Antibiotic Razgrad AD sell "Azithromycin ABR"
Basic Information
60
2
1
3.4(6)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Product Name
Azithromycin ABR
Details
Manufacturer(s)
Specifications
- Content Uniformity: Meets compendial content-uniformity limits (typically 85.0-115.0% of label claim, AV ≤ 15)
- Capsule Fill Weight: Fill weight controlled within ± 10% of target per capsule, verified by in-process weight checks
- Disintegration Time: Disintegrates within compendial time limits (typically ≤ 30 minutes) in simulated gastric fluid
Other Information
Additional Description:
Azithromycin ABR is supplied as 500 mg capsules in blister strips of 3 or 6, with a 3-year shelf life, produced in batches of 75,000 capsules, marketing authorization already in place, and dossier available in eCTD format.
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