Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData.

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Manufacturing Generic Drugs Contract Manufacturing Production 130

Fierce Pharma

JUNE 6, 2024

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |

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Manufacturing Contamination Drugs 91

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. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

DECEMBER 8, 2022

This process is used to manufacture pharmaceutical products with low molecular weights in large batches within a short timescale. The chemical synthesis process enables various chemical modifications to be made in order to enhance the activity of the drug produced. Chemical synthesis solutions.

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Containment Contamination Manufacturing Production 245

Pharmaceutical Technology

APRIL 27, 2023

The successful development and deployment of the mRNA-based COVID-19 vaccines has catalysed the biopharma industry and paved the way to expand this drug modality to new therapeutic areas. This makes the requirement to establish a reliable and robust manufacturing process with clear scalability and compliance goals a priority.

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Manufacturing RNA Contamination Vaccination 130

XTalks

MAY 19, 2022

According to the company, products were manufactured by a third party and subsequently distributed across North America. The US Food and Drug Administration (FDA) posted the company’s recall announcement , which includes a complete list of products affected by the recall. . ounce to 12-ounce share size bags of gummies.

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Pharmaceutical Technology

OCTOBER 26, 2022

Nano-based delivery systems are on the rise, as they enable manufacturers to deliver therapeutic agents to specific targeted tissue in a more controlled manner. Data indicates that the global nanopharmaceutical drugs market size reached USD 53.85 Billion in 2021 and is expected to reach USD 102.4 Billion in 2030.

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Manufacturing Drug Delivery Systems Contamination Drug Delivery 130

Fierce Pharma

APRIL 10, 2024

It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. | In a four-observation warning letter issued this week, the U.S.

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Contamination Manufacturing Production Drugs 87

Roots Analysis

JANUARY 27, 2025

These therapies have emerged as viable alternatives to traditional treatment options, including small molecule drugs. It is worth mentioning that the past few decades have witnessed several advances in this domain, particularly in the cell therapy manufacturing process. This figure presents the cell therapy manufacturing steps.

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Manufacturing Contamination Production Gene Therapy 40

STAT News

APRIL 3, 2023

Your tips and insights help the world go around… Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated , according to a U.S. Food and Drug Administration inspection report obtained by STAT.

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Manufacturing Contamination Research Production 97

XTalks

DECEMBER 14, 2020

AvKARE, a generics pharmaceutical manufacturer based in Pulaski, Tennessee, has issued a recall on one lot each of its sildenafil 100 mg tablets and trazodone 100 mg tablets due to a packaging “mix-up” in which both drugs were filled into the same bottle. AvKARE said the mispackaged drugs were distributed nationwide.

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Drug Patent Watch

DECEMBER 17, 2024

Contract Development and Manufacturing Organizations (CDMOs) are at the forefront of this shift, playing a crucial role in bringing innovative therapies to market. Today, they’re strategic partners in drug development and manufacturing, offering end-to-end solutions that can make or break a pharmaceutical company’s success.

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XTalks

MARCH 25, 2022

The affected medications include six lots of Accuretic tablets and batches of two authorized generics of the drug distributed by Greenstone that include one lot of quinapril and hydrochlorothiazide tablets and four lots of quinapril HCl/hydrochlorothiazide tablets.

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Contamination Drugs Production Manufacturing 95

Pharmaceutical Technology

JANUARY 6, 2023

The preparation of a semi-solid dosage form – from formulation and development, to scale-up, commercial manufacturing, and packaging – should ideally take place under one roof in a contiguous, end-to-end workflow to avoid unnecessary equipment and process changes. Optimising development and scale-up.

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Pharmaceutical Technology

MARCH 22, 2023

The demand for injectable drugs is rising. According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. Several drug development trends are driving injectables demand.

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STAT News

JANUARY 19, 2023

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.

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STAT News

MARCH 31, 2023

Global Pharma Healthcare, whose eye drops have been linked to dozens of serious reactions, failed to follow numerous procedures to ensure its products did not become contaminated, according to a Food and Drug Administration inspection report obtained by STAT.

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Contamination Manufacturing Production Drugs 105

STAT News

JANUARY 10, 2023

Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems. Sun Pharmaceutical, one of the world’s largest generic drugmakers, was scolded by the U.S.

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Contamination Regulation Manufacturing Production 105

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties.

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Regulation Drugs Manufacturing Production 98

Pharmaceutical Technology

DECEMBER 6, 2022

Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. HPAPIs may now represent more than 30% of the drug development pipeline. Nowadays, you have drugs against cancer which have a very high impact even at a very low dosage.”.

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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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Pharmaceutical Technology

MAY 11, 2008

Pharmaceutical companies, regulatory agencies and governments are becoming increasingly concerned about fraud and counterfeiting throughout the pharmaceutical supply chain, especially with the cost of drugs going up. RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs.

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Drugs Packaging Packaging Production 100

XTalks

AUGUST 12, 2024

The presence of lead in food remains a critical concern for the US Food and Drug Administration (FDA). Lead, a toxic metal, can enter the food supply through environmental contamination during the growing, raising or processing of foods. If you want your company to be featured on Xtalks.com, please email sydneyp@xtalks.com.

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Contamination Compliance Regulation Production 105

Medical Xpress

APRIL 17, 2023

An analysis of global usage patterns of a common hypertension drug following a major recall demonstrates the worldwide impact of contamination at a single manufacturing facility.

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Contamination Drugs Manufacturing 55

Camargo

AUGUST 5, 2021

Approval of the Month: Repurposed Transplant Drug Approved Based Only on Real-World Evidence. Though domestic inspections resumed in July, hundreds of drug plant inspections must be cleared that have piled up in the FDA backlog during the COVID-19 pandemic. Over about three pages, 13 questions were posed.

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Pharmaceutical Technology

DECEMBER 20, 2022

Maintaining sterility is critical in the final steps of parenteral drug processing, ensuring doses are free from microbial contamination that could affect patient safety. With operator intervention being a primary source of contamination, finding ways to reduce human contact has been an ongoing challenge and goal in aseptic filling.

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Regulation Contamination Manufacturing Production 130

XTalks

SEPTEMBER 17, 2020

The US Food and Drug Administration (FDA) has issued its first injunction under the Produce Safety Rule against Fortune Food Product Inc., The company has agreed to stop production until it takes remedial action and complies with the Federal Food, Drug, and Cosmetic Act. an Illinois-based processor of sprouts and soy products.

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Production Contamination Cosmetics Bacteria 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

Research by GlobalData (Contract Small Molecule API Manufacturing Industry by the Numbers – 2021 Edition) shows that containment facilities are in high demand as the use of cytotoxic drugs continues to grow. This suggests a move towards high-value specialised manufacturing. What is driving the surge in demand for APIs?

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Containment Manufacturing Production Contract Manufacturing 130

Fierce Pharma

FEBRUARY 20, 2024

It’s been 15 years since Genzyme began rationing the Fabry disease treatment Fabrazyme after a shortage caused by contamination at a manufacturing site, marking the start of many years of litigatio | Sanofi's Genzyme was accused of causing injuries after contaminated doses of its Fabry disease drug led to a shortage, during which the company rationed (..)

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Contamination Manufacturing Drugs 59

NY Times

MAY 10, 2022

The report sheds new light on executives’ worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant; no contaminated doses were ever released to the public.

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Contamination Vaccination Vaccine Manufacturing 95

XTalks

JULY 22, 2021

Pfizer is recalling three more lots of its smoking cessation drug Chantix (varenicline) after having issued a voluntary recall of the drug earlier this month due to carcinogen concerns, bringing the total number of affected lots to 12. As a result, there are currently shortages of the drug in the US. mg and 1 mg doses.

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Drugs Doctor Doctors Branding 98

pharmaphorum

FEBRUARY 15, 2022

The findings point to a “threat to environmental and global health,” say the scientists, who found that paracetamol, antibiotics epilepsy drug carbamazepine, metformin for diabetes and other compounds like caffeine and nicotine were found in samples from around the world – including in Antarctica.

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Contamination Manufacturing Scientist Research 105

The Pharma Data

MARCH 29, 2022

Food and Drug Administration (FDA) announced today that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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Manufacturing Contamination Cosmetics Regulation 52

Pharmaceutical Technology

FEBRUARY 3, 2023

As opposed to other therapies or drugs that basically help you manage a condition, gene therapy has the potential to cure a disease,” says Nicole Faust, PhD, General Manager, Cell Line Development, Cytiva. Rather, he believes adaptation to suspension-based systems will be an important evolution in AAV manufacturing. Biores Open Access.

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XTalks

AUGUST 7, 2023

coli outbreak between 1992 and 1993 that claimed the lives of four children who had eaten contaminated burgers from the fast-food chain Jack in the Box. The spotlight frequently fell on corporate executives and government regulators in the Netflix food documentary, these being the usual suspects behind food contamination.

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Pharmaceutical Technology

MAY 2, 2023

The pharmaceutical industry is constantly striving for better, cleaner, safer manufacturing, especially when it comes to injectable medicines. Datwyler is a leading provider of parenteral packaging components and is helping the industry put quality first through the invention of the FirstLine® manufacturing standard.

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Packaging Packaging Production Contamination 130

XTalks

AUGUST 12, 2020

Thomson International, a company based out of Bakersfield, California, has recalled red, yellow, white and sweet yellow onions shipped from May 1, 2020 until now due to potential Salmonella contamination. of Bakersfield, California, USA, or any products made with these onions. More about Salmonella.

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Contamination Production Bacteria Nurses 78