Register entry
- Registered sites
- 1
- Active NDC listings
- 27
- Labeller names
- 2
- Live patents
- 0
- Countries
- 1
- Base
- Malaysia
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Novugen Pharma Sdn. Bhd. | No 27, Jalan Lengkuk Teknologi 2, Taman Teknologi Enstek Fasa 1, Bandar Baru Enstek, Negeri Sembilan 71760, Malaysia (MYS) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3017604745659304779 |
Catalogue
Drug listings by form and route
2727 active NDC listings: 27 human prescription drug. By marketing category: ANDA 27.
| Dosage form | NDCs |
|---|---|
| capsule | 10 |
| tablet, film coated | 8 |
| tablet | 7 |
| tablet, delayed release | 2 |
| Route | NDCs |
|---|---|
| oral | 27 |
| Labeller name on the listing | NDCs |
|---|---|
| novugen pharma (usa) llc | 16 |
| novugen pharma (usa) llc. | 11 |
Catalogue
Marketed products
27| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Abiraterone Acetate | abiraterone acetate | tablet, film coated, oral | 82293-001ANDA |
| Abiraterone Acetate | abiraterone acetate | tablet, film coated, oral | 82293-002ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 82293-006ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 82293-007ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 82293-008ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 82293-009ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 82293-010ANDA |
| Lenalidomide | Lenalidomide | capsule, oral | 82293-011ANDA |
| Macitentan | macitentan | tablet, film coated, oral | 82293-041ANDA |
| Midodrine Hydrochloride | Midodrine Hydrochloride | tablet, oral | 82293-003ANDA |
| Midodrine Hydrochloride | Midodrine Hydrochloride | tablet, oral | 82293-004ANDA |
| Midodrine Hydrochloride | Midodrine Hydrochloride | tablet, oral | 82293-005ANDA |
| Mycophenolic Acid | Mycophenolic Acid | tablet, delayed release, oral | 82293-012ANDA |
| Mycophenolic Acid | Mycophenolic Acid | tablet, delayed release, oral | 82293-013ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 82293-027ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 82293-028ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 82293-029ANDA |
| Sacubitril and Valsartan | Sacubitril and Valsartan | tablet, film coated, oral | 82293-040ANDA |
| Sunitinib Malate | Sunitinib Malate | capsule, oral | 82293-014ANDA |
| Sunitinib Malate | Sunitinib Malate | capsule, oral | 82293-015ANDA |
| Sunitinib Malate | Sunitinib Malate | capsule, oral | 82293-016ANDA |
| Sunitinib Malate | Sunitinib Malate | capsule, oral | 82293-017ANDA |
| everolimus | everolimus | tablet, oral | 82293-030ANDA |
| everolimus | everolimus | tablet, oral | 82293-031ANDA |
| everolimus | everolimus | tablet, oral | 82293-032ANDA |
| everolimus | everolimus | tablet, oral | 82293-033ANDA |
| pazopanib | pazopanib hydrochloride | tablet, film coated, oral | 82293-022ANDA |
Compare
Comparable companies in Malaysia
- Fulijaya Manufacturing Sdn. Bhd1 site · 7 NDC
- KRX RESOURCES SDN BHD1 site · 7 NDC
- JINGXIN GROUP (M) SDN. BHD.1 site · 2 NDC
- Wellmetech Pharmaceutical Industries SDN BHD1 site · 1 NDC
Enquiry
Common questions
- Is Novugen Pharma Sdn. Bhd. FDA approved?
- Novugen Pharma Sdn. Bhd. holds 1 FDA-registered establishment in Malaysia. 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 Novugen Pharma Sdn. Bhd.'s drugs manufactured?
- The FDA register lists Bandar Baru Enstek. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Novugen Pharma Sdn. Bhd. make?
- 27 products are listed under Novugen Pharma Sdn. Bhd. in the openFDA NDC Directory, most often as capsule; tablet, film coated; tablet. 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.