Antibiotic Razgrad AD sell "Aciclovir ABR"
Basic Information
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Subcategory & Sub-subcategory
Trade Type
Sell
Product Name
Aciclovir ABR
Details
Manufacturer(s)
Specifications
- Container Closure Integrity: Primary packaging (bottle, blister, tube, vial, or ampoule as applicable) is validated to maintain seal integrity and protect product stability throughout the shelf life.
- Sterility: Manufactured as a non-sterile product, in line with standard practice for this dosage form; microbial limits controlled per pharmacopeial requirements (e.g., USP <61>/<62>, Ph. Eur. 2.6.12/2.6.13).
- Content Uniformity: Meets pharmacopeial content-uniformity acceptance criteria (USP <905> / Ph. Eur. 2.9.40); active ingredient uniformly distributed across dosage units.
Other Information
Additional Description:
Aciclovir ABR is a cream formulation at 50 mg/g strength, packaged in 5 g tubes with a 2-year shelf life and a 6,000-tube batch size. Marketing authorization is available, with an eCTD dossier.
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