Register entry
- Registered sites
- 3
- Active NDC listings
- 11
- Labeller names
- 2
- Live patents
- 0
- Countries
- 2
- Base
- India
Authorisation
Registered operations
Active ingredient (API) manufacture1Finished drug manufacture1Relabelling1Repackaging1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Apex Healthcare Limited | Plot No- 4710, 4711, 4707- A/8, 4707-A/9, Gidc Industrial Estate, Ankleshwar, Dist. - Bharuch, Ankleshwar, Gujarat 393002, India (IND) | Active ingredient (API) manufacture | 3006509185650476943 |
| APEX LABORATORIES PRIVATE LIMITED | B-23, SIDCO Pharmaceutical Complex, Alathur, Thiruporur, Kanchipuram, Tamil Nadu 603110, India (IND) | Finished drug manufacture | 3011361515918597266 |
| Apex 360 | 1435 Production Drive, Burlington, Kentucky (KY) 41005, United States (USA) | Relabelling, Repackaging | 3006358789617374934 |
Catalogue
Drug listings by form and route
1111 active NDC listings: 11 bulk ingredient. By marketing category: BULK INGREDIENT 9, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 2.
| Dosage form | NDCs |
|---|---|
| powder | 11 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| apex healthcare limited | 10 |
| apex healthcare limited | 1 |
Catalogue
Marketed products
11| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | BUPIVACAINE HCL | powder | 69617-012BULK INGREDIENT |
| - | Benzocaine | powder | 69617-007BULK INGREDIENT |
| - | Bisacodyl | powder | 69617-008BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Carbamide Peroxide | powder | 69617-015BULK INGREDIENT |
| - | DEXTROMETHORPHAN HYDROBROMIDE | powder | 69617-014BULK INGREDIENT |
| - | Lidocaine | powder | 69617-009BULK INGREDIENT |
| - | Lidocaine HCl | powder | 69617-010BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| - | Meloxicam | powder | 69617-016BULK INGREDIENT |
| - | Prilocaine | powder | 69617-011BULK INGREDIENT |
| - | Prilocaine HCl | powder | 69617-006BULK INGREDIENT |
| - | Ropivacaine Hydrochloride | powder | 69617-013BULK INGREDIENT |
Neighbours
Registered in the same town
10- Cadila Pharmaceuticals LimitedAnkleshwar, IND · 2 sites
- Lupin LimitedAnkleshwar, IND
- Sun Pharmaceutical Industries LimitedAnkleshwar, IND
- Zydus Lifesciences LimitedAnkleshwar, IND
- Glenmark Pharmaceuticals Inc., USAAnkleshwar, IND
- Cohance Lifesciences LimitedAnkleshwar, IND
- Intas Pharmaceuticals LimitedAnkleshwar, IND
- Gland Chemicals Private LimitedKanchipuram, IND
- ACUTAAS CHEMICALS LIMITEDAnkleshwar, IND
- BGP Healthcare Private LimitedAnkleshwar, IND
Compare
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- ScieGen Pharmaceuticals India Private Limited3 sites · 200 NDC
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- Neuland Laboratories Limited3 sites · 65 NDC
- ONESOURCE SPECIALTY PHARMA LIMITED3 sites · 53 NDC
- Pharmazell (India) Private Limited3 sites · 49 NDC
- USV Private Limited3 sites · 43 NDC
- Concord Biotech Limited3 sites · 42 NDC
- AARTI PHARMALABS LIMITED3 sites · 34 NDC
- R.L.Fine Chem Private Limited3 sites · 34 NDC
Enquiry
Common questions
- Is Apex Healthcare Limited FDA approved?
- Apex Healthcare Limited holds 3 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 Apex Healthcare Limited's drugs manufactured?
- At registered sites in India, the United States. The FDA register lists Ankleshwar; Kanchipuram; Burlington, KY. Registered operations: active ingredient (API) manufacture, finished drug manufacture, relabelling, repackaging.
- What drugs does Apex Healthcare Limited make?
- 11 products are listed under Apex Healthcare 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.