European Pharmaceutical Review

JUNE 5, 2023

Article: NDMA: a recall trigger for the drug development industry … The recent discovery of small-molecule nitrosamine impurities in marketed drugs, starting with N -nitrosodimethylamine (NDMA) in batches of Valsartan in 2018, has led to significant regulatory response, the paper noted.

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Packaging 98

The Checkup by Singlecare

JULY 11, 2024

According to studies from 2008 and 2018 , prednisone and non-steroidal anti-inflammatory drugs are equally effective treatment options for gout. So people with gout should avoid high fructose corn syrup, packaged foods, processed foods—anything that comes from a package.”

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Dosage Packaging Immunization FDA 94

Druggist

MARCH 11, 2021

Patients should avoid using glycerin and lemon juice, which dehydrate the mouth and cause exhaustion of salivary secretions (NICE, 2018). HAp+ Dry Mouth Drops - 16 Strawberry & Rhubarb Flavoured Lozenges - Mouth Watering, Vegan, and Sugar Free - Maintains Healthy Teeth - Blister Pack - New Packaging (Strawberry & Rhubarb).

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Packaging Chemotherapy 97

Pharmaceutical Technology

MAY 26, 2023

During 2018–2022, the CMO industry had 479 mergers and acquisitions of whole companies or individual facilities, a GlobalData analysis shows. The acquisition targets had a wide variety of manufacturing services, including API and dose manufacturing, packaging, and analytical services.

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Packaging 52

European Pharmaceutical Review

DECEMBER 5, 2024

If not properly coated and packaged, Amoxicillin and Clavulanic acid tablets can degrade, leading to a loss of potency and therapeutic efficacy. Humidity control is critical during manufacturing and packaging. About the author Caterina Funaro is IMA Active Competence Center Manager and Coating Expert. References 1.

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Packaging Compounding Dosage 52

The Checkup by Singlecare

AUGUST 8, 2024

A study from 2018 confirmed its antihistamine effect in dogs. Check the drug’s packaging and label carefully before giving it to your pet. Standard Zyrtec, with no decongestants, can be given to dogs. Not only does the Zyrtec website say it’s okay to give the medication to pets, but research backs up its efficacy.

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Dosage Labelling Packaging Immunization 96

pharmaphorum

AUGUST 11, 2020

We’d like to get to a point where our treatment and prevention offering can be packaged together for the NHS – because both go hand in hand, alongside digital tools”. We’d like to get to a point where our treatment and prevention offering can be packaged together – because both go hand in hand, alongside digital tools.”.

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Packaging Communication 111

ISPE

NOVEMBER 22, 2022

From aseptic manufacturing, process development, primary packaging selection to finished goods – you will be able to gain a lot more technical experiences by speaking to colleagues in the industry. I was introduced to Women In Pharma ® in 2018 as a panelist.

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Compounding Packaging Dosage Vaccines 98

Roots Analysis

AUGUST 14, 2023

Pasted below is a donut chart, showing the regional distribution of companies offering eco-friendly packaging solutions for biopharmaceutical industry.

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Packaging 52

Pharmaceutical Technology

NOVEMBER 21, 2022

According to the report, five member companies decided to decrease their investment in Japan between 2016 and 2017, four companies changed their investment targets between 2018 and 2020, and one company lowered the priority given to Japan after 2021.

Pharmaceutical Companies 69

Pharmaceutical Companies Pharmaceutical Companies Packaging Insurance 69

The FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

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FDA Documentation Packaging Communication 75

The Happy PharmD

AUGUST 4, 2023

The physicians provided their patients with cutting-edge therapies quite often found in the literature and not necessarily in the package insert. He also had the drug’s package insert. Unfortunately, both the vials and the package insert were written entirely in the “Swiss French” language. The hospital was ahead of its time.

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Packaging Hospitals Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JULY 19, 2021

There’s no value attached to the deal – even though BioNTech is a publicly listed company – but the company said it would involve a “one-time upfront payment” for the entire package. BioNTech’s first quarter revenues came in at more than €2 billion ($2.4

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Packaging Vaccines Immunization 45

European Pharmaceutical Review

FEBRUARY 12, 2024

Having successfully recruited 380 employees since 2018, their aim is to manage retention levels of 92 – 95 percent, providing the necessary operational stability while also creating room for personal growth and development opportunities in the organisation. Since 2021, Liam Dunne is the site head of MSD Biotech in Dublin.

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Process Improvement Packaging 98

The Checkup by Singlecare

MARCH 22, 2023

In fact, a 2018 study found that, on average, Americans pay more than two-and-a-half times as much for prescription drugs as citizens of 32 other countries involved in the study. It’s no secret that prescription drugs cost more on average in the U.S. than they do anywhere else in the developed world. Are not licensed.

Health and Personal Care Stores 105

Health and Personal Care Stores Controlled Substances Dosage FDA 105

The Checkup by Singlecare

JANUARY 4, 2024

Always follow the directions on the packaging or consult a healthcare professional if you have concerns about the appropriate dosage. In an average adult, the immediate-release forms, like the capsule and liquid, are usually taken every four hours, while the extended-release tablets are typically taken every 12 hours.

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Immunization Labelling Dosage Medication Labelling 102

ISPE

MAY 11, 2023

The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. This path will be split into steps, or work packages, that contain a manageable number of improvements for the organization to take the next step on the path. Published 30 November 2018.

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Packaging Documentation Communication Data Entry 52

The Checkup by Singlecare

JANUARY 18, 2024

Start by reading the package insert, and ask your pharmacist questions if there’s anything you don’t understand. It’s essential that your healthcare provider know everything that you are taking before they prescribe Bactrim, as it can have interactions. Follow the instructions on your prescription label. Stay hydrated.

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Mayo Clinic Adverse Reactions Packaging Labelling 105

Omnicell

JANUARY 10, 2023

million doses were diverted in 2018, equal to the population of Arizona and California combined. The new cassettes for the Omnicell CSD will accommodate MicroVault® packaging for a variety of low-dose narcotic medications, including morphine, hydromorphone, and fentanyl. And according to the 2019 Drug Diversion Digest , 47.2

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Controlled Substances Omnicell Hospitals Packaging 40

Pharmaceutical Technology

MARCH 10, 2023

Based on the further deteriorating economic situation, the MoH provided a pricing resolution that reduced subsidies on a range of raw materials used for local production and packaging of medicines. The astounding impact on Lebanese drug prices means medicines received on average a 1,123% price increase between 2018–22.

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Insurance Packaging 52

Pharmaceutical Technology

NOVEMBER 21, 2022

According to the report, five member companies decided to decrease their investment in Japan between 2016 and 2017, four companies changed their investment targets between 2018 and 2020, and one company lowered the priority given to Japan after 2021.

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Pharmaceutical Companies Pharmaceutical Companies Packaging Insurance 52

The FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. or that FDA proposes can satisfy the requirements in § 4.4 much like an FDA guidance document.

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FDA Documentation Medication Dispensing Packaging 40

pharmaphorum

JUNE 1, 2021

Many countries have introduced serialisation legislation which requires product identifiers to be affixed to each package to provide traceability throughout the distribution supply chain. However, traceability and security measures focused on the packaging level may not be enough to protect patients.

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Packaging Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 14, 2023

April 2018, BioPlan Associates, Rockville, MD USA, www.bioplanassociates.com Single-Use Technology Managing waste at the site level can be complex, time intensive, and a challenge with regards to storage space, logistics flows, and safety considerations.

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Packaging Communication 98

The Checkup by Singlecare

JULY 10, 2024

You’ve probably eaten seaweed as part of your favorite sushi dish before or even snacked on a package of dried seaweed from the shelf of your local health food store. Per the USDA, a typical portion of Irish sea moss contains 182 micrograms of folate, almost half of the daily recommended intake.

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Immunization Compounding Packaging Communication 85

PharmaShots

APRIL 25, 2023

Founded Year: 2018 Total Employees: ~80 Headquarters: California, United States Market Cap: $43.1M The company has pioneered the science behind RNAi therapies by developing and receiving approval for Onpattro (patisiran) in 2018, Givlaari (givosiran) in 2019, Oxlumo (lumasiran) in 2020, and Amvuttra (vutrisiran) in 2022.

HIV Treatment and Prevention Agents 40

HIV Treatment and Prevention Agents Packaging Immunization Vaccines 40

ISPE

OCTOBER 26, 2022

Tim Howard, who was Chair of the International Board from 2017–2018, helped by moderating the sessions. In addition, we took the Board on tours of Vetter’s facilities for sterile products and through all the production steps: compounding to fill-finish to automated visual inspection and secondary packaging. Thank you, Tim!

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Packaging Compounding Communication Vaccines 52

European Pharmaceutical Review

DECEMBER 21, 2022

10 Diagnostics and biologics also heavily utilise carbon-based materials as constituting building blocks, processing aids, single-use reactors, or packaging materials. Environ Sci Technol 2018, 52, 4, 1725–1734 [link]. Experiences and consequences of phasing out substances of concern in a multinational healthcare company.

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Compounding Pharmaceutical Companies Pharmaceutical Companies Packaging 97

The Thyroid Pharmacist

JANUARY 27, 2023

They usually charge by the minute or have discount session packages available. Published 2018 Apr 24. doi:10.1155/2018/1857413 [10] Mahlouji M, Alizadeh Vaghasloo M, Dadmehr M, Rezaeizadeh H, Nazem E, Tajadini H. Originally published in February 2018, this article has been revised and updated for accuracy and thoroughness.

Immunization 98

Immunization Packaging 98

ISPE

MARCH 8, 2023

The cases covered the same types of contaminants and impurities noted in Table 1: microbial contaminants, process-related im-purities, metal contaminants, packaging-related contaminants, drug cross-contamination, and an “unknown” category encompassing other contaminants associated with the manufacturing process, including those from cell culturing.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

PQA

JUNE 27, 2024

From 2018-2019, PQA convened a multistakeholder Specialty Pharmacy Turnaround Time Task Force to develop specifications for the measure concept, focused on establishing a standardized measure of the time between a specialty pharmacy receiving a new prescription for a specialty medication and the product being available for the patient (i.e.,

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Specialty Pharmacies Communication Packaging Documentation 40

The People's Pharmacy

MAY 8, 2023

“The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.” The FDA announced in November, 2018, that these pills were recalled because they contained NDEA (N-nitrosodiethylamine), another probable carcinogen.

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FDA Pharmaceutical Companies Pharmaceutical Companies Medical Schools 72

The Thyroid Pharmacist

AUGUST 19, 2022

MegaGuard and PyloGuard provide doses on the package. 2018; 28(1): 30-32. Published 2018 Jul 30. I suggest trying them individually, or using a combination of the three. For black seed oil, doses as low as one drop per day have been helpful in children, but I recommend checking with your practitioner. 39,64-67). J Diabetes Res.

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Health and Personal Care Stores Immunization Insurance Packaging 98

The Thyroid Pharmacist

DECEMBER 6, 2023

The key is to eat good fats found in fish, olive and coconut oil, and avocados; avoid bad (trans) fats, found in baked or fried goods, packaged cookies, certain cereals, and hydrogenated oils. Published 2018 Mar 20. When you eliminate processed foods from your diet, you will essentially have eliminated almost all forms of trans fats.

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Immunization Adverse Reactions Packaging Compounding 98

ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Published 12 September 2002. link] 11 Beierle, J., Cauchon, T.

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment. Published 12 September 2002. link] 11 Beierle, J., Cauchon, T.

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Documentation Dosage Packaging Communication 52

ISPE

NOVEMBER 29, 2022

Embracing the diversity of packaging materials on a multi-purpose fill/finish line for many different kinds of ready-to-use containers. nonprofit drug company Civica Rx was created in 2018 to address the problems of: Chronic shortages of essential medicines used in hospitals every day. Impact assessment of new Annex 1 for EU GMP.

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Vaccines Hospitals Packaging 98