Portfolio - Product list
Browse through our product list.
PRODUCT
THERAPEUTIC AREA
Empagliflozin*/Metformin »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5 mg / 850 mg 5 mg / 1000 mg 12.5 mg / 850 mg 12.5 mg / 1000 mg
- REFERENCE PRODUCT: Synjardy ® (Boehringer Ingelheim)
- DOSSIER AVAILABILITY: EU: Q1 2027
Tirzepatide »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Solution for injection
- STRENGTH: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg
- REFERENCE PRODUCT: Mounjaro® (Lilly)
- DOSSIER AVAILABILITY: Q4 2032
Baricitinb* »
Allergy/Immunology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2 mg, 4 mg
- REFERENCE PRODUCT: Olumiaant® (Lilly)
- DOSSIER AVAILABILITY: EU: Q1 2027 CA: Q1 2027
Upadacitinib »
Allergy/Immunology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Prolonged - release tablets
- STRENGTH: 15 mg, 30 mg, 45 mg
- REFERENCE PRODUCT: Rinvoq® (Abbvie)
- DOSSIER AVAILABILITY: EU: Q4 2028
Fluticasone/Vilanterol* »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 92 mcg / 22 mcg 184 mcg / 22 mcg
- REFERENCE PRODUCT: Bro Ellipta® (GSK)
- DOSSIER AVAILABILITY: EU: Q2 2027 CA: Q2 2027
Umeclidinium/Vilanterol* »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 55 mcg / 22 mcg
- REFERENCE PRODUCT: Anoro Ellipta® (GSK)
- DOSSIER AVAILABILITY: EU: Q4 2027 CA: Q4 2027
Fluticasone/Umeclidinium/Vilanterol »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 100 mcg / 74.2 mcg / 62.5 mcg 200 mcg / 74.2mcg / 62.5 mcg
- REFERENCE PRODUCT: Trelegy Ellipta® (GSK)
- DOSSIER AVAILABILITY: EU: Q1 2028
Oxymetazoline OTC »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Nasal Gel
- STRENGTH: 0.25 mg/g, 0.5 mg/g
- REFERENCE PRODUCT: Oxalin® (Polpharma)
- DOSSIER AVAILABILITY: EU: Q3 2028
Xylometazoline OTC »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Nasal Gel
- STRENGTH: 0.1 mg/g, 1 mg/g
- REFERENCE PRODUCT: Otrivin® (Novartis)
- DOSSIER AVAILABILITY: EU: Q2 2027
Xylomethazoline/ Dexpanthenol OTC »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Nasal spray solution
- STRENGTH: 1.0 mg / 50 mg / ml (10ml) 0.5 mg / 50 mg / ml (10 ml)
- REFERENCE PRODUCT: Nasic® (Cassella-med)
- DOSSIER AVAILABILITY: EU: Q1 2028
Bempedoic Acid »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - Coated Tablets
- STRENGTH: 180 mg
- REFERENCE PRODUCT: Nilemdo® (Esperion, Daiichi Sankyo )
- DOSSIER AVAILABILITY: EU: Q2 2026
Bempedoic Acid /Ezitimibe »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - Coated Tablets
- STRENGTH: 180 mg / 10 mg
- REFERENCE PRODUCT: Nustendi® (Esperion, Daiichi Sankyo )
- DOSSIER AVAILABILITY: EU: Q2 2027
Bempedoic Acid/Ezitimibe/Atorvastatin »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Tablets
- STRENGTH: 180 mg / 10 mg / 10 mg 180 mg / 10 mg / 20 mg 180 mg / 10 mg / 40 mg 180 mg / 10 mg / 80 mg
- REFERENCE PRODUCT: Nustendi® (Daichii Sankyo) / Lipitor® (Pfizer)
- DOSSIER AVAILABILITY: EU: Q1 2030
Finerenone* »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - Coated Tablets
- STRENGTH: 10 mg, 20 mg
- REFERENCE PRODUCT: Kerendia® (Bayer)
- DOSSIER AVAILABILITY: EU: Q2 2027 CA: Q3 2027
Ramipril »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Tablets
- STRENGTH: 2.5 mg, 5 mg, 10 mg
- REFERENCE PRODUCT: Delix® (Sanofi)
- DOSSIER AVAILABILITY: EU: Q3 2026
Valsartan »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 40 mg, 80 mg, 160 mg, 320 mg
- REFERENCE PRODUCT: Diovan® (Novartis)
- DOSSIER AVAILABILITY: EU: Q4 2027
Valsartan/Hydrochlorothiazide »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 80 mg/12.5 mg 160 mg / 12.5 mg 160 mg / 25 mg 320 mg /12.5 mg 320 mg /25 mg
- REFERENCE PRODUCT: Codiovan® (Novartis)
- DOSSIER AVAILABILITY: EU: Q1 2028
Nusinersen* »
Short RNA (Oligonucleotide)
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Solution for injection
- STRENGTH: 12 mg / 5 ml vial (2.4 mg/ml)
- REFERENCE PRODUCT: Spinraza® (Biogen)
- DOSSIER AVAILABILITY: EU: Q2 2027**
Inclisiran »
Short RNA (Oligonucleotide)
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Solution for injection (pre-filled syringe)
- STRENGTH: 284 mg / 1.5 mL (189 mg/mL)
- REFERENCE PRODUCT: Leqvio® (Novartis)
- DOSSIER AVAILABILITY: EU: Q3 2028**
Cenobamate »
Central Nervous System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 200 mg
- REFERENCE PRODUCT: Ontozry® (SK Biopharmaceuticals)
- DOSSIER AVAILABILITY: EU: Q1 2028 MENA: Q1 2028
Cenobamate »
Central Nervous System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Oral Solution (first-in-market)
- STRENGTH: 10 mg/mL
- REFERENCE PRODUCT: Ontozry® (SK Biopharmaceuticals)
- DOSSIER AVAILABILITY: EU: Q1 2028 MENA: Q1 2028
Osilodrostat »
Endocrinology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Tablets
- STRENGTH: 1 mg, 5 mg, 10 mg
- REFERENCE PRODUCT: Istursia® (Recordati)
- DOSSIER AVAILABILITY: EU: Q2 2028
Minoxidil OTC »
Dermatology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Foam
- STRENGTH: 0.05
- REFERENCE PRODUCT: Regaine® (Johnson&Johnson)
- DOSSIER AVAILABILITY: EU: Q1 2028
Progesterone »
Gynecology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Solution for injection
- STRENGTH: 25 mg / 1.112 mL
- REFERENCE PRODUCT: Lubion® (IBSA)
- DOSSIER AVAILABILITY: EU: Q1 2029
Dapagliflozin* / Metformin »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5 mg / 850 mg 5 mg / 1000 mg
- REFERENCE PRODUCT: Xigduo® (AstraZeneca)
- DOSSIER AVAILABILITY: EU CA
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months
Dapagliflozin* »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5 mg, 10 mg
- REFERENCE PRODUCT: Forxiga® (AstraZeneca)
- DOSSIER AVAILABILITY: EU CA
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months
Empagliflozin* »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 10 mg, 25 mg
- REFERENCE PRODUCT: Jardiance® (Boehringer Ingelheim)
- DOSSIER AVAILABILITY: EU CA
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months 36 months / Do not store above 30 ºC
Linagliptin* »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5 mg
- REFERENCE PRODUCT: Trajenta® (Boehringer Ingelheim)
- DOSSIER AVAILABILITY: EU CA
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months
Orlistat »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Hard capsules
- STRENGTH: 120 mg
- REFERENCE PRODUCT: Xenical® (Roche)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: not available
- Shelf life: 24 months
Orlistat OTC »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Hard capsules
- STRENGTH: 60 mg
- REFERENCE PRODUCT: Alli® (GSK)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: not available
- Shelf life: 24 months
Sitagliptin* »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 25 mg, 50 mg, 100 mg
- REFERENCE PRODUCT: Januvia® (Merck)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months
Sitagliptin*/ Metformin »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 50 mg / 850 mg 50 mg / 1000 mg
- REFERENCE PRODUCT: Janumet® (Merck)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 24 months
Aciclovir »
Anti-infectives for systemic use
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Tablets
- STRENGTH: 200 mg, 400 mg, 800 mg
- REFERENCE PRODUCT: Zovirax® (GSK)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: not available
- Shelf life: 36 months
Apremilast* »
Antineoplastic & Immunomodulating Agents
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 10 mg, 20 mg, 30 mg
- REFERENCE PRODUCT: Otezla® (Celgene)
- DOSSIER AVAILABILITY: EU CA
- Lactose Free: Yes
- Stability: II: available IVb: not available
- Shelf life: 36 months
Apixaban* »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2.5 mg, 5 mg
- REFERENCE PRODUCT: Eliquis® (Bristol-Myers Squibb)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available IVb: available
- Shelf life: 36 months
Rivaroxaban* »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2.5 mg, 10 mg, 15 mg, 20 mg
- REFERENCE PRODUCT: Xarelto® (Bayer)
- DOSSIER AVAILABILITY: EU CA
- Lactose Free: No
- Stability: II: on-going IVb: on-going
- Shelf life: 24 months
Rivaroxaban* »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Capsules
- STRENGTH: 10 mg, 15 mg, 20 mg
- REFERENCE PRODUCT: Xarelto® (Bayer)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available
- Shelf life: 24 months
Ticagrelor* »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 60 mg, 90 mg
- REFERENCE PRODUCT: Brilique® (AstraZeneca)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months
Ramipril / Indapamide »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Hard capsules (IR dosage form)
- STRENGTH: 5 mg / 2.5 mg 10 mg / 2.5 mg 5 mg / 1.25 mg 10 mg / 1.25 mg
- REFERENCE PRODUCT: New combination
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available
- Shelf life: 36 months
Hydrochlorothiazide* »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Tablets
- STRENGTH: 12.5 mg, 25 mg, 50 mg
- REFERENCE PRODUCT: Esidrex® (Novartis)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available IVb: not available
- Shelf life: 60 months
Ramipril / Amlodipine »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Hard capsules
- STRENGTH: 5 mg / 5 mg 5 mg /10 mg 10 mg / 5 mg 10 mg / 10 mg
- REFERENCE PRODUCT: Tritace® /Ramipril (Sanofi) & Norvasc®/Amlodipine (Pfizer)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: not available
- Shelf life: 36 months
Rosuvastatin »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5 mg, 10 mg, 20 mg
- REFERENCE PRODUCT: Crestor® (AstraZeneca)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available IVa: available IVb: not available
- Shelf life: 36 months (Zone II) 12 months (Zone IVa)
Telmisartan / Amlodipine »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Bilayered Tablets
- STRENGTH: 40 mg / 5 mg 40 mg / 10 mg 80 mg / 5 mg 80 mg / 10 mg
- REFERENCE PRODUCT: Twynsta® (Boehringer Ingelheim)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months
Dimetindene »
Dermatology
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Gel
- STRENGTH: 1 mg /g (20g) 1 mg /g (30g) 1 mg /g (50g)
- REFERENCE PRODUCT: Fenistil(TM) (Novartis)
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVb: available
- Shelf life: 36 months
Tadalafil* »
Genito-Urinary System & Sex Hormones
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2.5 mg, 5 mg, 10 mg, 20 mg
- REFERENCE PRODUCT: Cialis® (Eli Lilly)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available IVb: available
- Shelf life: 48 months
Paracetamol/ Ibuprofen »
Musculoskeletal System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 500 mg / 200 mg
- REFERENCE PRODUCT: Nurofen Ultima® (Reckitt Benckiser)
- DOSSIER AVAILABILITY: EU
- Stability: II: available IVb: on-going
- Shelf life: 36 months
Dimethyl Fumarate »
Nervous System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Gastro - resistant hard capsules
- STRENGTH: 120 mg, 240 mg
- REFERENCE PRODUCT: Tecfidera® (Biogen Idec)
- DOSSIER AVAILABILITY: EU CA
- Lactose Free: Yes
- Stability: II: on-going IVb: on-going
- Shelf life: 36 months / Do not store above 30 ºC (zone II) 24 months / Do not store above 30 ºC (zone IV)
Memantine hydrochloride »
Nervous System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 10 mg, 20 mg
- REFERENCE PRODUCT: Ebixa® (Lundbeck)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available IVa: available
- Shelf life: 36 months
- STORAGE CONDITIONS: Store below 30oC. After first opening use in 90 days.
- BATCH SIZE: 43 860
- POLPHARMA'S BRAND: Olodon® free
- BRAND NAME: Olodon® /Nolodon®/ Starelltec®
Quetiapine »
Nervous System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 25 mg, 100 mg, 150 mg, 200 mg, 300 mg
- REFERENCE PRODUCT: Seroquel® (AstraZeneca)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available IVb: available
- Shelf life: 36 months
- STORAGE CONDITIONS: Once opened - store for 28 days at a temperature below 30oC
- BATCH SIZE: 40 000
- POLPHARMA'S BRAND: Floxamic Neo®
- BRAND NAME: Floxamic® / Ekara®/ Genaxil®
Glycopyrronium »
Respiratory System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 44 mcg
- REFERENCE PRODUCT: Seebri Breezhaler® (Novartis)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available
- Shelf life: 24 months
- STORAGE CONDITIONS: Once opened, do not store above 25oC
- BATCH SIZE: 70 423 25 510
- POLPHARMA'S BRAND: Bimifree®
- BRAND NAME: Bimi® / Iricryn®
Glycopyrronium / Indacaterol »
Respiratory System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 43 mcg / 85 mcg
- REFERENCE PRODUCT: Ultibro Breezhaler® (Novartis)
- DOSSIER AVAILABILITY: EU
- Lactose Free: No
- Stability: II: available IVb: available
- Shelf life: 24 months
- STORAGE CONDITIONS: Once opened, do not store above 25oC
- BATCH SIZE: 70 423 25 510
- POLPHARMA'S BRAND: Bimifree® Combi
- BRAND NAME: Bimiduo® / Bapiri® / Bitifrin®
Cholecalciferol (Vitamin D3) »
Vitamins & Minerals
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Soft capsule
- STRENGTH: 20.000 IU
- REFERENCE PRODUCT: N/A
- DOSSIER AVAILABILITY: EU
- Lactose Free: Yes
- Stability: II: available IVa: not available
- Shelf life: 36 months
- STORAGE CONDITIONS: Store below 30oC. After first opening use in 90 days.
- BATCH SIZE: 43 103 43 103
- POLPHARMA'S BRAND: Briglau® PPH Free
- BRAND NAME: Briglau®/Briglafre® /Rivotra®
Olopatadine »
Anti-allergy
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 1 mg/ml
- Stability: II: Available IVb: Available
- Shelf life: 36 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia (Eye drop solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 5 ml 3x5 ml
- STORAGE CONDITIONS: Store below 30°C. Use within 90 days after opening.
- BATCH SIZE: 43860
- POLPHARMA'S BRAND: Olodon® free
- BRAND NAME: Olodon®/ Nolodon®/ Starelltec®
Moxifloxacin »
Anti- infectives Eye
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 5 mg/ml
- Stability: II: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: No
- PRESENTATION: Regular bottle (Eye drop soution)
- THERAPY DAYS: 30
- PRODUCT ML: 5 ml
- STORAGE CONDITIONS: Store below 30°C. Use within 28 days after opening.
- BATCH SIZE: 40000
- POLPHARMA'S BRAND: Floxamic Neo®
- BRAND NAME: Floxamic®/ Ekara®/ Genaxil®
Bimatoprost »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.3 mg/ml
- Stability: II: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia (Eye drops solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 3 ml 9 ml
- STORAGE CONDITIONS: Do not store above 25°C after opening.
- BATCH SIZE: 70,423 / 25,510
- POLPHARMA'S BRAND: Bimifree®
- BRAND NAME: Bimi®/ Iricryn®
Bimatoprost/ Timolol »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.3 mg/ml + 5 mg/ml
- Stability: II: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia (Eye drop solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 3 ml 9 ml
- STORAGE CONDITIONS: Do not store above 25°C after opening.
- BATCH SIZE: 70,423 / 25,510
- POLPHARMA'S BRAND: Bimifree® Combi
- BRAND NAME: Bimiduo®/ Bapiri®/ Bitifrin®
Brimonidine »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 2 mg/ml
- Stability: II: Available IVb: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia (Eye drop solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 5 ml 3x5 ml
- STORAGE CONDITIONS: Store below 30°C. Use within 90 days after opening.
- BATCH SIZE: 43103
- POLPHARMA'S BRAND: Briglau® PPH Free
- BRAND NAME: Briglau®/ Briglafre®/ Rivotra®
Dorzolamide »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 20 mg/ml
- Stability: II: Available IVb: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia (Eye drop solution)
- THERAPY DAYS: 30 60
- PRODUCT ML: 5 ml 10 ml
- STORAGE CONDITIONS: Do not store above 25°C after opening.
- BATCH SIZE: 45,455 / 22,727
- POLPHARMA'S BRAND: Nodofree®
- BRAND NAME: Dimaz®/Itoco®/ Optipres®
Dorzolamide/Timolol »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 20 mg/ml + 5 mg/ml
- Stability: II: Available IVb: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia (Eye drop solution)
- THERAPY DAYS: 30 60
- PRODUCT ML: 5 ml 10 ml
- STORAGE CONDITIONS: Do not store above 25°C after opening.
- BATCH SIZE: 45,455 / 22,727
- POLPHARMA'S BRAND: Nodofree® Combi
- BRAND NAME: Tidimaz®/ Codimaz®/ Olatalin®/ Olahyd®/ Amiptic®
Latanoprost »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.05 mg/ml
- Stability: II: Available IVb: On-going
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K (Eye drop solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 2.5 ml 7.5 ml
- STORAGE CONDITIONS: Do not freeze. Do not store above 25°C. Zone IV - 90 days in use study available.
- BATCH SIZE: 54,000 / 18,000
- POLPHARMA'S BRAND: Xalofree®
- BRAND NAME: Lifog®/Lotacryn®/Loravis®/Lagakomi®
Latanoprost/Timolol »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.05 mg/ml + 5 mg/ml
- Stability: II: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K (Eye drop solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 2.5 ml 7.5 ml
- STORAGE CONDITIONS: Do not freeze. Do not store above 25ºC
- BATCH SIZE: 54,000 / 18,000
- POLPHARMA'S BRAND: Xaloptic® Combi
- BRAND NAME: Lifoduo®/Lotaduo®/Loraduo®
Travoprost »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.04 mg/ml
- Stability: II: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K (Eye drop solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 2.5 ml 7.5 ml
- STORAGE CONDITIONS: Do not freeze. Protect from light.
- BATCH SIZE: 55,000 / 22,000
- POLPHARMA'S BRAND: Tipifree®
- BRAND NAME: Tipifree®/Traslor®
Travoprost/Timolol »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.04 mg/ml + 5 mg/ml
- Stability: II: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K (Eye drop solution)
- THERAPY DAYS: 30 90
- PRODUCT ML: 2.5 ml 7.5 ml
- STORAGE CONDITIONS: Do not freeze. After first opening keep the bottle in the outer carton to protect from light.
- BATCH SIZE: 55,000 / 22,000
- POLPHARMA'S BRAND: Tipifree® Combi
Acetazolamide »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 250 mg
- Shelf life: 60 months
- PRESERVATIVE FREE: No
- PRESENTATION: Tablets
- THERAPY DAYS: 30
- PRODUCT ML: -
- STORAGE CONDITIONS: -
- BATCH SIZE: 300000
- POLPHARMA'S BRAND: Diuramid®
- BRAND NAME: Diuramid®/ Diacarb®
Tropicamide »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 5 mg/ml 10 mg/ml
- Stability: II: Available
- Shelf life: 36 months
- PRESERVATIVE FREE: No
- PRESENTATION: Regular bottle (Eye drop solution)
- THERAPY DAYS: 30
- PRODUCT ML: 2 x 5 ml
- STORAGE CONDITIONS: Store below 25°C. Use within 4 weeks after opening.
- BATCH SIZE: 594,000 / 192,000
- POLPHARMA'S BRAND: Topicamidum WZF®
- BRAND NAME: -
Tobramycin / Dexamethasone »
Glaucoma
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 3 mg/ml + 1 mg/ml
- Stability: II: Available
- Shelf life: 24 months
- PRESERVATIVE FREE: No
- PRESENTATION: Regular bottle (Eye drop solution)
- THERAPY DAYS: 30
- PRODUCT ML: 5 ml
- STORAGE CONDITIONS: Store below 25°C. Use within 4 weeks.
- BATCH SIZE: 40000
- POLPHARMA'S BRAND: Trobosopt-Dex®
- BRAND NAME: -
OR11 »
- TYPE OF DOSSIER: Ophtalmics under development
- DOSSIER AVAILABILITY: Upon request
- DEVELOPMENT PHASE: Lab development
OD41 »
- TYPE OF DOSSIER: Ophtalmics under development
- DOSSIER AVAILABILITY: Upon request
- DEVELOPMENT PHASE: Lab development
OD31 »
- TYPE OF DOSSIER: Ophtalmics under development
- DOSSIER AVAILABILITY: Upon request
- DEVELOPMENT PHASE: Lab development
OI11 »
- TYPE OF DOSSIER: Ophtalmics under development
- DOSSIER AVAILABILITY: Upon request
- DEVELOPMENT PHASE: Lab development
*Polpharma Group API
CA: Dossier suitable for Canadian market
Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subjected to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the poduct in the import market(s). Based on exemption under art.5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Ticagrelor, Dapagliflozin and Linagliptin, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulation are met.