Register entry
- Registered sites
- 5
- Active NDC listings
- 4
- Live patents
- 15
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing5Labelling1Finished drug manufacture3Packaging3
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| SHILPA MEDICARE LIMITED | Unit-III, Plot No. 29 A5, 4th Phase, Avverhalli � Sompura Industrial Area, Dabaspet, Bengaluru, Karnataka 562111, India (IND) | Analytical testing | 3010619401650613446 |
| SHILPA MEDICARE LIMITED | Unit-VI, Plot No. 29-A5, 4th Phase, Avverhalli � Sompura Industrial Area, Dabaspet, Bengaluru, Karnataka 562111, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3018694237854193706 |
| SHILPA BIOLOGICALS PRIVATE LIMITEDRegistrant: SHILPA MEDICARE LIMITED | Plot No.: 532-A, Belur Industrial Area, Dharwad, Karnataka 580011, India (IND) | Analytical testing, Finished drug manufacture, Packaging | 3022989727861995115 |
| SHILPA MEDICARE LIMITED | Unit-VII, 1st Floor, Plot No. 79, Survey No 125, IDA Mallapur, Nacharam, Uppal,, Hyderabad, Telangana 500076, India (IND) | Analytical testing | 3019773458854248050 |
| SHILPA MEDICARE LIMITED | S-20 to S-26, Pharmaceutical Formulations SEZ; TSIIC, Green Industrial Park, Polepally, Jadcherla, Mahabubnagar, Telangana 509301, India (IND) | Analytical testing, Finished drug manufacture, Packaging | 3009876430650644136 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 human prescription drug. By marketing category: NDA 4.
| Dosage form | NDCs |
|---|---|
| injection | 4 |
| Route | NDCs |
|---|---|
| intravenous | 4 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| shilpa medicare limited | 4 |
Exclusivity
Patents and exclusivities
15| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10842770 | DOCETAXELdocetaxel | product | Aug 2031 |
| 8940786 | DOCETAXELdocetaxel | product | Sept 2033 |
| 9308195 | DOCETAXELdocetaxel | product | Sept 2033 |
| 9763880 | DOCETAXELdocetaxel | use | Sept 2033 |
| 11147817 | PEMETREXEDpemetrexed disodium | product | Mar 2035 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Bortezomib | Bortezomib | injection, intravenous, subcutaneous | 63759-3032NDA |
| Pemetrexed | Pemetrexed disodium | injection, intravenous | 63759-3048NDA |
| Pemetrexed | Pemetrexed disodium | injection, intravenous | 63759-3049NDA |
| Pemetrexed | Pemetrexed disodium | injection, intravenous | 63759-3050NDA |
Neighbours
Registered in the same town
12- Biocon Biologics LimitedBengaluru, IND · 5 sites
- Micro Labs LimitedBengaluru, IND · 4 sites
- Viatris Inc.Bengaluru, IND; Hyderabad, IND · 3 sites
- Hetero Labs LimitedHyderabad, IND; Mahabubnagar, IND · 3 sites
- Syngene International LimitedBengaluru, IND · 3 sites
- CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
- Matrix Pharmacorp Private LimitedHyderabad, IND · 2 sites
- GLAND PHARMA LIMITEDHyderabad, IND · 2 sites
- Sai Life Sciences LimitedHyderabad, IND · 2 sites
- Anthem Biosciences LimitedBengaluru, IND · 2 sites
- ONESOURCE SPECIALTY PHARMA LIMITEDBengaluru, IND · 2 sites
- ScieGen Pharmaceuticals India Private LimitedHyderabad, IND; Mahabubnagar, IND · 2 sites
Compare
Comparable companies in India
- Macleods Pharmaceuticals Limited5 sites · 390 NDC
- Unichem Laboratories Limited, India5 sites · 272 NDC
- Strides Pharma Science Limited5 sites · 230 NDC
- Par Health USA, LLC5 sites · 211 NDC
- Torrent Pharma, Inc.5 sites · 184 NDC
- Micro Labs Limited5 sites · 141 NDC
- Matrix Pharmacorp Private Limited5 sites · 122 NDC
- NATCO PHARMA LIMITED5 sites · 108 NDC
- LAURUS LABS LIMITED5 sites · 87 NDC
- Encube Ethicals Limited5 sites · 77 NDC
Enquiry
Common questions
- Is SHILPA MEDICARE LIMITED FDA approved?
- SHILPA MEDICARE LIMITED holds 5 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 SHILPA MEDICARE LIMITED's drugs manufactured?
- The FDA register lists Bengaluru; Dharwad; Hyderabad; Mahabubnagar. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does SHILPA MEDICARE LIMITED make?
- 4 products are listed under SHILPA MEDICARE LIMITED in the openFDA NDC Directory, most often as injection. 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.