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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

Additionally, ANDA submissions should extrapolate the RLD safety and effectiveness data for drugs with the same active ingredients, dosage forms, strengths, routes, and labeling. In 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new. What is drug dose optimisation?

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Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale manufacturing capabilities

Pharmaceutical Technology

Pharmaceutical companies are looking to paediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. Various modifications to adult dosage forms (ADFs) are often needed to make a drug easier for children to take and easier for parents to administer. Innovative solutions to complex challenges.

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Leading pharmaceutical solid dose (commercial dose) manufacturing companies in contract marketing

Pharmaceutical Technology

Pharmaceutical solid dose manufacturing companies in contract marketing segment have gained a vital position in pharmaceutical formulations. Pharmaceutical solid dosage forms are the most popular in the pharmaceutical industry and are one of the most used drug delivery methods across patient groups.

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Understanding both the significant competitive advantages that FDC products can offer, and the difficulties and potential pitfalls associated with development and manufacturing of FDC drugs in oral solid dosage forms is a critical first step for companies exploring this approach. Of those 131 approved FDCs, 98 were oral dosage forms.

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Leading commercial dose companies in contract marketing

Pharmaceutical Technology

Commercial dose companies form a critical component of the pharmaceutical manufacturing industry’s value chain. The dose form manufacturing follows API manufacturing to produce the final dosage form (FDF such as tablets and injectables. Contract marketing of commercial doses.

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Leading pharmaceutical compounding companies in contract marketing

Pharmaceutical Technology

Pharmaceutical compounding is a method of preparing personalised medications for patients by mixing the individual ingredients in the exact strength and dosage form required by the patient. Pharmaceutical compounding may fulfil the specific requirements of patients, unlike mass-produced medicines. Packaging. • Formulation.