Register entryShortage reported
ONESOURCE SPECIALTY PHARMA LIMITED
Data as of · How to read this entry
- Registered sites
- 3
- Active NDC listings
- 53
- Labeller names
- 2
- Live patents
- 0
- Shortage listings
- 2
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing3Labelling3Finished drug manufacture3Packaging3sterilize2
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| ONESOURCE SPECIALTY PHARMA LIMITED | Sterile Product Division, Opp IIM, Bilekahalli, Bannerghatta Road,, Bengaluru, Karnataka 560076, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3003813519676199117 |
| ONESOURCE SPECIALTY PHARMA LIMITED | Beta Lactam Division, 152/6 & 154/16, Doresanipalya, Bilekahalli, Bannerghatta Road,, Bengaluru, Karnataka 560076, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3005652193650391548 |
| ONESOURCE SPECIALTY PHARMA LIMITED | Plot no.: 2-D1, Obadenahalli Industrial Area, Doddaballapura, 3rd Phase, Kasa, Doddaballapura Taluk, Bengaluru Rural, Karnataka 561203, India (IND) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3017501030867530307 |
Alert
Drug shortage listings
2| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Bupivacaine Hydrochloride InjectionAnesthesia | Bupivacaine Hydrochloride PRESERVATIVE FREE, Injection, 2.5 mg/1 mL 5mg / 1mL (NDC 72266-263-10) | Current | Available | 20 Feb 201818 Sept 2026 |
| Bupivacaine Hydrochloride InjectionAnesthesia | Bupivacaine Hydrochloride PRESERVATIVE FREE, Injection, 2.5 mg/1 mL (NDC 72266-263-10) | Current | Available | 20 Feb 20185 Sept 2026 |
Catalogue
Drug listings by form and route
5353 active NDC listings: 53 human prescription drug. By marketing category: ANDA 52, NDA 1.
| Dosage form | NDCs |
|---|---|
| injection, solution | 22 |
| injection, powder, for solution | 15 |
| injection | 11 |
| injection, powder, lyophilized, for solution | 4 |
| capsule | 1 |
| Route | NDCs |
|---|---|
| intravenous | 37 |
| intramuscular | 27 |
| epidural | 6 |
| infiltration | 4 |
| subcutaneous | 4 |
| retrobulbar | 2 |
| oral | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| onesource specialty pharma limited | 33 |
| onesource specialty pharma limited | 20 |
Catalogue
Marketed products
53| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Acetylcysteine | Acetylcysteine | injection, solution, intravenous | 83270-001ANDA |
| Ampicillin | Ampicillin | injection, powder, for solution, intramuscular, intravenous | 83270-311ANDA |
| Ampicillin | Ampicillin | injection, powder, for solution, intramuscular, intravenous | 83270-312ANDA |
| Ampicillin | Ampicillin | injection, powder, for solution, intramuscular, intravenous | 83270-313ANDA |
| Ampicillin | Ampicillin | injection, powder, for solution, intravenous | 83270-314ANDA |
| Ampicillin | Ampicillin | injection, powder, for solution, intravenous | 83270-315ANDA |
| Ampicillin Sodium and Sulbactam Sodium | ampicillin sodium, sulbactam sodium | injection, powder, for solution, intramuscular, intravenous | 83270-308ANDA |
| Bupivacaine Hydrochloride | Bupivacaine Hydrochloride | injection, solution, epidural, infiltration | 83270-162ANDA |
| Bupivacaine Hydrochloride | Bupivacaine Hydrochloride | injection, solution, epidural | 83270-163ANDA |
| Bupivacaine Hydrochloride | Bupivacaine Hydrochloride | injection, solution, epidural, retrobulbar | 83270-164ANDA |
| Bupivacaine Hydrochloride | Bupivacaine Hydrochloride | injection, solution, epidural, infiltration | 83270-165ANDA |
| Bupivacaine Hydrochloride | Bupivacaine Hydrochloride | injection, solution, epidural | 83270-166ANDA |
| Bupivacaine Hydrochloride | Bupivacaine Hydrochloride | injection, solution, epidural, retrobulbar | 83270-167ANDA |
| Bupivacaine Hydrochloride | bupivacaine hydrochloride | injection, solution, infiltration | 83270-168ANDA |
| Bupivacaine Hydrochloride | bupivacaine hydrochloride | injection, solution, infiltration | 83270-169ANDA |
| Carboprost Tromethamine | Carboprost Tromethamine | injection, solution, intramuscular | 83270-002ANDA |
| ETOPOSIDE | ETOPOSIDE | capsule, oral | 83270-451NDA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | injection, intramuscular, intravenous | 83270-153ANDA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | injection, intramuscular, intravenous | 83270-154ANDA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | injection, intramuscular | 83270-155ANDA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | injection, intramuscular, intravenous | 83270-157ANDA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | injection, intramuscular, intravenous | 83270-158ANDA |
| KETOROLAC TROMETHAMINE | KETOROLAC TROMETHAMINE | injection, intramuscular | 83270-159ANDA |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | injection, intravenous | 83270-178ANDA |
| LABETALOL HYDROCHLORIDE | LABETALOL HYDROCHLORIDE | injection, intravenous | 83270-179ANDA |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | injection, powder, lyophilized, for solution, intravenous | 83270-006ANDA |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | injection, powder, lyophilized, for solution, intravenous | 83270-007ANDA |
| Levothyroxine Sodium | LEVOTHYROXINE SODIUM ANHYDROUS | injection, powder, lyophilized, for solution, intravenous | 83270-008ANDA |
| Methohexital Sodium | Methohexital Sodium | injection, intravenous | 83270-003ANDA |
| Midazolam | midazolam hydrochloride | injection, solution, intramuscular, intravenous | 83270-170ANDA |
| Midazolam | midazolam hydrochloride | injection, solution, intramuscular, intravenous | 83270-171ANDA |
| Midazolam | midazolam hydrochloride | injection, solution, intramuscular, intravenous | 83270-172ANDA |
| Midazolam | midazolam hydrochloride | injection, solution, intramuscular, intravenous | 83270-173ANDA |
| Midazolam | midazolam hydrochloride | injection, solution, intramuscular, intravenous | 83270-174ANDA |
| Midazolam | midazolam hydrochloride | injection, solution, intramuscular, intravenous | 83270-175ANDA |
| Midazolam | midazolam hydrochloride | injection, solution, intramuscular, intravenous | 83270-176ANDA |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | injection, powder, for solution, intramuscular, intravenous | 83270-309ANDA |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | injection, powder, for solution, intramuscular, intravenous | 83270-310ANDA |
| Thiamine Hydrochloride | Thiamine Hydrochloride | injection, solution, intramuscular, intravenous | 83270-004ANDA |
| ampicillin sodium and sulbactam sodium | ampicillin sodium and sulbactam sodium | injection, powder, for solution, intramuscular, intravenous | 83270-304ANDA |
| ampicillin sodium and sulbactam sodium | ampicillin sodium and sulbactam sodium | injection, powder, for solution, intramuscular, intravenous | 83270-305ANDA |
| mycophenolate mofetil | mycophenolate mofetil | injection, powder, lyophilized, for solution, intravenous | 83270-000ANDA |
| ondansetron hydrochloride | ondansetron hydrochloride | injection, intramuscular, intravenous | 83270-160ANDA |
| ondansetron hydrochloride | ondansetron hydrochloride | injection, intramuscular, intravenous | 83270-161ANDA |
| oxacillin | oxacillin | injection, powder, for solution, intramuscular, intravenous | 83270-306ANDA |
| oxacillin | oxacillin | injection, powder, for solution, intramuscular, intravenous | 83270-307ANDA |
| piperacillin and tazobactam | piperacillin and tazobactam | injection, powder, for solution, intravenous | 83270-301ANDA |
| piperacillin and tazobactam | piperacillin and tazobactam | injection, powder, for solution, intravenous | 83270-302ANDA |
| piperacillin and tazobactam | piperacillin and tazobactam | injection, powder, for solution, intravenous | 83270-303ANDA |
| sumatriptan | sumatriptan | injection, solution, subcutaneous | 83270-005ANDA |
| sumatriptan | sumatriptan | injection, solution, subcutaneous | 83270-151ANDA |
| sumatriptan | sumatriptan | injection, solution, subcutaneous | 83270-152ANDA |
| sumatriptan | sumatriptan | injection, solution, subcutaneous | 83270-156ANDA |
Neighbours
Registered in the same town
12- Biocon Biologics LimitedBengaluru, IND · 5 sites
- Micro Labs LimitedBengaluru, IND · 4 sites
- Syngene International LimitedBengaluru, IND · 3 sites
- CIPLA PHARMACEUTICALS LIMITEDBengaluru, IND · 2 sites
- SHILPA MEDICARE LIMITEDBengaluru, IND · 2 sites
- Anthem Biosciences LimitedBengaluru, IND · 2 sites
- Eurofins Advinus BioPharma Services India Private LimitedBENGALURU, IND; Bengaluru, IND · 2 sites
- Viatris Inc.Bengaluru, IND
- Apotex Inc.Bengaluru, IND
- Strides Pharma Science LimitedBengaluru, IND
- Eurofins BioPharma Product Testing India Private LimitedBengaluru, IND
- R.L.Fine Chem Private LimitedBengaluru, IND
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Enquiry
Common questions
- Is ONESOURCE SPECIALTY PHARMA LIMITED FDA approved?
- ONESOURCE SPECIALTY PHARMA 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 ONESOURCE SPECIALTY PHARMA LIMITED's drugs manufactured?
- The FDA register lists Bengaluru; Bengaluru Rural. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does ONESOURCE SPECIALTY PHARMA LIMITED make?
- 53 products are listed under ONESOURCE SPECIALTY PHARMA LIMITED in the openFDA NDC Directory, most often as injection, solution; injection, powder, for solution; injection. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any ONESOURCE SPECIALTY PHARMA LIMITED products in shortage?
- 2 presentations are currently listed in the FDA drug shortage database under ONESOURCE SPECIALTY PHARMA LIMITED, covering Bupivacaine Hydrochloride Injection.
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.