If the FDA or a manufacturer finds that a marketed product presents a threat or a potential threat to consumer safety, that product may be recalled or sought for return to the manufacturer from its depth of distribution. The pharmaceutical manufacturer is legally bound to report serious unlabeled adverse reactions to the FDA through…
RLD: An RLD is the specific listed drug on which an ANDA applicant relies in seeking approval for its ANDA. The ANDA applicant must show, among other things, that its proposed generic drug is the same as to the RLD with respect to the active ingredient(s), dosage form, route of administration, strength, labeling and conditions…
Supplier relationship management (SRM) is a business initiative that many companies undertake to build mutually beneficial relationships with suppliers. Well-designed SRM programs help companies to increase collaboration by identifying the right suppliers with whom to partner. Supplier Relationship Management Benefits Supplier Relationship Management (SRM) Process Supplier Segmentation Methods Practical Tools To…
Pharma Supplier is a reliable source for top-quality pharmaceutical products with a wide range of options available. With excellent customer service and competitive prices, they are a trusted choice for all your pharmaceutical needs. Reliable pharma suppliers are pivotal in upholding quality and safety standards within the pharma industry. These trusted partners play a…
Pharmaceutical packaging plays a critical role in ensuring the safety and security of medications from the production line to the end user. Supply chain optimization and track & trace solutions have emerged as essential components of the pharmaceutical packaging process. These strategies help enhance supply chain visibility and efficiency, allowing manufacturers to track the…
FDA Adverse Event Reporting System (FAERS) monitors the safety of drugs & biologic products, contains reports of AE & medication errors that have been submitted to the FDA & to take appropriate action, such as updating drug labels/issuing safety communications. Bioequivalence (BE) Recommendations for Specific Products provides guidance on BE studies that helps applicants seeking…
Competitive generic therapy (CGT) and List Off-patent and Off-exclusivity are two important concepts that are often confused with each other. We will explore the main difference between these two concepts. Competitive Generic Therapy (CGT): NMT one approved drug in the active section of the Orange Book (RLD/Generic) + no unexpired patents or exclusivities listed…
Reprocessing Process repeating a crystallization step or other appropriate chemical or physical manipulation steps (e.g., distillation,filtration, chromatography, milling). Reworking Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g.,…
