STAT News

AUGUST 22, 2022

After a decade of manufacturing problems, a U.S. federal court ordered a unit of Wockhardt, one of the largest makers of generic drugs, to refrain from making allegedly adulterated medicines at a facility in Illinois. However, the U.S.

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BioSpace

AUGUST 29, 2023

Lupin Pharmaceuticals' recall of Tydemy birth control is the latest in a string of problems with India-based generic drug manufacturers.

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NY Times

SEPTEMBER 18, 2021

Competition for market share at rock-bottom prices has led to shortages, price-spikes, allegations of price-fixing, and substandard and even dangerous practices.

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STAT News

AUGUST 3, 2022

In the latest bid to address high prescription drug costs, a nonprofit plans to sell a cheaper generic version of an expensive cancer medicine in the U.S.

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Pharma in Brief

FEBRUARY 8, 2024

The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission ( ANDS ).

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Pharmacy Checkers

MAY 22, 2020

One of our more popular Ask PharmacyChecker posts is called “ How can I determine where a drug is manufactured? ” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S. has the pharmaceutical ingredients it needs to make drugs that treat people with Covid-19.

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Various factors have contributed to the need and growth of API chemical suppliers such as rising healthcare expenditure, increasing disposable incomes, growing geriatric population, increasing incidence of chronic diseases, patent expiration of blockbuster drugs, increased consumption of generic drugs, and intervention of the new generation APIs.

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FDA Law Blog

APRIL 2, 2024

Under the heading “Facilitating Competition” are multiple initiatives designed to either hasten development of generic drugs or limit blockades to market. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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FDA Law Blog

AUGUST 16, 2023

Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

increase in revenue from 2020 to 2021 from sales of Revlimid, its multiple myeloma therapy, with a global analyst consensus sales forecast of $12.8bn for 2021, according to GlobalData’s Drugs Database. However, other challenges facing biopharmaceutical companies include growing generic drug competition, which places pressure on drug prices.

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Outsourcing Pharma

OCTOBER 20, 2020

The generic drug manufacturer is working with Kit Check to incorporate the company's drug supply-chain management technology into two of its products.

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Pharma in Brief

APRIL 29, 2021

At the end of 2016, the previous Quebec government prohibited a number of common commercial practices by drug manufacturers and pharmacists with the aim of fostering greater price competition between drug manufacturers and reducing the cost of the public drug insurance scheme. [1].

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World of DTC Marketing

APRIL 12, 2021

The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. Ironically, in later times, the intense competition for out-of-patent drugs has subsided, which has led to spiraling rises in generic drug prices and shortages.

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Outsourcing Pharma

OCTOBER 5, 2021

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations.

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FDA Law Blog

APRIL 8, 2024

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. MRAP would provide oversight of an accreditation body which would conduct assessments—paid for by the manufacturer—based on criteria developed by the MRAP. In Section I.A,

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Pharmaceutical Technology

MAY 31, 2023

Les Laboratoires Servier overview Les Laboratoires Servier (Servier) researches, develops, manufactures, and markets drugs for treating various diseases. The company also provides generic drugs and contract development and manufacturing services across its global network.

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FDA Law Blog

APRIL 8, 2024

This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. Readers also saw that that the Center’s manufacturing Site Catalog remains steady at more than 4,800 entries, the same number we found in the 2022 State of Pharmaceutical Quality report.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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BioTech 365

MAY 18, 2021

OTC PINK:SHMN), a generic pharmaceutical, nutraceutical, and cosmeceutical company that manufactures and markets generic drugs covering … Continue reading → Chino Hills, 05/18/2021 / 15:31, CET/CEST – EQS Newswire – Sohm, Inc. CHINO HILLS, CA / ACCESSWIRE / May 18, 2021 / SOHM, Inc.

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BioTech 365

JUNE 3, 2021

the “Company”) (OTC PINK:SHMN), generic Pharmaceutical, Nutraceutical, and Cosmeceutical company that manufactures and markets generic drugs … Continue reading → CHINO HILLS, CA / ACCESSWIRE / June 3, 2021 / SOHM, Inc.

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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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FDA Law Blog

MAY 25, 2022

That effort, which has most recently emerged in the forms of the “ Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2021 ” ( H.R. 2853 , or “BLOCKING Act”), the “ Expanding Access to Low-Cost Generics Act of 2021 ” ( S. And now there’s a report and analysis to back up that claim!

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XTalks

MARCH 15, 2024

It also introduced a feature that allows users to use coupons at checkout to get manufacturer discounts on brand name medications. Amazon Pharmacy says it is focused on transparent pricing and affordability of both branded and generic drugs. The subscription includes medicines for high cholesterol, anxiety and acid reflux.

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FDA Law Blog

NOVEMBER 20, 2023

Of note, the new structure removes any separation between new and generic drug quality review offices. For example, in August, CDER and OPQ initiated the Quality Management Maturity Program (QMM) that aspires to “implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements.”

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The Pharma Data

MAY 16, 2021

India’s surging COVID-19 cases threaten to derail the global drug supply as the world’s largest producer of generic drugs is unable to secure critical raw materials. The crisis has serious implications for the U.S.,

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Other contributing factors include the decreasing number of post-market studies and difficulties in primary research and manufacturing. A lower number of clinical trials and regulatory filings were other important influences behind the decision.

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pharmaphorum

JUNE 6, 2022

The costs associated with the supply chain, rather than solely the cost of making the drug, raise the end price of medications, which are then passed onto consumers. MCCPDC’s site says it can lower prices by directly opening the pathway from manufacturers to consumers, decreasing medicine costs by cutting unnecessary expenses.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

. · Prescription refill and generic drug programmes. Proprietary pharmaceutical, nutraceutical, and cosmeceutical products. Prescription collection lockers.

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FDA Law Blog

AUGUST 16, 2022

Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. By Douglas B.

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pharmaphorum

JULY 28, 2022

The pandemic effectively shut down supply chain paths overnight, and as a result, pharmaceutical manufacturers have faced delays and bottlenecks, which have caused drug shortages in healthcare systems. So, what can we do to insulate against the risk of shortages in these crucial generic drugs?

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FDA Law Blog

JULY 22, 2021

Schlanger — Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. Both states’ new requirements will become effective in October 2021 and should be considered as manufacturers prepare for state drug price transparency reporting in 2022.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § 355(j)(2)(A)(v). FDA regulations, at 21 C.F.R.

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Pharma in Brief

APRIL 25, 2021

salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers to file an ANDS for an alternative form of a medicinal ingredient in comparison to the CRP. Proposed FDR Amendments Create Imbalance in Linkage Regime.

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Pharma in Brief

NOVEMBER 5, 2023

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary.

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pharmaphorum

JANUARY 25, 2022

.” The online pharmacy launch comes a few weeks after Cuban set up a pharmacy benefit manager (PBM) operation – the Mark Cuban Cost Plus Drug Company (MCCPDC) – promising to cut out the middleman in the medicines supply chain so it can eliminate markups on generic drugs and pass savings on to its customers.

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