Register entry
- Registered sites
- 3
- Active NDC listings
- 12
- Labeller names
- 3
- Live patents
- 0
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture2Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Morepen Laboratories Limited | Morepen Village, Malkumajra, Baddi Nalagarh Road Baddi, Baddi, Himachal Pradesh 173205, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3006785414772653251 |
| Morepen Laboratories Limited | Village Masulkhana, P.O. Parwanoo, Solan, Himachal Pradesh 173220, India (IND) | Active ingredient (API) manufacture | 3002807612916177632 |
| Morepen Laboratories Limited | Malkumajra, Nalagarh Road, Baddi, Solan, Himachal Pradesh 173205, India (IND) | Active ingredient (API) manufacture | 3003897648858330880 |
Catalogue
Drug listings by form and route
1212 active NDC listings: 7 bulk ingredient, 4 human otc drug, 1 human prescription drug. By marketing category: BULK INGREDIENT 7, OTC MONOGRAPH DRUG 4, ANDA 1.
| Dosage form | NDCs |
|---|---|
| powder | 7 |
| tablet | 5 |
| Route | NDCs |
|---|---|
| oral | 5 |
| Labeller name on the listing | NDCs |
|---|---|
| morepen laboratories limited | 9 |
| morepen bio inc | 2 |
| morepen bio inc. | 1 |
Catalogue
Marketed products
12| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | DESLORATADINE | powder | 62993-0805BULK INGREDIENT |
| Desloratadine | Desloratadine | tablet, oral | 87717-001ANDA |
| Docusate Sodium and Sennosides | Docusate Sodium and Sennosides | tablet, oral | 62993-0002OTC MONOGRAPH DRUG |
| Docusate Sodium and Sennosides | Docusate Sodium and Sennosides | tablet, oral | 87717-502OTC MONOGRAPH DRUG |
| - | FEXOFENADINE HYDROCHLORIDE | powder | 62993-0809BULK INGREDIENT |
| - | LINAGLIPTIN | powder | 62993-0808BULK INGREDIENT |
| - | LORATADINE | powder | 62993-0801BULK INGREDIENT |
| - | LORATADINE | powder | 62993-0803BULK INGREDIENT |
| - | MONTELUKAST SODIUM | powder | 62993-0806BULK INGREDIENT |
| - | MONTELUKAST SODIUM | powder | 62993-0807BULK INGREDIENT |
| Sennosides | Sennosides | tablet, oral | 62993-0001OTC MONOGRAPH DRUG |
| Sennosides 8.6 mg | Sennosides | tablet, oral | 87717-501OTC MONOGRAPH DRUG |
Neighbours
Registered in the same town
12- Immacule Lifesciences Private LimitedSolan, IND · 2 sites
- Zydus Lifesciences LimitedSolan, IND
- Glenmark Pharmaceuticals Inc., USASolan, IND
- Alkem Laboratories LimitedBaddi, IND
- FDC LimitedSolan, IND
- Ceph Lifesciences Private LimitedSolan, IND
- Dabur India LimitedSolan, IND
- SENTISS PHARMA PRIVATE LIMITEDSolan, IND
- ALAINA HEALTHCARE PRIVATE LIMITEDBaddi, IND
- ALLIANCE FORMULATIONSSolan, IND
- MDC PHARMACEUTICALS LIMITEDSolan, IND
- PANACEA BIOTEC PHARMA LIMITEDSolan, IND
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Enquiry
Common questions
- Is Morepen Laboratories Limited FDA approved?
- Morepen Laboratories Limited holds 3 FDA-registered establishments 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 Morepen Laboratories Limited's drugs manufactured?
- The FDA register lists Baddi; Solan. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Morepen Laboratories Limited make?
- 12 products are listed under Morepen Laboratories Limited in the openFDA NDC Directory, most often as powder; tablet. 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.