Cost of goods sold analysis and recommendations to reduce costs of co-packaged mifepristone–misoprostol for medical abortion

Abstract Objective Understanding the price components of the mifepristone/misoprostol (combi-pack) for medical abortion to improve access is critical for identifying strategies to reduce product costs for quality-assured formulations and expanding its availability and use. Methods We constructed a cost of goods sold analysis using data collected from manufacturing companies in Bangladesh, China and India supported by publicly available information related to the product formulation, active pharmaceutical ingredients (API), manufacturing location, manufacturer profiles and other individual model components. Key model components were the active pharmaceutical ingredients (quality-assured or not), excipients, labour cost, operating cost and packaging. Results Combi-pack direct production cost ranges from US$1.08 for finished products which are not quality assured to US$3.05 for products containing quality assured active pharmaceutical ingredients, which means that with a 30% administrative fee applied to those prices, it could be made available between US$1.40 and US$3.97 depending on location, manufacturer’s profile, optimal market situation and the quality of the active pharmaceutical ingredients. The main model component impacting on the cost range is the purchase price of mifepristone active pharmaceutical ingredient and the current differential between quality-assured material supported by adequate documentation and API for which quality assurance cannot be demonstrated. Compared to India cost of goods sold is lower in Bangladesh primarily due to lower operating costs, including the cost of labour. Conclusions It is feasible to lower the cost of quality-assured combi-packs, through reducing mifepristone API cost and selection of the manufacturing location. However, manufacturers need to be incentivised to achieve WHO pre-qualification with a carefully built business case and require support in identifying and sourcing competitively priced material and manufacturing products to the necessary standard.

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DOMESTIC APIS AND INTERMEDIATES – THE NEED OF THE HOUR

INDIAN DRUGS ◽

10.53879/id.55.09.p0005 ◽

2018 ◽

Vol 55 (09) ◽

pp. 5-6

Author(s):

George Patani ◽

Keyword(s):

Pharmaceutical Industry ◽

Multiple Representations ◽

Active Pharmaceutical Ingredients ◽

Current Crisis ◽

Pharmaceutical Ingredients ◽

Essential Drugs ◽

Current Events ◽

Dear Reader ◽

The Cost

Dear Reader, As I write this editorial, some of the current events that we are faced with in the pharmaceutical industry in INDIA, bears greatly on my mind. The exponential rise in the cost of a large number of APIs is causing great anguish and stress for formulation manufacturers. The rise in the cost of these APIs or their intermediates sourced from China is attributed as the reason for this increase. As a result, a number of essential drugs are experiencing shortages in various parts of our country. The year 2015 was declared as the year of ACTIVE PHARMACEUTICAL INGREDIENTS (APIs) by the Department of Pharmaceuticals. While we still await the announcement of concessions based on the multiple representations made to the various ministries, the current crisis maybe a god sent opportunity for the domestic API manufacturers to restart manufacturing a number of the APIs that were uneconomical due to price pressures from APIs produced in China

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Estimation of cost-based prices for injectable medicines in the WHO Essential Medicines List

BMJ Open ◽

10.1136/bmjopen-2018-027780 ◽

2019 ◽

Vol 9 (9) ◽

pp. e027780 ◽

Cited By ~ 1

Author(s):

Dzintars Gotham ◽

Melissa Joy Barber ◽

Andrew M Hill

Keyword(s):

South Africa ◽

Universal Access ◽

Pharmaceutical Product ◽

Essential Medicines ◽

Active Pharmaceutical Ingredients ◽

Profit Margins ◽

Pharmaceutical Ingredients ◽

Oral Formulations ◽

Current Price ◽

The Cost

ObjectivesChallenges remain in ensuring universal access to affordable essential medicines. We previously estimated the expected generic prices based on cost of production for medicines in solid oral formulations (ie, capsules or tablets) on the WHO Model List of Essential Medicines (EML). The objectives of this analysis were to estimate cost-based prices for injectable medicines on the EML and to compare these to lowest current prices in England, South Africa, and India.DesignData on the cost of active pharmaceutical ingredients (APIs) exported from India were extracted from an online database of customs declarations (www.infodriveindia.com). A formula was designed to use API price data to estimate a cost-based price, by adding the costs of converting API to a finished pharmaceutical product, including the cost of formulation in vials or ampoules, transportation and an average profit margin.ResultsFor injectable formulations on the WHO EML, medicines had prices above the estimated cost-based price in 77% of comparisons in England (median ratio 2.54), and 62% in South Africa (median ratio 1.48), while 85% of medicines in India had prices below estimated cost-based price (median ratio 0.30). 19% of injectable medicines in England, 9% in South Africa, and 5% in India had prices more than 10 times the estimated cost-based price. Medicines that appeared in the top 20 by ratio of lowest current price to estimated cost-based price for more than one country included numerous oncology medicines—irinotecan, leuprorelin, ifosfamide, daunorubicin, filgrastim and mesna—as well as valproic acid and ciclosporin.ConclusionsEstimating manufacturing costs can identify cases in which profit margins for medicines may be set significantly higher than average.

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Three Scenarios in Microgrid to Solve Management Problem for Residential Application Using Genetic Algorithms

Handbook of Research on Novel Soft Computing Intelligent Algorithms - Advances in Computational Intelligence and Robotics ◽

10.4018/978-1-4666-4450-2.ch019 ◽

2014 ◽

pp. 568-588

Author(s):

Faisal A. Mohamed

Keyword(s):

Genetic Algorithms ◽

Operating Cost ◽

Economic Problem ◽

Management Problem ◽

Total Load ◽

Operation And Maintenance ◽

Online Management ◽

Power Utilities ◽

Model Components ◽

The Cost

This chapter discusses online management of the MicroGrid components. A major challenge for all power utilities is not only to satisfy the consumer demand for power, but to do so at minimal cost and low emissions. Any given power system can be comprised of multiple generating units each of which has its own characteristic operating parameters. The operating cost and emission level of these generators usually correlate proportionally with their outputs, therefore the challenge for power utilities is to balance the total load among generators that are running as efficiently as possible. One of the important applications of the MicroGrid (MG) units is the utilization of small-modular residential or commercial units for onsite service. Genetic Algorithms (GA) optimization is well-suited to solve the environmental/economic problem of the MG. The proposed problem is first formulated as a nonlinear constrained optimization problem. Prior to the optimization, system model components from real industrial data are constructed. The model takes into consideration the operation and maintenance costs as well as the reduction in NOx, SO2, and CO2 emissions. The optimization is aimed at minimizing the cost function of the system while constraining it to meet the customer demand and safety of the system. The results ensure the efficiency of the proposed approach to satisfy the load and to reduce the cost and the emissions in one single run.

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ANALISIS PERHITUNGAN HARGA POKOK PRODUKSI DAN PENENTUAN HARGA JUAL ATAS PRODUK (Studi Kasus Pada PT Dasa Windu Agung)

Jurnal Riset Manajemen dan Bisnis (JRMB) Fakultas Ekonomi UNIAT ◽

10.36226/jrmb.v1i2.23 ◽

2016 ◽

Vol 1 (2) ◽

pp. 183-190

Author(s):

Dwi Urip Wardoyo

Keyword(s):

Manufacturing Industry ◽

Sampling Method ◽

Manufacturing Companies ◽

Test Analysis ◽

Automotive Components ◽

Convenience Sampling ◽

Cost Of Production ◽

The Cost ◽

Keywords Cost

This study aims to determine the determination of the cost of production for products produced by PT. DWA. The Company is engaged in the manufacturing industry specialized in automotive components. Its activity is carried out through a series of production processes, so that expenses spent in the production will be calculated into the cost of the production sold. The population in this study were all manufacturing companies in Jakarta. Convenience sampling method selected one of the companies that get the confidence to assemble three national car project in Indonesia, namely Timor, Bakrie and Maleo. Test analysis used in this study is to test the calculation of full costing with job order costing. This study shows that (a) determination of the cost elements associated with the cost of production and (b) determining the cost of production on a product-based job costing with full costing approach. Keywords: cost of production, full costing

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Reversed-Phase High Performance Liquid Chromatographic Analysis of Three First Line Anti-Tuberculosis Drugs

Revista de Chimie ◽

10.37358/rc.18.12.6799 ◽

2019 ◽

Vol 69 (12) ◽

pp. 3590-3592

Author(s):

Nela Bibire ◽

Romeo Iulian Olariu ◽

Luminita Agoroaei ◽

Madalina Vieriu ◽

Alina Diana Panainte ◽

...

Keyword(s):

High Performance ◽

Biological Fluids ◽

Gradient Elution ◽

High Performance Liquid Chromatographic ◽

Reversed Phase ◽

Assay Method ◽

Active Pharmaceutical Ingredients ◽

First Line ◽

Pharmaceutical Ingredients ◽

Liquid Chromatographic

Active pharmaceutical ingredients such as isoniazid, pyrazinamide and rifampicin are among the most important first-line anti-tuberculosis drugs. A simple, rapid and sensitive reversed phase-high performance liquid chromatographic assay method for the simultaneous determination of isoniazid, pyrazinamide and rifampicin has been developed. Separation of the interest compounds was achieved in a 10 min chromatographic run in gradient elution mode on a Zorbax SB-C18 stainless steel column (150 � 4 mm, 5 mm) using a guard column containing the same stationary phase. The gradient elution was carried out with a mobile phase of 10% CH3CN aqueous solution for channel A and 50% CH3CN in pH = 6.8 phosphate buffer (20 mM), to which 1.5 mL triethylamine were added for channel B. Quantification of the analyzed substances was carried out spectrophotometrically at 269 nm. Detection limits of 0.48 mg/L for isoniazid, 0.52 mg/L for pyrazinamide and 0.48 mg/L for rifampicin were established for the developed assay method. The present work showed that the proposed analysis method was advantageous for simple and rapid analysis of the active pharmaceutical ingredients in pharmaceuticals and biological fluids.

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Numaswitch: an efficient high-titer expression platform to produce peptides and small proteins

AMB Express ◽

10.1186/s13568-021-01204-w ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Bach-Ngan Nguyen ◽

Florian Tieves ◽

Thomas Rohr ◽

Hilke Wobst ◽

Felix S. Schöpf ◽

...

Keyword(s):

Fermentation Broth ◽

High Titer ◽

New Technology ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Expression Platform ◽

Small Proteins ◽

Production Platform ◽

Β Amyloid ◽

Cost Efficient

AbstractThe production of peptides as active pharmaceutical ingredients (APIs) by recombinant technologies is of emerging interest. A reliable production platform, however, is still missing due the inherent characteristics of peptides such as proteolytic sensitivity, aggregation and cytotoxicity. We have developed a new technology named Numaswitch solving present limitations. Numaswitch was successfully employed for the production of diverse peptides and small proteins varying in length, physicochemical and functional characteristics, including Teriparatide, Linaclotide, human β-amyloid and Serum amyloid A3. Additionally, the potential of Numaswitch for a cost-efficient commercial production is demonstrated yielding > 2 g Teriparatide per liter fermentation broth in a quality meeting API standard.

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Diagnosis of Agglomeration and Crystallinity of Active Pharmaceutical Ingredients in Over the Counter Headache Medication by Electrospray Laser Desorption Ionization Mass Spectrometry Imaging

Molecules ◽

10.3390/molecules26030610 ◽

2021 ◽

Vol 26 (3) ◽

pp. 610

Author(s):

Mariann Inga Van Meter ◽

Salah M. Khan ◽

Brynne V. Taulbee-Cotton ◽

Nathan H. Dimmitt ◽

Nathan D. Hubbard ◽

...

Keyword(s):

Mass Spectrometry ◽

Mass Spectrometry Imaging ◽

Laser Desorption ◽

Ionization Mass Spectrometry ◽

Ionization Mass ◽

Active Pharmaceutical Ingredients ◽

Laser Desorption Ionization ◽

Over The Counter ◽

Pharmaceutical Ingredients ◽

Desorption Ionization

Agglomeration of active pharmaceutical ingredients (API) in tablets can lead to decreased bioavailability in some enabling formulations. In a previous study, we determined that crystalline APIs can be detected as agglomeration in tablets formulated with amorphous acetaminophen tablets. Multiple method advancements are presented to better resolve agglomeration caused by crystallinity in standard tablets. In this study, we also evaluate three “budget” over-the-counter headache medications (subsequently labeled as brands A, B, and C) for agglomeration of the three APIs in the formulation: Acetaminophen, aspirin, and caffeine. Electrospray laser desorption ionization mass spectrometry imaging (ELDI-MSI) was used to diagnose agglomeration in the tablets by creating molecular images and observing the spatial distributions of the APIs. Brand A had virtually no agglomeration or clustering of the active ingredients. Brand B had extensive clustering of aspirin and caffeine, but acetaminophen was observed in near equal abundance across the tablet. Brand C also had extensive clustering of aspirin and caffeine, and minor clustering of acetaminophen. These results show that agglomeration with active ingredients in over-the-counter tablets can be simultaneously detected using ELDI-MS imaging.

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Sulfanyl Porphyrazines with Morpholinylethyl Periphery—Synthesis, Electrochemistry, and Photocatalytic Studies after Deposition on Titanium(IV) Oxide P25 Nanoparticles

Molecules ◽

10.3390/molecules26082280 ◽

2021 ◽

Vol 26 (8) ◽

pp. 2280

Author(s):

Tomasz Koczorowski ◽

Wojciech Szczolko ◽

Anna Teubert ◽

Tomasz Goslinski

Keyword(s):

Diclofenac Sodium ◽

2D Nmr ◽

Oxide Nanoparticles ◽

Electrochemical Studies ◽

Macrocyclic Compounds ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Vis Spectroscopy ◽

Singlet Oxygen Quencher ◽

Nmr Techniques

The syntheses, spectral UV–Vis, NMR, and electrochemical as well as photocatalytic properties of novel magnesium(II) and zinc(II) symmetrical sulfanyl porphyrazines with 2-(morpholin-4-yl)ethylsulfanyl peripheral substituents are presented. Both porphyrazine derivatives were synthesized in cyclotetramerization reactions and subsequently embedded on the surface of commercially available P25 titanium(IV) oxide nanoparticles. The obtained macrocyclic compounds were broadly characterized by ESI MS spectrometry, 1D and 2D NMR techniques, UV–Vis spectroscopy, and subjected to electrochemical studies. Both hybrid materials, consisting of porphyrazine derivatives embedded on the titanium(IV) oxide nanoparticles’ surface, were characterized in terms of particle size and distribution. Next, they were subjected to photocatalytic studies with 1,3-diphenylisobenzofuran, a known singlet oxygen quencher. The applicability of the obtained hybrid material consisting of titanium(IV) oxide P25 nanoparticles and magnesium(II) porphyrazine derivative was assessed in photocatalytic studies with selected active pharmaceutical ingredients, such as diclofenac sodium salt and ibuprofen.

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US trade policy is putting at risk the sustainability of the generic/biosimilar industry and the drug supply chain

Journal of Generic Medicines The Business Journal for the Generic Medicines Sector ◽

10.1177/1741134321994316 ◽

2021 ◽

pp. 174113432199431

Author(s):

María Fabiana Jorge

Keyword(s):

Supply Chain ◽

Trade Policy ◽

Pharmaceutical Products ◽

Drug Supply ◽

Active Pharmaceutical Ingredients ◽

Pharmaceutical Ingredients ◽

Us Trade Policy ◽

Drug Supply Chain ◽

Security Concern ◽

The U.S

With the outbreak of the Coronavirus there is a new realization of the vulnerabilities of the U.S. drug supply chain. However, while such concerns may have been amplified by the pandemic, they preceded Covid-19 and were well documented before 2020. Indeed, in past years the U.S. Congress held several hearings addressing potential vulnerabilities in the U.S. drug supply chain, in part due to the increasing dependency on China as a dominant supplier of active pharmaceutical ingredients (APIs) and some finished pharmaceutical products. These vulnerabilities go well beyond health policy and constitute a national security concern. The article addresses how U.S. trade policy plays a significant role in shaping the pharmaceutical industry at home and abroad and is in part responsible for some of the current vulnerabilities of the U.S. drug supply chain.

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