Register entry
- Registered sites
- 1
- Active NDC listings
- 4
- Live patents
- 0
- Countries
- 1
- Base
- India
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Simpex Pharma Pvt. Ltd | C-7 to C-13 & C-59 to C-64 Siggaddi Growth Center, Sigaddi, Kotdwar, Pauri Garhwal, Uttarakhand 246149, India (IND) | Finished drug manufacture | 3010165295916758275 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human otc drug. By marketing category: OTC MONOGRAPH DRUG 4.
| Dosage form | NDCs |
|---|---|
| tablet | 2 |
| tablet, chewable | 1 |
| tablet, coated | 1 |
| Route | NDCs |
|---|---|
| oral | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| simpex pharma pvt. ltd | 4 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Aluminum hydroxide and Magnesium carbonate | ALUMINUM HYDROXIDE, MAGNESIUM CARBONATE | tablet, chewable, oral | 76457-001OTC MONOGRAPH DRUG |
| SIMPEX Bisacodyl laxative | BISACODYL | tablet, coated, oral | 76457-003OTC MONOGRAPH DRUG |
| SIMPEX Guaifenesin | GUAIFENESIN | tablet, oral | 76457-004OTC MONOGRAPH DRUG |
| diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | tablet, oral | 76457-002OTC MONOGRAPH DRUG |
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Enquiry
Common questions
- Is Simpex Pharma Pvt. Ltd FDA approved?
- Simpex Pharma Pvt. Ltd holds 1 FDA-registered establishment in India. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Simpex Pharma Pvt. Ltd's drugs manufactured?
- The FDA register lists Pauri Garhwal. Registered operations: finished drug manufacture.
- What drugs does Simpex Pharma Pvt. Ltd make?
- 4 products are listed under Simpex Pharma Pvt. Ltd in the openFDA NDC Directory, most often as tablet; tablet, chewable; tablet, coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.