Register entry
Mayne Pharma International Pty Ltd.
- Registered sites
- 1
- Drug products
- 64
- Live patents
- 154
- Countries
- 1
- Base
- Australia
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingLabellingFinished drug manufacturePackaging
Sites
Facilities
1| Site | Location | Operations | FEI |
|---|---|---|---|
| Mayne Pharma International Pty Ltd. | Salisbury SouthAustralia | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3004090027 |
Exclusivity
Patents
154Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| ANNOVERA | ETHINYL ESTRADIOL; SEGESTERONE ACETATE | Feb 2039 |
| ANNOVERA | ETHINYL ESTRADIOL; SEGESTERONE ACETATE | Jun 2039 |
| BIJUVA | ESTRADIOL; PROGESTERONE | Nov 2032 |
| DORYX | DOXYCYCLINE HYCLATE | Feb 2028 |
| DORYX MPC | DOXYCYCLINE HYCLATE | Feb 2028 |
| DORYX MPC | DOXYCYCLINE HYCLATE | Oct 2034 |
| DORYX MPC | DOXYCYCLINE HYCLATE | Dec 2034 |
| EPSOLAY | BENZOYL PEROXIDE | Feb 2028 |
| EPSOLAY | BENZOYL PEROXIDE | Aug 2028 |
| EPSOLAY | BENZOYL PEROXIDE | Nov 2032 |
| EPSOLAY | BENZOYL PEROXIDE | Feb 2040 |
| EPSOLAY | BENZOYL PEROXIDE | Aug 2040 |
| EPSOLAY | BENZOYL PEROXIDE | Dec 2040 |
| EPSOLAY | BENZOYL PEROXIDE | May 2041 |
| FABIOR | TAZAROTENE | Feb 2030 |
| IMVEXXY | ESTRADIOL | Nov 2032 |
| IMVEXXY | ESTRADIOL | Feb 2034 |
| LEXETTE | HALOBETASOL PROPIONATE | Nov 2036 |
| LEXETTE | HALOBETASOL PROPIONATE | May 2037 |
| NEXTSTELLIS | DROSPIRENONE; ESTETROL | Jan 2028 |
| NEXTSTELLIS | DROSPIRENONE; ESTETROL | Jun 2036 |
| NEXTSTELLIS | DROSPIRENONE; ESTETROL | Feb 2043 |
| NEXTSTELLIS | DROSPIRENONE; ESTETROL | Oct 2043 |
| RHOFADE | OXYMETAZOLINE HYDROCHLORIDE | May 2028 |
| RHOFADE | OXYMETAZOLINE HYDROCHLORIDE | Dec 2031 |
| RHOFADE | OXYMETAZOLINE HYDROCHLORIDE | Jun 2035 |
| SORILUX | CALCIPOTRIENE | May 2028 |
| TOLSURA | ITRACONAZOLE | Jun 2033 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | Feb 2028 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | Aug 2028 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | Dec 2030 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | Jun 2032 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | Jul 2038 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | Dec 2040 |
| TWYNEO | BENZOYL PEROXIDE; TRETINOIN | May 2041 |
Catalogue
Marketed products
64Showing 64 of 64.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Annovera | segesterone acetate and ethinyl estradiol | RING | NDA |
| Azurette | desogestrel/ethinyl estradiol and ethinyl estradiol | KIT | ANDA |
| - | Budesonide | CAPSULE, DELAYED RELEASE PELLETS | DRUG FOR FURTHER PROCESSING |
| CAMILA | NORETHINDRONE | TABLET | ANDA |
| - | Carbidopa and Levodopa | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Carbidopa and Levodopa | TABLET | DRUG FOR FURTHER PROCESSING |
| - | Carbidopa and Levodopa | TABLET | DRUG FOR FURTHER PROCESSING |
| Clindamycin Phosphate and Benzoyl Peroxide | Clindamycin Phosphate and Benzoyl Peroxide | GEL | ANDA |
| Clonidine | CLONIDINE | PATCH, EXTENDED RELEASE | ANDA |
| DOXYCYCLINE | DOXYCYCLINE | CAPSULE | NDA AUTHORIZED GENERIC |
| Dapsone | Dapsone | GEL | ANDA |
| Desogestrel and Ethinyl Estradiol | Desogestrel and Ethinyl Estradiol | KIT | ANDA |
| - | Diltiazem Hydrochloride | CAPSULE, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | Diltiazem Hydrochloride | CAPSULE, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | Diltiazem Hydrochloride | CAPSULE, EXTENDED RELEASE | DRUG FOR FURTHER PROCESSING |
| ERRIN | NORETHINDRONE | TABLET | ANDA |
| FABIOR | tazarotene | AEROSOL, FOAM | NDA |
| FLUOROURACIL | FLUOROURACIL | CREAM | ANDA |
| Halobetasol propionate | Halobetasol propionate | AEROSOL, FOAM | ANDA |
| IVERMECTIN | IVERMECTIN | CREAM | NDA AUTHORIZED GENERIC |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| Isotretinoin | Isotretinoin | CAPSULE, LIQUID FILLED | ANDA |
| - | Itraconazole | CAPSULE, GELATIN COATED | DRUG FOR FURTHER PROCESSING |
| LEXETTE | halobetasol propionate | AEROSOL, FOAM | ANDA |
| Levora | levonorgestrel and ethinyl estradiol | KIT | ANDA |
| Low-Ogestrel | Norgestrel and Ethinyl Estradiol | KIT | ANDA |
| Lutera | levonorgestrel and ethinyl estradiol | KIT | ANDA |
| METRONIDAZOLE | METRONIDAZOLE | CREAM | NDA AUTHORIZED GENERIC |
| Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride (LA) | Methylphenidate Hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Metronidazole | metronidazole | GEL | NDA AUTHORIZED GENERIC |
| Microgestin 1.5/30 | Norethindrone Acetate/Ethinyl Estradiol | KIT | ANDA |
| Microgestin 1/20 | Norethindrone Acetate/Ethinyl Estradiol | KIT | ANDA |
| Microgestin 24 Fe | Norethindrone acetate/Ethinyl Estradiol and Ferrous Fumarate | KIT | ANDA |
| Microgestin Fe 1.5/30 | Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate | KIT | ANDA |
| Microgestin Fe 1/20 | Norethindrone Acetate/Ethinyl Estradiol and Ferrous Fumarate | KIT | ANDA |
| Necon | norethindrone and ethinyl estradiol | KIT | ANDA |
| Nextstellis | drospirenone and estetrol | KIT | NDA |
| Nortriptyline Hydrochloride | Nortriptyline Hydrochloride | CAPSULE | ANDA |
| Nymyo | norgestimate and ethinyl estradiol | KIT | ANDA |
| Rhofade | oxymetazoline hydrochloride | CREAM | NDA |
| Rhofade | oxymetazoline hydrochloride | CREAM | NDA |
| SOLTAMOX | TAMOXIFEN CITRATE | LIQUID | NDA |
| SORILUX | calcipotriene | AEROSOL, FOAM | NDA |
| SRONYX | Levonorgestrel and Ethinyl Estradiol | KIT | ANDA |
| Tazarotene | TAZAROTENE | CREAM | ANDA |
| Tilia Fe | NdAc and EE Tablets and Ferrous Fumarate Tablets | KIT | ANDA |
| Tretinoin (Microsphere) | tretinoin | GEL | ANDA |
| Tri-Nymyo | Norgestimate and Ethinyl Estradiol | KIT | ANDA |
| Zovia 1/35 | Ethynodiol Diacetate and Ethinyl Estradiol Tablets | KIT | ANDA |
| adapalene and benzoyl peroxide | adapalene and benzoyl peroxide | GEL | NDA AUTHORIZED GENERIC |
| butalbital, acetaminophen and caffeine | butalbital, acetaminophen and caffeine | CAPSULE | ANDA |
| calcipotriene | calcipotriene | AEROSOL, FOAM | NDA |
| clobetasol propionate | clobetasol propionate | SHAMPOO | NDA AUTHORIZED GENERIC |
| - | doxycycline hyclate | TABLET, DELAYED RELEASE | DRUG FOR FURTHER PROCESSING |
| - | erythromycin | CAPSULE, DELAYED RELEASE PELLETS | DRUG FOR FURTHER PROCESSING |
| metronidazole | metronidazole | LOTION | NDA AUTHORIZED GENERIC |
| tazarotene | tazarotene | AEROSOL, FOAM | NDA AUTHORIZED GENERIC |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.