Register entry
- Registered sites
- 2
- Active NDC listings
- 28
- Labeller names
- 2
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
Analytical testing2Labelling1Finished drug manufacture2Packaging2Relabelling1Repackaging1
Sites
Registered establishments
2| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Apnar Pharma Private Limited | Block No.102, At And Post Gavasad Padra Jambusar Road, Taluka Padra, Vadodara, Gujarat 391430, India (IND) | Analytical testing, Finished drug manufacture, Packaging | 3016579947876730408 |
| APNAR PHARMA LLP | 10 LAKE DR, EAST WINDSOR, New Jersey (NJ) 08520, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging | 3011136472118530917 |
Catalogue
Drug listings by form and route
2828 active NDC listings: 19 human prescription drug, 9 human otc drug. By marketing category: ANDA 16, OTC MONOGRAPH DRUG 9, UNAPPROVED DRUG OTHER 3.
| Dosage form | NDCs |
|---|---|
| tablet | 15 |
| capsule | 4 |
| capsule, liquid filled | 2 |
| cream | 2 |
| suppository | 2 |
| tablet, film coated | 2 |
| solution | 1 |
| Route | NDCs |
|---|---|
| oral | 24 |
| rectal | 3 |
| topical | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| apnar pharma lp | 16 |
| apnar pharma lp | 12 |
Catalogue
Marketed products
28| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 24689-781ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 24689-785ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 24689-907ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 24689-921ANDA |
| Buspirone Hydrochloride | Buspirone Hydrochloride | tablet, oral | 24689-933ANDA |
| Docusate sodium | Docusate sodium | capsule, liquid filled, oral | 24689-130OTC MONOGRAPH DRUG |
| Eletriptan Hydrobromide | eletriptan hydrobromide | tablet, film coated, oral | 24689-167ANDA |
| Eletriptan Hydrobromide | eletriptan hydrobromide | tablet, film coated, oral | 24689-168ANDA |
| Guaifenesin | Guaifenesin | tablet, oral | 24689-144OTC MONOGRAPH DRUG |
| Hydrocortisone Acetate | Hydrocortisone Acetate | suppository, rectal | 24689-102UNAPPROVED DRUG OTHER |
| Hydrocortisone Acetate | Hydrocortisone Acetate | suppository, rectal | 24689-103UNAPPROVED DRUG OTHER |
| Hydroquinone cream | Hydroquinone | cream, topical | 24689-101UNAPPROVED DRUG OTHER |
| Lidocaine 5% | Lidocaine | cream, rectal, topical | 24689-124OTC MONOGRAPH DRUG |
| Magnesium Oxide | Magnesium Oxide | tablet, oral | 24689-132OTC MONOGRAPH DRUG |
| Meclizine Hydrochloride | Meclizine Hydrochloride | tablet, oral | 24689-138OTC MONOGRAPH DRUG |
| Meclizine Hydrochloride | Meclizine Hydrochloride | tablet, oral | 24689-139OTC MONOGRAPH DRUG |
| Meclizine Hydrochloride | Meclizine Hydrochloride | tablet, oral | 24689-146OTC MONOGRAPH DRUG |
| PRYIDOSTIGMINE BROMIDE | pyridostigmine bromide | solution, oral | 24689-104ANDA |
| SleepAid (Diphenhydramine HCL) | Diphenhydramine HCL | capsule, liquid filled, oral | 24689-154OTC MONOGRAPH DRUG |
| Sodium Bicarbonate | Sodium Bicarbonate | tablet, oral | 24689-137OTC MONOGRAPH DRUG |
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | capsule, oral | 24689-001ANDA |
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | capsule, oral | 24689-002ANDA |
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | capsule, oral | 24689-003ANDA |
| TERAZOSIN HYDROCHLORIDE | terazosin hydrochloride | capsule, oral | 24689-004ANDA |
| nebivolol | nebivolol hydrochloride | tablet, oral | 24689-159ANDA |
| nebivolol | nebivolol hydrochloride | tablet, oral | 24689-160ANDA |
| nebivolol | nebivolol hydrochloride | tablet, oral | 24689-161ANDA |
| nebivolol | nebivolol hydrochloride | tablet, oral | 24689-162ANDA |
Neighbours
Registered in the same town
12- Alembic Pharmaceuticals LimitedVADODARA, IND; Vadodara, IND · 4 sites
- BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LIMITEDVadodara, IND · 3 sites
- Zydus Lifesciences LimitedVadodara, IND · 2 sites
- FARMSON BASIC DRUGS PRIVATE LIMITEDVadodara, IND · 2 sites
- KLM Laboratories Private LimitedVadodara, IND · 2 sites
- Lupin LimitedVadodara, IND
- Sun Pharmaceutical Industries LimitedVadodara, IND
- Ipca Laboratories LimitedVadodara, IND
- Apicore US LLCVadodara, IND
- HOVIONE FARMACIENCIA, S.A.East Windsor, NJ
- Aurolife Pharma LLCEast Windsor, NJ
- Kumar Organic Products LimitedVadodara, IND
Compare
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- Nivagen Pharmaceuticals LLC2 sites · 106 NDC
- GOJO Industries, LLC2 sites · 84 NDC
- KVK-TECH, INC.2 sites · 71 NDC
- Revlon Consumer Products Corporation2 sites · 61 NDC
- Samsung Biologics Co., Ltd.2 sites · 57 NDC
Enquiry
Common questions
- Is Apnar Pharma Private Limited FDA approved?
- Apnar Pharma Private Limited holds 2 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 Apnar Pharma Private Limited's drugs manufactured?
- At registered sites in India, the United States. The FDA register lists Vadodara; EAST WINDSOR, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, relabelling, repackaging.
- What drugs does Apnar Pharma Private Limited make?
- 28 products are listed under Apnar Pharma Private Limited in the openFDA NDC Directory, most often as tablet; capsule; capsule, liquid filled. 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.