Register entry
- Registered sites
- 5
- Active NDC listings
- 4
- Labeller names
- 2
- Live patents
- 0
- Countries
- 2
- Base
- India
Authorisation
Registered operations
Analytical testing5Active ingredient (API) manufacture4Finished drug manufacture4
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| SYNGENE INTERNATIONAL LIMITEDRegistrant: Syngene International Limited | Biocon SEZ, Biocon Park, Plot No. 2, 3, 4 & 5, Bommasandra Industrial Area, Jigani Link Road, Bengaluru, Karnataka 560099, India (IND) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3003600340915833842 |
| SYNGENE INTERNATIONAL LIMITEDRegistrant: Syngene International Limited | Unit 3, No: 68/A, Bommasandra Industrial Area, I Phase, Hosur Road, Anekal, Bengaluru, Karnataka 560099, India (IND) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3035152598756130437 |
| Syngene International Limited | Plot No. 31, Clinical Development, Tower 1, Semicon Park, Bengaluru, Karnataka 560100, India (IND) | Analytical testing | 3007907068918278532 |
| Syngene International Limited | MSEZ, Plot No. IP-39, IP-46 & IP-60, IP-25 (Part) & IP-61 (Part) Kalavar Village & Post, Dakshina Kannada, Mangaluru, Karnataka 574142, India (IND) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3012608389854220603 |
| Syngene USA Inc. | 5901 East Lombard Street, Baltimore, Maryland (MD) 21224, United States (USA) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3015448605144834631 |
Catalogue
Drug listings by form and route
44 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 4.
| Dosage form | NDCs |
|---|---|
| powder | 4 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| syngene international limited | 2 |
| syngene international limited | 2 |
Catalogue
Marketed products
4| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Adagrasib | powder | 84101-003BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Belinostat | powder | 84101-004BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Odevixibat Sesquihydrate | powder | 84101-002BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Posaconazole | powder | 84101-001BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
Neighbours
Registered in the same town
12- Biocon Biologics LimitedBengaluru, IND · 5 sites
- Micro Labs LimitedBengaluru, IND · 4 sites
- CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
- SHILPA MEDICARE LIMITEDBengaluru, IND · 2 sites
- Anthem Biosciences LimitedBengaluru, IND · 2 sites
- ONESOURCE SPECIALTY PHARMA LIMITEDBengaluru, IND · 2 sites
- Eurofins Advinus BioPharma Services India Private LimitedBENGALURU, IND; Bengaluru, IND · 2 sites
- Catalent Pharma Solutions Inc.Baltimore, MD
- Viatris Inc.Bengaluru, IND
- Apotex Inc.Bengaluru, IND
- Eisai Inc.Baltimore, MD
- TransOx, Inc.Baltimore, MD
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 Syngene International Limited FDA approved?
- Syngene International Limited holds 5 FDA-registered establishments across 2 countries. 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 Syngene International Limited's drugs manufactured?
- At registered sites in India, the United States. The FDA register lists Bengaluru; Mangaluru; Baltimore, MD. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Syngene International Limited make?
- 4 products are listed under Syngene International 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.