
CATEGORY : Allopathy
SUB CATEGORY : Tablets
SUB SUB CATEGORY : Chewable , Lozenges , Pastilles
STRENGTH : 500+5
PHARMACOPOEIAL STATUS : -
LABEL CLAIM : 500+5
MARKET : Domestic & Export
Brand Name (If already marketed) | C-MUNO + |
Mfg. Formula (Qualitative / Quantative) | Avaliable |
Brief manufacturing process (Flow chart) | Avaliable |
Manufacturing cycle time (Mfg lead time) | 15 |
Minimum & Maximum commercial batch size | 10000 Bottles - 10,00,000 Bottles |
Annual capacity | |
List of Equipment's | Avaliable |
Process Validation Report for review (In case PV already completed) | Avaliable |
Process controls (CPP) | Avaliable |
Executed BMR and BPR for review | Avaliable |
Stability data in final pack (Long Term/intermediate/Accelerated) | |
B.Size of stability batches | |
B.Size Scale-Up capacity | |
In-vitro release profile : (If applicable) | Avaliable |
Innovator or Competitor Brand name (Used as reference) | Avaliable |
Media-1 (Field) | |
Media-2 (Field) | |
Media-3 (Field) | |
Media-4 (Field) | |
Media-5 (Field) | |
BE / CT study report (If applicable) | Avaliable |
Scale Up and Process Validation report | Avaliable |
MSDS | Avaliable |
Shelf life of the product in company letterhead | Avaliable |
Vendor details for Active Ingredients | Avaliable |
Pharmacopoeial status | |
Specification (s) | Avaliable |
Valid Reference standard/Working standard availability with CoA | Avaliable |
Valid Impurity standard availability with CoA | Avaliable |
Critical Quality Attribute (If any) | Avaliable |
Excipient vendor details | Avaliable |
Active Ingredients Specification | Avaliable |
Excipients Specification | Avaliable |
In-process / Bulk Specification | Avaliable |
Finished Product Specification | Avaliable |
Shelf Life Specification | Avaliable |
Active Ingredients Method Of Analysis | Avaliable |
Excipients Method Of Analysis | Avaliable |
In-process / Bulk Method Of Analysis | Avaliable |
Finished Product Method Of Analysis | Avaliable |
Shelf Life Method Of Analysis | Avaliable |
Three batch samples (Acc/Near Exp/Fresh)in final pack (Equivalent of two times of complete analysis) | Avaliable |
If Partner / Customer want to do joint analysis, will you provide suitable dates? | Avaliable |
Blend / Bulk Assay Method | Avaliable |
FP / Stability Assay Method | Avaliable |
Related Substances (Impurities) | Avaliable |
Uniformity Of Dosage Units | Avaliable |
Dissolution | Avaliable |
Res Solv (OVI) | Avaliable |
Preservative content | |
Heavy metals | Avaliable |
Identification Test | Avaliable |
Others (If any) | Avaliable |
Manufacturing license with validity | Avaliable |
Manufacturing license number | Avaliable |
Location license (form 25, form 28 In case of India) | Avaliable |
Stability Data | Avaliable |
Long Term Stability Data (In Months) | |
Accelerated Stability Data (In Months) |
If Partner / Customer want to do Quality and Facility audit, will you provide suitable dates? | Avaliable |
Launch period of the product (Lead Time) |
Generic Name | Avaliable |
Dosage form | Avaliable |
Label Claim (With special ingredients if added in the formulation) | Avaliable |
Colours | Avaliable |
Details of pack- Pack size and Type of pack | Avaliable |
Warning as per DCGI | Avaliable |
Directions for use if any | Avaliable |
Storage condition and shelf life | Avaliable |
Special warning if any | Avaliable |
Packing material: Layouts, mock-ups (Sales and PS), leaflet in editable form. | Avaliable |
Mfg. Address | Avaliable |
Any other text matter for printing | Avaliable |
List of approved vendors | Avaliable |
Any Other Details : (Except above mentioned) |
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