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: 5mg / 850mg 5mg / 1000mg 12.5mg / 500mg 12.5mg / 850mg 12.5mg / 1000mg
- REFERENCE PRODUCT: Synjardy ® / Boehringer Ingelheim
- DOSSIER AVAILABILITY: EU: Q2 2025
Linagliptin* / Metformin »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2.5mg / 500mg 2.5mg / 850mg 2.5mg / 1000mgº
- REFERENCE PRODUCT: Jentadueto ® / Boehringer Ingelheim
- DOSSIER AVAILABILITY: EU: Q4 2024
Baricitinb »
Allergy/Immuno
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2mg / 4mg
- REFERENCE PRODUCT: Olumiaant® / Lilly
- DOSSIER AVAILABILITY: EU: Q4 2026
Upadacitinib »
Allergy/Immuno
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Prolonged - release tablets
- STRENGTH: 15mg /30mg / 45mg
- REFERENCE PRODUCT: Rinvoq® / Abbvie
- DOSSIER AVAILABILITY: EU: Q4 2027
Ozanimod »
Nervous System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Hard capsules
- STRENGTH: 0,23mg / 0,46mg / 0,92mg
- REFERENCE PRODUCT: Zeposia® / BMS
- DOSSIER AVAILABILITY: EU: Q1 2028
Fluticasone / Vilanterol »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 92mcg / 22mcg / 184mcg / 22mcg
- REFERENCE PRODUCT: Bro Ellipta® / GSK
- DOSSIER AVAILABILITY: EU: Q4 2026
Umeclidinium / Vilanterol »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 55mcg / 22 mcg
- REFERENCE PRODUCT: Anoro Ellipta® /GSK
- DOSSIER AVAILABILITY: EU: Q2 2027
Fluticasone /Umeclidinium / Vilanterol »
Respiratory System
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 100mcg / 74,2mcg / 62,5mcg 200mcg / 74,2mcg / 62,5mcg
- REFERENCE PRODUCT: Trelegy Ellipta® /GSK
- DOSSIER AVAILABILITY: EU: Q3 2030
Finerenone »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film-Coated Tablets
- STRENGTH: 10mg / 20mg
- REFERENCE PRODUCT: Kerendia® / Bayer
- DOSSIER AVAILABILITY: EU: Q3 2026
Bempedoic Acid »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film-Coated Tablets
- STRENGTH: 180mg
- REFERENCE PRODUCT: Nilemdo® / Daiichi Sankyo (Esperion)
- DOSSIER AVAILABILITY: EU: Q3 2025
Bempedoic Acid / Ezitimibe »
Cardiology
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Film-Coated Tablets
- STRENGTH: 180mg / 10 mg
- REFERENCE PRODUCT: Nustendi® / Daiichi Sankyo (Esperion)
- DOSSIER AVAILABILITY: EU: Q4 2026
Avibactam / Ceftazidime »
Anti-infectives for systemic use
- TYPE OF DOSSIER: Under development generics
- PHARMACEUTICAL FORM: Powder for Injection
- STRENGTH: 500mg / 2g
- REFERENCE PRODUCT: Zavicefta® / Pfizer (Abbvie / Allergan)
- DOSSIER AVAILABILITY: EU: Q2 2026
CV31 »
Cardiovascular System
- TYPE OF DOSSIER: Under development value added
- INDICATION: Hypertension
- DEVELOPMENT PHASE: Clinical development
CV22 »
Cardiovascular System
- TYPE OF DOSSIER: Under development value added
- INDICATION: Hypertension / Heart Failure
- DEVELOPMENT PHASE: Lab development
Dapagliflozin* / MetforminCA »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5mg / 850mg 5mg / 1000mg
- REFERENCE PRODUCT: Xigduo® / AstraZeneca
- Lactose Free: Yes
- Stability: II: on-going IVa: ext. from b IVb: on-going
- Shelf life: 24 months (36 months in Q3 2024) 24 months (36 months in Q3 2024)
Dapagliflozin*CA »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5mg 10mg
- REFERENCE PRODUCT: Forxiga® / AstraZeneca
- Lactose Free: Yes
- Stability: II: on-going IVa: ext. from b IVb: on-going
- Shelf life: 36 months 36 months
Empagliflozin*CA »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 10mg 25mg
- REFERENCE PRODUCT: Jardiance® / Boehringer Ingelheim
- Lactose Free: Yes
- Stability: II: on-going IVa: ext. from b IVb: on-going
- Shelf life: 36 months 36 months - Not store above 30 oC
Linagliptin*CA »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5mg
- REFERENCE PRODUCT: Trajenta® / Boehringer Ingelheim
- Lactose Free: Yes
- Stability: II: on-going IVa: ext. from b IVb: on-going
- Shelf life: 36 months 36 months
Orlistat »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Hard capsules
- STRENGTH: 120mg
- REFERENCE PRODUCT: Xenical® / Roche
- 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: 60mg
- REFERENCE PRODUCT: Alli® / GSK
- Lactose Free: Yes
- Stability: II: available IVa: not available IVb: not available
- Shelf life: 24 months
Sitagliptin* »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 25mg 50mg 100mg
- REFERENCE PRODUCT: Januvia® / Merck
- Lactose Free: Yes
- Stability: II: available IVa: not available IVb: available
- Shelf life: 36 months
Sitagliptin*/ Metformin »
Alimentary tract & metabolism
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 50mg / 850mg 50mg / 1000mg
- REFERENCE PRODUCT: Janumet® / Merck
- Lactose Free: Yes
- Stability: II: available IVa: not available IVb: available
- Shelf life: 24 months
Aciclovir »
Anti-infectives for systemic use
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Tablets
- STRENGTH: 200mg 400mg 800mg
- REFERENCE PRODUCT: Zovirax® / GSK
- Lactose Free: Yes
- Stability: II: available IVa: not available IVb: not available
- Shelf life: 36 months
Apremilast*CA »
Antineoplastic & Immunomodulating Agents
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 10mg 20mg 30mg
- REFERENCE PRODUCT: Otezla® / Celgene
- Lactose Free: Yes
- Stability: II: available IVa: not available IVb: not available
- Shelf life: 12 months (target 36)
Apixaban* »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2.5mg 5mg
- REFERENCE PRODUCT: Eliquis® / Bristol-Myers Squibb
- Lactose Free: No
- Stability: II: available IVa: ext. from b IVb: available
- Shelf life: 36 months
Rivaroxaban*CA »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2.5mg 10mg 15mg 20mg
- REFERENCE PRODUCT: Xarelto® / Bayer
- Lactose Free: No
- Stability: II: on-going IVa: ext. from b IVb: on-going
- Shelf life: 24 months
Rivaroxaban* »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Capsules
- STRENGTH: 10mg 15mg 20mg
- REFERENCE PRODUCT: Xarelto® / Bayer
- Lactose Free: No
- Stability: II: on-going
- Shelf life: 24 months
Ticagrelor* »
Blood & Blood forming organs
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 60mg 90mg
- REFERENCE PRODUCT: Brilique® / AstraZeneca
- Lactose Free: Yes
- Stability: II: available IVa: ext. from b IVb: available
- Shelf life: 36 months
Ramipril / Indapamide »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Hard capsules (IR dosage form)
- STRENGTH: 5mg / 2.5mg 10mg / 2.5mg 5mg / 1.25mg 10mg / 1.25mg
- REFERENCE PRODUCT: New combination
- Lactose Free: No
- Stability: II: on-going
- Shelf life: 36 months
Sacubitril / Valsartan »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 49mg / 51mg 24mg/ 26mg 97mg / 103mg
- REFERENCE PRODUCT: Entresto® / Novartis
- Lactose Free: Yes
- Stability: II: available IV: not available
- Shelf life: 48 months
Hydrochlorothiazide* »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Tablets
- STRENGTH: 12.5mg 25mg 50mg
- REFERENCE PRODUCT: Esidrex® / Novartis
- Lactose Free: No
- Stability: II: available IVa: not available IVb: not available
- Shelf life: 60 months
Ramipril / Amlodipine »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Hard capsules
- STRENGTH: 5mg / 5mg 5mg / 10mg 10mg / 5mg 10mg / 10mg
- REFERENCE PRODUCT: Tritace® (Ramipil) / Sanofi & Norvasc® (Amlodipine) / Pfizer
- Lactose Free: Yes
- Stability: II: available IVa: not available IVb: not available
- Shelf life: 36 months
Rosuvastatin »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 5mg 10mg 20mg
- REFERENCE PRODUCT: Crestor(TM) / AstraZeneca
- Lactose Free: No
- Stability: II: available IVa: (12 months) IVb: not available
- Shelf life: 36 months
Telmisartan / Amlodipine »
Cardiovascular System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Bilayered Tablets
- STRENGTH: 40mg / 5mg 40mg / 10mg 80mg / 5mg 80mg / 10mg
- REFERENCE PRODUCT: Twynsta® / Boehringer Ingelheim
- Lactose Free: Yes
- Stability: II: available IVa: ext. from b IVb: available
- Shelf life: 36 months
Dimetindene »
Dermatologicals
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Gel
- STRENGTH: 1mg /g (20g) 1mg /g (30g) 1mg /g (50g)
- REFERENCE PRODUCT: Fenistil(TM) / Novartis
- Lactose Free: Yes
- Stability: II: available IVa: ext. from b IVb: available
- Shelf life: 36 months
Tadalafil* »
Genito-Urinary System & Sex Hormones
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 2.5mg 5mg 10mg 20mg
- REFERENCE PRODUCT: Cialis® / Eli Lilly
- Lactose Free: No
- Stability: II: available IVa: ext. from b 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
- Stability: II: available IVa: on-going IVb: on-going
- Shelf life: 36 months
Dimethyl FumarateCA »
Nervous System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Gastro -resistant hard capsules
- STRENGTH: 120mg 240mg
- REFERENCE PRODUCT: Tecfidera® / Biogen Idec
- Lactose Free: Yes
- Stability: II: on-going IVa: ext.from b IVb: on-going
- Shelf life: 36 months / do not store above 30oC (zone II) 24 months / do not store above 30oC (zone IVb)
Memantine hydrochloride »
Nervous System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film - coated tablets
- STRENGTH: 10mg 20mg
- REFERENCE PRODUCT: Ebixa® / Lundbeck
- Lactose Free: No
- Stability: II: available IVa: available IVb: no ext. from a
- Shelf life: 36 months
Quetiapine »
Nervous System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Film- coated tablets
- STRENGTH: 25mg / 100mg 150mg / 200mg 300mg
- REFERENCE PRODUCT: Seroquel® / AstraZeneca
- Lactose Free: No
- Stability: II: available IVa: available IVb: available
- Shelf life: 36 months
Xylomethazoline/ Dexpanthenol OTC »
Respiratory System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Nasal spray solution
- STRENGTH: 1.0mg / 50mg / ml (10ml) 0.5mg / 50mg / ml (10 ml)
- REFERENCE PRODUCT: Nasic(TM) / Cassella-med
- Lactose Free: Yes
- Stability: II: available IVa: ext. from b IVb: available
- Shelf life: 24 months (0.5mg) 36 months (1.0mg)
Glycopyrronium »
Respiratory System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 44mcg
- REFERENCE PRODUCT: Seebri Breezhaler® / Novartis
- Lactose Free: No
- Stability: II: available
- Shelf life: 24 monts
Glycopyrronium / Indacaterol »
Respiratory System
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Inhalation powder
- STRENGTH: 43mcg / 85mcg
- REFERENCE PRODUCT: Ultibro Breezhaler® / Novartis
- Lactose Free: No
- Stability: II: available IVb: on-going
- Shelf life: 24 months
Cholecalciferol (Vitamin D3) »
Vitamins & Minerals
- TYPE OF DOSSIER: Available
- PHARMACEUTICAL FORM: Soft capsule
- STRENGTH: 20.000 IU
- REFERENCE PRODUCT: N/A
- Lactose Free: Yes
- Stability: II: available IVa: not available
- Shelf life: 36 months
OR11 »
- TYPE OF DOSSIER: Ophtalmics under development
- INDICATION: Red eye
- DEVELOPMENT PHASE: Lab development
OD41 »
- TYPE OF DOSSIER: Ophtalmics under development
- INDICATION: Dry eye
- DEVELOPMENT PHASE: Lab development
OD31 »
- TYPE OF DOSSIER: Ophtalmics under development
- INDICATION: Dry eye
- DEVELOPMENT PHASE: Lab development
OI11 »
- TYPE OF DOSSIER: Ophtalmics under development
- INDICATION: Infection
- DEVELOPMENT PHASE: Lab development
O21 »
- TYPE OF DOSSIER: Ophtalmics under development
- INDICATION: Glaucoma
- DEVELOPMENT PHASE: Lab development
Olopatadine »
Anti-allergy (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 1mg/ml
- Shelf life: 36 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia ®
- THERAPY DAYS: 30 90
- STABILITY ZONE II: Yes Yes
- STABILITY ZONE IV: No TBD
- PRODUCT ML: 5.0 3 x 5.0
- STORAGE CONDITIONS: Store below 30oC. After first opening use in 90 days.
- BATCH SIZE: 43 860
Moxifloxacin »
Anti- infectives Eye (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 5mg/ml
- Shelf life: 24 months
- PRESERVATIVE FREE: No
- PRESENTATION: Regular bottle
- THERAPY DAYS: 30
- STABILITY ZONE II: Yes
- STABILITY ZONE IV: No
- PRODUCT ML: 5.0
- STORAGE CONDITIONS: Once opened - store for 28 days at a temperature below 30oC
- BATCH SIZE: 40 000
Bimatoprost »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.3mg /ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia ®
- THERAPY DAYS: 30
- STABILITY ZONE II: Yes
- STABILITY ZONE IV: No
- PRODUCT ML: 3.0
- STORAGE CONDITIONS: Once opened, do not store above 25oC
- BATCH SIZE: 70 423 25 510
Bimatoprost/ Timolol »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: (0.3mg / 5mg) /ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia ®
- THERAPY DAYS: 30 90
- STABILITY ZONE II: Yes
- STABILITY ZONE IV: No
- PRODUCT ML: 3.0
- STORAGE CONDITIONS: Once opened, do not store above 25oC
- BATCH SIZE: 70 423 25 510
Brimonidine »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 2mg /ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia ®
- THERAPY DAYS: 30 90
- STABILITY ZONE II: Yes Yes
- STABILITY ZONE IV: No No
- PRODUCT ML: 5.0 3 x 5.0
- STORAGE CONDITIONS: Store below 30oC. After first opening use in 90 days.
- BATCH SIZE: 43 103 43 103
Dorzolamide »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 20mg/ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia ®
- THERAPY DAYS: 30 60
- STABILITY ZONE II: Yes Yes
- STABILITY ZONE IV: No No
- PRODUCT ML: 5.0 10.0
- STORAGE CONDITIONS: Once opened, do not store above 25oC
- BATCH SIZE: 45 455 22 727
Dorzolamide/Timolol »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: (20mg/5mg) /ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Nemera Novelia ®
- THERAPY DAYS: 30 60
- STABILITY ZONE II: Yes Yes
- STABILITY ZONE IV: No No
- PRODUCT ML: 5.0 10.0
- STORAGE CONDITIONS: Once opened, do not store above 25oC
- BATCH SIZE: 45 455 22 727
Latanoprost »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0,05mg /ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K ®
- THERAPY DAYS: 30 90
- STABILITY ZONE II: Yes Yes
- STABILITY ZONE IV: In progress In progress
- PRODUCT ML: 2.5 7.5
- STORAGE CONDITIONS: Do not freeze. Do not store above 25oC Zone IV- 90 days in use study in progress.
- BATCH SIZE: 54 000 18 000
Latanoprost/Timolol »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: (0.05mg / 5mg) / ml
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K ®
- THERAPY DAYS: 30 90
- STABILITY ZONE II: In progress In progress
- PRODUCT ML: 2.5 7.5
- BATCH SIZE: 54 000 18 000
Travoprost »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 0.04mg / ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K ®
- THERAPY DAYS: 30 90
- STABILITY ZONE II: Yes Yes
- STABILITY ZONE IV: In progress In progress
- PRODUCT ML: 2.5 7.5
- STORAGE CONDITIONS: Do not freeze. After first opening keep the bottle in the outer carton in order to protect from light.
- BATCH SIZE: 55 000 22 000
Travoprost/Timolol »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: (0.04mg / 5mg) / ml
- Shelf life: 24 months
- PRESERVATIVE FREE: Yes
- PRESENTATION: Aeropump 3K ®
- THERAPY DAYS: 30 90
- STABILITY ZONE II: In progress In progress
- STABILITY ZONE IV: In progress In progress
- PRODUCT ML: 2.5 7.5
- STORAGE CONDITIONS: Do not freeze. After first opening keep the bottle in the outer carton in order to protect from light.
- BATCH SIZE: 55 000 22 000
Acetazolamide »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 250mg
- Shelf life: 60 months
- PRESERVATIVE FREE: No
- PRESENTATION: Tablets
- THERAPY DAYS: 30
- STABILITY ZONE II: No
- STABILITY ZONE IV: No
- STORAGE CONDITIONS: -
- BATCH SIZE: 300 000
Tropicamide »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: 5mg/ml 10mg / ml
- Shelf life: 36 months
- PRESERVATIVE FREE: No No
- PRESENTATION: Regular bottle Regular bottle
- THERAPY DAYS: 30 30
- STABILITY ZONE II: Yes Yes
- STABILITY ZONE IV: No No
- PRODUCT ML: 2 x 5 2 x 5
- STORAGE CONDITIONS: Store below 25oC. After first opening use in 4 weeks.
- BATCH SIZE: 192 000 594 000
Tobramycin / Dexamethasone »
Glaucoma (Eye drops solution)
- TYPE OF DOSSIER: Ophtalmics available
- STRENGTH: (3mg +1mg) /ml
- Shelf life: 24 months
- PRESERVATIVE FREE: No
- PRESENTATION: Regular bottle
- THERAPY DAYS: 30
- STABILITY ZONE II: Yes
- STABILITY ZONE IV: No
- PRODUCT ML: 5
- STORAGE CONDITIONS: Store below 25oC. After first opening use in 4 weeks.
- BATCH SIZE: 40 000
*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.