Register entry
- Registered sites
- 2
- Active NDC listings
- 4
- Live patents
- 0
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Active ingredient (API) manufacture2
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Smilax Laboratories Limited | Plot No.12/A, Phase III, IDA, Jeedimetla, Hyderabad, Telangana 500055, India (IND) | Active ingredient (API) manufacture | 3006251127650294866 |
| Smilax Laboratories Limited | Plot No :70, Jawaharlal Nehru Pharma City, E-Bonangi Village, Parawada (M), Visakhapatnam, Andhra Pradesh 531019, India (IND) | Active ingredient (API) manufacture | 3008772334677605764 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 4.
| Dosage form | NDCs |
|---|---|
| powder | 4 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| smilax laboratories limited | 4 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Esomeprazole Magnesium | powder | 71747-004BULK INGREDIENT |
| - | GUAIFENESIN | powder | 71747-003BULK INGREDIENT |
| - | ITRACONAZOLE | powder | 71747-002BULK INGREDIENT |
| - | OMEPRAZOLE | powder | 71747-001BULK INGREDIENT |
Neighbours
Registered in the same town
12- Matrix Pharmacorp Private LimitedHyderabad, IND; Visakhapatnam, IND · 4 sites
- GLAND PHARMA LIMITEDHyderabad, IND; Visakhapatnam, IND · 3 sites
- Viatris Inc.Hyderabad, IND · 2 sites
- Sai Life Sciences LimitedHyderabad, IND · 2 sites
- AKRON FORMULATIONS INDIA PRIVATE LIMITEDHyderabad, IND · 2 sites
- Actimus Biosciences Private LimitedVISAKHAPATNAM, IND; Visakhapatnam, IND · 2 sites
- DifGen Pharmaceuticals LLCHyderabad, IND · 2 sites
- Jeevan Scientific Technology LimitedHyderabad, IND · 2 sites
- SHODHANA LABORATORIES PRIVATE LIMITEDHyderabad, IND; Visakhapatnam, IND · 2 sites
- STARTECH LABS PRIVATE LIMITEDHyderabad, IND · 2 sites
- Sionc Pharmaceuticals Private LimitedVisakhapatnam, IND · 2 sites
- VENKAR CHEMICALS PRIVATE LIMITEDHyderabad, IND · 2 sites
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- SHILPA PHARMA LIFESCIENCES LIMITED2 sites · 40 NDC
- Teva API India Private Ltd.2 sites · 36 NDC
- Hikal Limited2 sites · 35 NDC
- Optimus Drugs Private Limited2 sites · 32 NDC
Enquiry
Common questions
- Is Smilax Laboratories Limited FDA approved?
- Smilax Laboratories Limited holds 2 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 Smilax Laboratories Limited's drugs manufactured?
- The FDA register lists Hyderabad; Visakhapatnam. Registered operations: active ingredient (API) manufacture.
- What drugs does Smilax Laboratories Limited make?
- 4 products are listed under Smilax Laboratories Limited in the openFDA NDC Directory, most often as powder. 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.