| Product Information |
|
| Registration Number |
DRP-13074
|
| Generic Name |
Gemcitabine (As Hydrochloride)
|
| Brand Name |
Gemcisaph-1000
|
| Dosage Strength |
1 g
|
| Dosage Form |
Lyophilized Powder for Injection (IV Infusion)
|
| Classification |
Prescription Drug (RX)
|
| Pharmacologic Category |
Antineoplastic
|
| Packaging |
50 mL USP Type-I Glass Vial
|
| Manufacturer |
Bruck Pharma Private Limited
|
| Country of Origin |
India
|
| Trader |
|
| Importer |
Nelpa Lifesciences, Inc.
|
| Distributor |
Nelpa Lifesciences, Inc.
|
| Application Type |
Initial
|
| Issuance Date |
28 November 2022
|
| Expiry Date |
28 November 2027
|