Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 88
- Live patents
- 0
- Shortage listings
- 8
- Countries
- 1
- Base
- India
Authorisation
Registered operations
Analytical testing1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| CAPLIN STERILES LIMITED | SURVEY No.895 & 897. GURUVARAJAKANDIGAI, SIRUPUZHALPETTAI (POST), THIRUVALLUR (DISTRICT), GUMMIDIPOONDI, TAMIL NADU 601201, India (IND) | Analytical testing, Finished drug manufacture, Packaging | 3005035920650744670 |
Alert
Drug shortage listings
8| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Etomidate InjectionAnesthesia | Etomidate, Injection, 2 mg/mL (NDC 72485-508-10) | Current | Available | 5 Oct 202216 Jun 2026 |
| Etomidate InjectionAnesthesia | Etomidate, Injection, 2mg/1 mL (NDC 65219-445-10) | Current | Available | 5 Oct 202216 Jun 2026 |
| Etomidate InjectionAnesthesia | Etomidate, Injection, 2 mg/mL (NDC 72485-509-10) | Current | Available | 5 Oct 202216 Jun 2026 |
| Etomidate InjectionAnesthesia | Etomidate, Injection, 2mg/mL (NDC 65219-447-20) | Current | Available | 5 Oct 202216 Jun 2026 |
| Ropivacaine Hydrochloride InjectionAnesthesia | Ropivacaine Hydrochloride, Injection, 10 mg/1 mL (NDC 43066-027-10) | Current | Available | 22 Dec 202010 Jun 2026 |
| Ropivacaine Hydrochloride InjectionAnesthesia | Ropivacaine Hydrochloride, Injection, 2 mg/1 mL (NDC 43066-015-10) | Current | Limited Availability | 22 Dec 202010 Jun 2026 |
| Ropivacaine Hydrochloride InjectionAnesthesia | Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 43066-019-10) | Current | Available | 22 Dec 202010 Jun 2026 |
| Ropivacaine Hydrochloride InjectionAnesthesia | Ropivacaine Hydrochloride, Injection, 5 mg/1 mL (NDC 43066-023-10) | Current | Limited Availability | 22 Dec 202010 Jun 2026 |
Catalogue
Drug listings by form and route
8888 active NDC listings: 88 human prescription drug. By marketing category: ANDA 88.
| Dosage form | NDCs |
|---|---|
| injection | 32 |
| injection, solution | 32 |
| solution/ drops | 10 |
| solution | 7 |
| injection, solution, concentrate | 3 |
| injection, suspension | 2 |
| emulsion | 1 |
| injection, emulsion | 1 |
| Route | NDCs |
|---|---|
| intravenous | 56 |
| intramuscular | 18 |
| ophthalmic | 16 |
| epidural | 6 |
| infiltration | 5 |
| perineural | 3 |
| auricular (otic) | 2 |
| intra-articular | 2 |
| intralesional | 2 |
| soft tissue | 2 |
| subcutaneous | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| caplin steriles limited | 88 |
Catalogue
Marketed products
88| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ARGATROBAN | Argatroban | injection, intravenous | 65145-126ANDA |
| Acetaminophen | Acetaminophen | injection, solution, intravenous | 65145-157ANDA |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | solution, ophthalmic | 65145-162ANDA |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | solution, ophthalmic | 65145-163ANDA |
| Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution | Brimonidine Tartrate and Timolol Maleate | solution, ophthalmic | 65145-164ANDA |
| CARBOPROST TROMETHAMINE | carboprost tromethamine | injection, solution, intramuscular | 65145-132ANDA |
| Calcium Gluconate | Calcium Gluconate | injection, solution, intravenous | 65145-170ANDA |
| Calcium Gluconate | Calcium Gluconate | injection, solution, intravenous | 65145-171ANDA |
| Calcium Gluconate | Calcium Gluconate | injection, solution, intravenous | 65145-172ANDA |
| Cisatracurium besylate | Cisatracurium besylate | injection, intravenous | 65145-135ANDA |
| Cisatracurium besylate | Cisatracurium besylate | injection, intravenous | 65145-136ANDA |
| Cisatracurium besylate | Cisatracurium besylate | injection, intravenous | 65145-137ANDA |
| Desmopressin Acetate | Desmopressin Acetate | injection, solution, intravenous | 65145-183ANDA |
| Desmopressin Acetate | Desmopressin Acetate | injection, solution, intravenous | 65145-184ANDA |
| Difluprednate | Difluprednate | emulsion, ophthalmic | 65145-161ANDA |
| Ephedrine Sulfate | Ephedrine Sulfate | injection, intravenous | 65145-158ANDA |
| Etomidate | Etomidate | injection, solution, intravenous | 65145-127ANDA |
| Etomidate | Etomidate | injection, solution, intravenous | 65145-128ANDA |
| Foscarnet Sodium | Foscarnet Sodium | injection, solution, intravenous | 65145-191ANDA |
| Gatifloxacin Ophthalmic Solution 0.5% | Gatifloxacin Ophthalmic Solution 0.5% | solution, ophthalmic | 65145-207ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, intramuscular, intravenous | 65145-102ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, intramuscular, intravenous | 65145-103ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, intramuscular, intravenous | 65145-104ANDA |
| Glycopyrrolate | Glycopyrrolate | injection, intramuscular, intravenous | 65145-105ANDA |
| Haloperidol Decanoate | Haloperidol Decanoate | injection, intramuscular | 65145-167ANDA |
| Haloperidol Decanoate | Haloperidol Decanoate | injection, intramuscular | 65145-168ANDA |
| Haloperidol Decanoate | Haloperidol Decanoate | injection, intramuscular | 65145-169ANDA |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | injection, solution, intramuscular, intravenous | 65145-145ANDA |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | injection, solution, intramuscular, intravenous | 65145-146ANDA |
| KETOROLAC TROMETHAMINE | ketorolac tromethamine | injection, solution, intramuscular | 65145-147ANDA |
| Ketorolac Tromethamine | Ketorolac Tromethamine | solution/ drops, ophthalmic | 65145-138ANDA |
| Ketorolac Tromethamine | Ketorolac Tromethamine | solution/ drops, ophthalmic | 65145-139ANDA |
| Ketorolac Tromethamine | Ketorolac Tromethamine | solution/ drops, ophthalmic | 65145-140ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | injection, solution, intravenous | 65145-124ANDA |
| Labetalol Hydrochloride | Labetalol Hydrochloride | injection, solution, intravenous | 65145-125ANDA |
| Levetiracetam | Levetiracetam in Sodium Chloride | injection, intravenous | 65145-173ANDA |
| Levetiracetam | Levetiracetam in Sodium Chloride | injection, intravenous | 65145-174ANDA |
| Levetiracetam | Levetiracetam in Sodium Chloride | injection, intravenous | 65145-175ANDA |
| Linezolid | linezolid | injection, solution, intravenous | 65145-181ANDA |
| Methylprednisolone Acetate | Methylprednisolone Acetate | injection, suspension, intra-articular, intralesional, intramuscular, soft tissue | 65145-192ANDA |
| Methylprednisolone Acetate | Methylprednisolone Acetate | injection, suspension, intra-articular, intralesional, intramuscular, soft tissue | 65145-193ANDA |
| Milrinone Lactate | Milrinone Lactate | injection, solution, intravenous | 65145-120ANDA |
| Milrinone Lactate | Milrinone Lactate | injection, solution, intravenous | 65145-121ANDA |
| Milrinone Lactate | Milrinone Lactate | injection, solution, intravenous | 65145-122ANDA |
| Milrinone Lactate in 5% Dextrose | Milrinone Lactate in 5% Dextrose | injection, solution, intravenous | 65145-176ANDA |
| Milrinone Lactate in 5% Dextrose | Milrinone Lactate in 5% Dextrose | injection, solution, intravenous | 65145-177ANDA |
| NOREPINEPHRINE BITARTRATE | norepinephrine bitartrate | injection, intravenous | 65145-133ANDA |
| Neostigmine Methylsulfate | Neostigmine Methylsulfate | injection, intravenous | 65145-111ANDA |
| Neostigmine Methylsulfate | Neostigmine Methylsulfate | injection, intravenous | 65145-112ANDA |
| Nicardipine Hydrochloride | Nicardipine Hydrochloride | injection, intravenous | 65145-197ANDA |
| Nicardipine Hydrochloride | Nicardipine Hydrochloride | injection, intravenous | 65145-198ANDA |
| Ofloxacin | Ofloxacin Ophthalmic Solution USP, 0.3% | solution/ drops, ophthalmic | 65145-141ANDA |
| Ofloxacin | Ofloxacin Ophthalmic Solution USP, 0.3% | solution/ drops, ophthalmic | 65145-142ANDA |
| Ofloxacin | Ofloxacin Otic | solution/ drops, auricular (otic) | 65145-143ANDA |
| Ofloxacin | Ofloxacin Otic solution | solution/ drops, auricular (otic) | 65145-144ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | injection, intravenous | 65145-115ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | injection, intravenous | 65145-116ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | PHENYLEPHRINE HYDROCHLORIDE | injection, intravenous | 65145-117ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | solution/ drops, ophthalmic | 65145-148ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | solution/ drops, ophthalmic | 65145-149ANDA |
| PHENYLEPHRINE HYDROCHLORIDE | phenylephrine hydrochloride | solution/ drops, ophthalmic | 65145-150ANDA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES | injection, solution, concentrate, intravenous | 65145-194ANDA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES | injection, solution, concentrate, intravenous | 65145-195ANDA |
| POTASSIUM PHOSPHATES | POTASSIUM PHOSPHATES | injection, solution, concentrate, intravenous | 65145-196ANDA |
| Phytonadione | Phytonadione | injection, emulsion, intramuscular, intravenous, subcutaneous | 65145-151ANDA |
| Procainamide Hydrochloride | Procainamide Hydrochloride | injection, solution, intramuscular, intravenous | 65145-155ANDA |
| Procainamide Hydrochloride | Procainamide Hydrochloride | injection, solution, intramuscular, intravenous | 65145-156ANDA |
| Prochlorperazine Edisylate | Prochlorperazine Edisylate | injection, intramuscular, intravenous | 65145-119ANDA |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | injection, solution, intravenous | 65145-130ANDA |
| ROCURONIUM BROMIDE | ROCURONIUM BROMIDE | injection, solution, intravenous | 65145-131ANDA |
| Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | injection, epidural, infiltration, perineural | 65145-107ANDA |
| Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | injection, epidural, infiltration, perineural | 65145-108ANDA |
| Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | injection, epidural, infiltration, perineural | 65145-109ANDA |
| Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | injection, epidural | 65145-110ANDA |
| Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | injection, epidural, infiltration | 65145-165ANDA |
| Ropivacaine Hydrochloride | Ropivacaine Hydrochloride | injection, epidural, infiltration | 65145-166ANDA |
| SODIUM PHOSPHATES | SODIUM PHOSPHATES | injection, solution, intravenous | 65145-200ANDA |
| SODIUM PHOSPHATES | SODIUM PHOSPHATES | injection, solution, intravenous | 65145-201ANDA |
| SODIUM PHOSPHATES | SODIUM PHOSPHATES | injection, solution, intravenous | 65145-202ANDA |
| Sodium Nitroprusside | Sodium Nitroprusside | injection, intravenous | 65145-101ANDA |
| Sumatriptan | Sumatriptan | injection, solution, subcutaneous | 65145-118ANDA |
| Thiamine | Thiamine Hydrochloride | injection, solution, intramuscular, intravenous | 65145-129ANDA |
| Timolol Maleate | Timolol Maleate | solution, ophthalmic | 65145-152ANDA |
| Timolol Maleate | Timolol Maleate | solution, ophthalmic | 65145-153ANDA |
| Timolol Maleate | Timolol Maleate | solution, ophthalmic | 65145-154ANDA |
| Tranexamic Acid | Tranexamic Acid | injection, intravenous | 65145-106ANDA |
| Verapamil Hydrochloride | Verapamil Hydrochloride | injection, solution, intravenous | 65145-113ANDA |
| Verapamil Hydrochloride | Verapamil Hydrochloride | injection, solution, intravenous | 65145-114ANDA |
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Enquiry
Common questions
- Is CAPLIN STERILES LIMITED FDA approved?
- CAPLIN STERILES LIMITED holds 1 FDA-registered establishment 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 CAPLIN STERILES LIMITED's drugs manufactured?
- The FDA register lists GUMMIDIPOONDI. Registered operations: analytical testing, finished drug manufacture, packaging.
- What drugs does CAPLIN STERILES LIMITED make?
- 88 products are listed under CAPLIN STERILES LIMITED in the openFDA NDC Directory, most often as injection; injection, solution; solution/ drops. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any CAPLIN STERILES LIMITED products in shortage?
- 8 presentations are currently listed in the FDA drug shortage database under CAPLIN STERILES LIMITED, covering Etomidate Injection, Ropivacaine 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.