Bharat” (self-reliant India), which have provided impetus to the industry. With the integration of AI and machine learning technologies, India has made remarkable progress in the development of domestically manufactured robotic surgery systems. These advanced systems have revolutionized surgical procedures by enhancing precision, efficiency, and accessibility. By leveraging 3D printing technology, India has also made significant strides in producing customized medical devices, prosthetics, and anatomical models. These innovations have facilitated surgical planning and training and contributed to the overall advancement of healthcare in the country. The growth of the medical device industry in India is particularly evident in the class I devices segment. Numerous Indian companies have experienced rapid expansion and have even ventured into foreign markets. This trend is exemplified by the success of hemostatic dressings and wound care devices, where Indian manufacturers have developed high-quality products that have gained recognition globally. While India was traditionally known as the “global pharmacy” for its production of generic pharmaceuticals, it is now making its mark in the medical devices industry by offering innovative and reliable devices on the global stage. The government’s unwavering support and the emphasis on self-reliance have fostered a favorable environment for the growth of India’s medical device manufacturing sector.

Regulatory Guidelines and Production Planning Strategies for Biosimilars in the USA

At present, biosimilar projects are ruling the pharma market. This article aims to show that project management is crucialin developing biosimilars. Bad project management will give a bad reputation to the organization, project cost overruns, projectschedule delays, demotivation of the project team, sustainability risk to the organization, and more over huge loss. It is the main reasonmost companies are spending more on the training of employees, particularly on project management. Biosimilars are biologicalproducts that are highly similar to a reference product despite modest changes in therapeutically inactive components. Biosimilarshave no clinically significant changes in product safety, purity, or potency compared to the reference product. With the imminentpatent expiration of certain important high-cost biologics, biosimilar manufacture is becoming increasingly profitable for firms.However, the introduction of biosimilars necessitates the adoption of critical new rules. Because of the inherent differences involvedwith the production methods used by different companies and even different sites within the same company, the existing standardsthat regulate the approval pathways for generic pharmaceuticals are insufficient for biosimilars. Biosimilars are similar to but notidentical to the original. Due to the exclusive nature of the manufacturing line and the techniques employed by these competitors,basic variances in methodology may exist between competing organizations. Even modest variations in the manufacturing process canresult in micro heterogeneity, characterized by minor differences in molecular structure, stability, production cell line behavior, growthconditions, vectors, and purification methods. For these reasons, developing biosimilars takes a lot of work.1 CBER regulatesbiosimilars in the US Market. The reference Medicine's Patent status and market potential should be considered when developingbiosimilars. The main objective of this article is to show that the project management strategies and regulatory approval process areequally important to enter biosimilars into the market. Concerning quality in the project management of biosimilar products, budget,deadlines, and scopes are major constraints. A Gantt chart has been enacted to represent a graphical illustration of a schedule. Ganttchart helps to plan, coordinate, and track specific tasks in a project.

Generic cardiology drug prices: the potential benefits of the Marc Cuban cost plus drug company model.

Introduction: Generic pharmaceuticals account for the majority of the $359 billion US pharmaceutical market, including for cardiology drugs. Amidst a lack of price transparency and administrative inefficiencies, generic drug prices are high, causing an undue burden on patients. Methods: We identified the 50 most used generic cardiology drugs by volume per the 2020 Medicare Part D spending data. We extracted cost per dose of each drug from the Marc Cuban Cost Plus Drug Company (MCCPDC) website and estimated the aggregate cost savings if MCCPDC were employed on a national scale by calculating the difference between this cost and Medicare spending. Results: Medicare spent $7.7 billion on the 50 most used generic cardiology drugs by volume in 2020 according to Medicare Part D data. Pharmacy and shipping costs accounted for a substantial portion of expenditures. Per our most conservative estimate, $1.3 billion (17% of total) savings were available on 16 of 50 drugs. A slightly less conservative estimate suggested $2.9 billion (38%) savings for 35 of 50 drugs. Discussion: There is enormous potential for cost savings in the US market for generic cardiology drugs. By encouraging increased competition, decreasing administrative costs, and advocating for our patients to compare prices between the MCCPDC and other generic pharmaceutical dispensers, we have the potential to improve access to care and corresponding outcomes for cardiology patients.

Perception Towards Generic and Branded Medicines and its Impact on the Acceptability of Generic Medicines: An Empirical Study among Indian Youth

In many areas of the world, the idea of a generic prescription is commonly accepted. However, it has yet to be successful in gaining popularity in India because of product quality mistrust and lack of availability. However, the Indian government has started what is known as Jan Aushadhi shops, which are exclusive generic medication stores. When prescribing and delivering medications, doctors and pharmacists face a conundrum. The Indian government is encouraging the use of generic pharmaceuticals to lower the cost of health care. How well pharmacists and physicians embrace these initiatives will be crucial. Although it is among the less-discussed issues in medical school, using generic drugs and their accessibility is crucial for providing people with affordable healthcare. The study had considered 213 respondents to know the factors that determines the “Perception towards generic and branded medicines” and its impact on the acceptability of generic medications and concludes that there is significant impact of “perception towards generic and branded medicines” on the acceptability of generic medications

Consumer Information and Pharmaceutical Prices: Theory and Evidence

In this paper, the impact of increased information on brand name and generic pharmaceutical prices is analyzed both theoretically and empirically. The theoretical results show that an increase in information is likely to reduce the price of brand name pharmaceuticals, while the results regarding generics are less clear. In the empirical part of the paper, the introduction of the substitution reform in the Swedish pharmaceuticals market in October 2002 is used as a natural experiment regarding the effects of increased consumer information on pharmaceutical prices. The results clearly show that the reform has lowered the price of both brand name- and generic pharmaceuticals.

Squeezing the Last Drop Out of Your Suppliers: An Empirical Study of Market‐Based Purchasing Policies for Generic Pharmaceuticals

We study the effect of the degree of exclusivity for the lowest bidder on the average price of generic pharmaceuticals in the short and long terms. Our results indicate that a 1-percentage-point gain in market share of the lowest bidder reduces average costs by 0.3% in the short term and 0.8% in the long term, but also reduces the number of firms by 1%. We find that reducing the number of firms has a strong positive (and hence counteracting) effect on average prices, i.e., a 1% reduction raises prices by approximately 1%.

EVALUATING THE HATCH-WAXMAN AMENDMENT’S INFLUENCE ON FDA'S GENERIC MEDICATION APPROVAL PROCESS

Generics are drugs marketed by their chemical names, not brand names or chemical compositions. Generic drugs are less expensive. The United States Food and Drug Administration (USFDA) allows generic drugs when patents expire or owners renounce their rights. Competition lowers drug prices once generics are accessible. The Food and Drug Administration monitors the drug business. The Senate confirms the Food and Drug Administration Commissioner's nomination. Food and medications are controlled less than lasers, cell phones, and condoms. The Food & Drug Administration designated 1938–1962 medications as "pioneer goods. Kefauver-Harris requires all drug firms to submit accelerated applications (Abbreviated New Drug Application). Medicaid and Medicare modifications to the Social Security Act popularised generic medications. The 1984 law accelerated the launch of generic pharmaceuticals law and boosted generic drug introduction. The 1992 Generic Medication Enforcement Act combats fraud and misuse. The 1984 law accelerated the launch of generic pharmaceuticals.

STUDY ON TALENT MANAGEMENT PRACTICES IN PHARMA SECTOR WITH FOCUS ON "EMPLOYEE RETENTION”

The pharmaceutical sector in India currently holds a dominant position in the market for generic pharmaceuticals around the world. The industry is characterized by a one-of-a-kind mixture of both opportunities and limitations. It has achieved the global excellence standards in the mass manufacture of high-quality branded generics, which was driven by its capabilities in formulations that are of world-class standard. This achievement was driven by the fact that it has attained the mass manufacturing of branded generics. These are the result of prolonged expenditures in infrastructure and research & development on the part of industry leaders, who were also responsible for their creation. In addition, there are a huge number of small and medium-sized firms, which contributes to the industry's highly fragmented nature. The purpose of this study are to investigate the factors that contribute to employee turnover in the Indian context generally and in the pharmaceutical industry and to outline a deeper understanding of the strategies that are used for talent management and employee retention in the pharmaceutical industry.The pharmaceutical industry in India has the greatest employee turnover rate, and each industrial unit within the sector uses a unique combination of criteria and procedures to choose its talent, deliver its training, and take its various capacity-building steps. There is also a significant financial reward connected with work performance in the form of salaries and other benefits. Even with all of the necessary efforts, the retention of highly skilled employees to grass root functionaries continues to be a repeated pattern; nevertheless, the causes and impact of this phenomenon are not disclosed to aid the companies. As a consequence of this, the collecting of primary material became obligatory in order to investigate the subject in depth and evaluate the impact of the attrition problem. The secondary sources of information that were utilised in the research study have been appropriately acknowledged, and the primary data that the research scholar gathered, organized, and assessed on their own have been appropriately analyzed. The pharmaceutical sector relies on an extensive network of medical representatives, each of whom is individually tasked with driving sales of their company's wares in the marketplace. The grass-roots functionaries encompass a vast number of individuals in this category. The suggestions for lowering the rate of employee turnover are, for the most part, based on the field response from the respondents as well as management from the firms. The study was conducted in Chennai city during the month of January 2022. The primary data was collected using Google forms.

Price Transparency and Consumer Perceptions of Generic and Brand-name Implants in Orthopaedic Surgery.

Some have suggested the use of generic surgical implants to curb rising costs of orthopaedic care. However, there is evidence that patients are reluctant to use generic pharmaceuticals as compared to their brand name equivalents for fear of inferior quality. Public perception of the use of generic implants remains unknown. We conducted a cross-sectional survey using Amazon MTurk to identify factors associated with a consumer preference for generic orthopaedic screws and total hip. While much of the public (52%) sees the value of generic implants, fewer (26%) would prefer them in their own care. Most respondents (75%) trust their surgeon's choice, yet the vast majority (83%) want to be informed about the cost of their implant, even if it makes no difference in what they pay. The agreement that older implants are safer than newer implants (OR 1.9 for screws; 2.5 for hip arthroplasty), and that generics are a better value than brand name implants (OR 3.0 for screws; 4.3 for hip arthroplasty) were independently associated with a preference for generics. The observation that many people view generic implants as being a good value, yet fewer would prefer to use them in their own care indicates that concerns over quality may initially limit utilization of generic implants. More evidence is needed to reassure most consumers of the safety and effectiveness of generic implants. Additionally, our findings demonstrate a desire for more implant price transparency when undergoing orthopaedic surgery.

‘We care… because care is growth’. The low-tech imaginaries of India's small-scale pharmaceutical enterprises

Since the early 2000s, the development of India's generic industry has generated a lot of hope and interest amongst researchers and practitioners of Global Health. This article documents the ambiguous dreams, aspirations, and hopes of the managers of micro, small, and medium companies involved in manufacturing, marketing, and distributing low-cost generic medicine. The analysis draws on semi-structured interviews with managers (n ​= ​66) and shows that they contrast sharply with the universalist, tech-intensive, and salvationary imaginaries often associated with the global pharmaceutical industry. On the one hand, India's small-scale entrepreneurs see themselves as instrumental to their family's financial welfare and the economic development of their local social groups. On the other hand, they like to imagine themselves as part of India's emergence on the international stage and better global access to affordable medicine. Such imaginaries form a low-tech approach to Global Health where generic pharmaceuticals are not taken as transformative technologies but are meant to play specific socioeconomic roles at different scales.

Impact of patent (Amendment) act, 2005 on Indian pharmaceutical industry with reference to R&D expenditure, profit, export and sales

The Indian pharmaceutical business is the world's third-largest pharmaceutical sector in terms of volume, but it ranks 14th in terms of value. The lower position in terms of value might be due to the fact that Indian pharmaceutical enterprises are mostly focused on low-cost generic pharmaceuticals, with a broad range of company sizes and product mix. Because of Trade Related Intellectual Property Rights (TRIPS) restrictions, the Indian pharmaceutical business has undergone significant transformation since 1995. TRIPS ratification has had a considerable effect on Indian pharmaceutical industries. The effect of TRIPS on the Indian pharmaceutical industry’s R&D Expenditure, profit, export and sales is examined using a dummy variable in this research. Various industrial performance drivers, such as knowledge-based resources and property-based resources, are considered. The research considers a sample of 25 Indian pharmaceutical enterprises over a twenty-five year period (1996-2020). The results show that the Indian pharmaceutical industry is significantly impacted by TRIPS compliance. The findings of this study also emphasize the relative impact of various company resources on the performance of Indian pharmaceutical enterprises.

Green Chemistry in the Synthesis of Pharmaceuticals.

The principles of green chemistry (GC) can be comprehensively implemented in green synthesis of pharmaceuticals by choosing no solvents or green solvents (preferably water), alternative reaction media, and consideration of one-pot synthesis, multicomponent reactions (MCRs), continuous processing, and process intensification approaches for atom economy and final waste reduction. The GC's execution in green synthesis can be performed using a holistic design of the active pharmaceutical ingredient's (API) life cycle, minimizing hazards and pollution, and capitalizing the resource efficiency in the synthesis technique. Thus, the presented review accounts for the comprehensive exploration of GC's principles and metrics, an appropriate implication of those ideas in each step of the reaction schemes, from raw material to an intermediate to the final product's synthesis, and the final execution of the synthesis into scalable industry-based production. For real-life examples, we have discussed the synthesis of a series of established generic pharmaceuticals, starting with the raw materials, and the intermediates of the corresponding pharmaceuticals. Researchers and industries have thoughtfully instigated a green synthesis process to control the atom economy and waste reduction to protect the environment. We have extensively discussed significant reactions relevant for green synthesis, one-pot cascade synthesis, MCRs, continuous processing, and process intensification, which may contribute to the future of green and sustainable synthesis of APIs.

The Teaching and Learning of Pharmacokinetic Subjects to Pharmacy Students: Review of Teaching Strategies

<p style="text-align: justify;">A strong foundation in pharmacokinetics is essential not only to provide effective therapeutic outcomes for patients but also crucial to the pharmaceutical industry and the regulation of generic pharmaceuticals. Bioequivalence is an important regulatory concern for a pharmaceutical company in the manufacture of generic drugs. Pharmacokinetics should be mastered by pharmacy students to prepare them for their future careers, particularly in a hospital setting where pharmacists typically play a central role in clinical pharmacokinetics services. However, basic pharmacokinetics is sometimes not well-received by students because of its basis in mathematics and the relative difficulty in connecting basic concepts with clinical relevance. This narrative literature review examines the methodologies employed to teach pharmacokinetics, the move towards computer-aided and distance learning, and the current software systems available to facilitate this. A better understanding of the limitations of current approaches is crucial to take steps to enhance the teaching and learning of such an important subject. <strong>Key words:</strong> Pharmacokinetic software, Pharmacy education.

Generic Pharmaceuticals as a Source of Diuretic Contamination in Athletes Subject to Sport Drug Testing.

This paper describes nine instances of positive anti-doping tests that could be accounted for by the use of permitted generic prescription drugs contaminated with diuretics, which are prohibited in sport at all times under the WADA Prohibited List. The contamination levels found in the medications are reported and were below FDA limits for manufacturers that are based primarily on safety considerations. These cases demonstrate that great care must be taken to identify the source of low-level anti-doping positives for diuretics reported by WADA-accredited laboratories, and possibly other prohibited substances as well, in order to avoid sanctioning innocent athletes. An evaluation of the cases in this paper supports an approach which establishes a laboratory minimum reporting level (MRL) for diuretics found most commonly in medications. A global consensus after extensive review of similar anti-doping cases has resulted in implementation of a recently announced solution regarding potential diuretic contamination cases.

Co-Crystals for Generic Pharmaceuticals: An Outlook on Solid Oral Dosage Formulations.

Co-crystal is an attractive alternative and a new class of solid forms because that can be engineered to have desired physicochemical properties. Co-crystals have gained considerable attention from the generic pharmaceutical industry after the USFDA released its finalized guidlines in the year 2018 on the regulatory classification of co-crystals. In this review, we discussed how co-crystals could be explored as a potential alternative solid form for the development of a generic product that meets the legal, regulatory, and bioequivalence requirements. In the contents, we discussed in detail concepts such as the selection of coformers, various ways of making co-crystals, the strategy of characterization to discriminate between co-crystal and salt, polymorphism in co-crystals, the aspects of intellectual property and, finally, the regulatory aspects of co-crystals.

Brand drug companies impeding generic drug company access to product samples: Estimated prevalence and impact on drug costs

Some brand drug companies have stymied attempts by generic drug companies to obtain samples of brand drugs needed to develop and gain regulatory approval for their generic products. This conduct, which has been reported in both the US and Canada, raises drug costs to drug plans and other payors and can lessen competition. The literature to date contains little empirical evidence on the prevalence of this conduct, the attendant effects on generic drug market launches and costs incurred by drug payors. This paper addresses these questions for Canada, using data on the drug development projects undertaken by the members of the Canadian Generic Pharmaceutical Association over the period 2015–2019. I found that about 16% of generic drug development projects were delayed due to originator firm efforts to impede access to samples of their drugs. The median generic drug launch delay (among affected drugs) attributable to the challenged conduct was 6 months. The additional costs to drug payors from the resulting delays in generic drug launches over the analysis period was in the order of $284 million, or $57 million annually. This study did not explore the additional generic drug development costs attributable to the challenged conduct.