Api Product Portfolio

API PRODUCT PORTFOLIO

Farmabios is the global leader in manufacturing Steroids ...... 1-3 nonsterile and sterile steroids, with a focused Sterile Steroids ...... 3-4 portfolio of High Potent Substances (HPS) and High Potent Substances ...... 4 anticancer drugs. Cannabinoids ...... 4

Antineoplastics ...... 4

Developments ...... 4

PharmaZell offers a focused portfolio of small molecule APIs for the generic and originator Small Molecules ...... 5-6

pharmaceutical industry. Developments ...... 6

Active Ingredient Therapeutic Monograph Available Regulatory CAS Number Areas Grades Documentation

Steroids Amcinonide Dermatologic USP Micronized EU DMF 51022-69-6 Beclomethasone EU DMF PH.EUR. Standard Dipropionate Respiratory US DMF USP Micronized 5534-09-8 CEP Beclomethasone Dipropionate PH.EUR. EU DMF Respiratory Micronized Monohydrate USP US DMF 77011-63-3 Betamethasone EU DMF PH.EUR. Dipropionate Dermatologic Micronized US DMF USP 5593-20-4 CEP EU DMF Betamethasone PH.EUR. US DMF Valerate Dermatologic Micronized USP JP DMF 2152-44-5 CEP EU DMF PH.EUR. US DMF Budesonide Respiratory USP Micronized CEP 51333-22-3 Gastro-Intestinal JP JP DMF CN DMF Chlormadinone EU DMF PH.EUR. Acetate Contraceptive Micronized JP DMF JP 302-22-7 CEP* EU DMF Clobetasol PH.EUR. US DMF Propionate Dermatologic Micronized USP JP DMF 25122-46-7 CEP Clobetasone Butyrate Dermatologic PH.EUR. Micronized EU DMF 25122-57-0 Clocortolone EU DMF Pivalate Dermatologic USP Micronized US DMF 34097-16-0 Cyproterone EU DMF Acetate Anti-Androgen PH.EUR. Micronized US DMF 427-51-0 CEP Delmadinone Anti-Androgen INTERNAL Acetate Micronized EU DMF (Veterinary) SPEC. 13698-49-2 EU DMF Desonide Dermatologic USP Micronized US DMF 638-94-8 CN DMF Desonide Sodium INTERNAL Ophthalmic Standard EU DMF Phosphate SPEC. 94087-98-6

* Under submission / ** Product under patent, not for commercial use / # Sterile by Gamma Rays

Active Ingredient Therapeutic Monograph Available Regulatory CAS Number Areas Grades Documentation

Steroids Desoximetasone Dermatologic EU DMF USP Micronized 382-67-2 Ophthalmic US DMF Diflorasone Dermatologic EU DMF Diacetate JP Standard JP DMF 2557-49-5 Diflucortolone BP EU DMF Valerate Dermatologic Micronized JP JP DMF 59198-70-8 EU DMF Difluprednate INTERNAL Ophthalmic Micronized US DMF 23674-86-4 SPEC. JP DMF EU DMF Exemestane PH.EUR. Anti-Cancer Micronized US DMF 107868-30-4 USP CEP* Fludrocortisone EU DMF Adrenocortical PH.EUR. Acetate Micronized US DMF Insufficiency USP 514-36-3 CEP* Fludrocortisone INTERNAL Base Anti-Inflammatory Micronized EU DMF SPEC. 127-31-1 Flumethasone Advanced INTERNAL Standard EU DMF 2135-17-3 Intermediate SPEC. Flumethasone PH.EUR. Pivalate Dermatologic Micronized EU DMF USP 2002-29-1 Flunisolide EU DMF Anhydrous Anti-Asthmatic USP Standard US DMF 3385-03-3 Flunisolide EU DMF Hemihydrate Respiratory USP Micronized US DMF 77326-96-6 Fluocinonide USP US DMF Dermatologic Micronized 356-12-7 BP CN DMF EU DMF Fluocinolone US DMF PH.EUR. Acetonide Dermatologic Micronized JP DMF USP 67-73-2 CEP CN DMF Fluorometholone USP EU DMF Base Ophthalmic Micronized JP JP DMF 426-13-1 EU DMF Flurandrenolide Dermatologic USP Micronized US DMF 1524-88-5 JP DMF Fluticasone INTERNAL Furoate** Respiratory Micronized EU DMF SPEC. 80474-14-2 Fluticasone EU DMF PH.EUR. Propionate Respiratory Micronized US DMF USP 80474-14-2 CEP EU DMF Fulvestrant PH.EUR. Anti-Cancer Micronized US DMF 129453-61-8 USP CEP EU DMF Halcinonide Dermatologic USP Micronized US DMF 3093-35-4 CN DMF Halometasone INTERNAL Monohydrate Dermatologic Micronized EU DMF SPEC. 50629-82-8

* Under submission / ** Product under patent, not for commercial use / # Sterile by Gamma Rays

Active Ingredient Therapeutic Monograph Available Regulatory CAS Number Areas Grades Documentation

Steroids Hydrocortisone Dermatologic PH.EUR. EU DMF Acetate Micronized Ophthalmic USP CEP 50-03-3 Hydrocortisone PH.EUR. Hemisuccinate Anti-Inflammatory Standard EU DMF USP 2203-97-6 Loteprednol EU DMF INTERNAL Standard Etabonate Ophthalmic US DMF SPEC. Micronized 82034-46-6 Medroxyprogesterone EU DMF PH.EUR. Acetate Contraceptive Micronized US DMF USP 71-58-9 JP DMF Megestrol EU DMF PH.EUR. Acetate Anti-Cancer Micronized US DMF USP 595-33-5 CEP Methyltestosterone Anabolic- PH.EUR. EU DMF Micronized 58-18-4 Androgenic USP US DMF Mometasone EU DMF Respiratory- PH.EUR. Furoate Micronized US DMF Dermatologic USP 83919-23-7 CEP Osaterone Anti-Androgen INTERNAL Acetate Micronized EU DMF (Veterinary) SPEC. 105149-04-0 Paramethasone INTERNAL Acetate Dermatologic Micronized SPEC. EU DMF 1597-82-6 Prednisolone PH.EUR. Standard EU DMF Acetate Dermatologic USP Micronized CEP* 52-21-1 Prednisolone Valerate INTERNAL EU DMF Dermatologic Micronized Acetate SPEC. JP DMF 72064-79-0 Prednisolone INTERNAL Sodium Metasulfobenzoate Anti-Inflammatory Standard EU DMF SPEC. 3694-41-5 Triamcinolone Dermatologic PH.EUR. Standard EU DMF 124-94-7 Ophthalmic USP Micronized Triamcinolone EU DMF Dermatologic PH.EUR. Acetonide Micronized US DMF Ophthalmic USP 76-25-5 CEP Triamcinolone Dermatologic EU DMF Diacetate USP Micronized Ophthalmic US DMF 67-78-7 Triamcinolone EU DMF PH.EUR. Standard Hexacetonide Anti-Inflammatory US DMF USP Micronized 5611-51-8 CEP Sterile Steroids Beclomethasone PH.EUR. Dipropionate Respiratory Micronized EU DMF USP 5534-09-8 Budesonide PH.EUR. EU DMF Respiratory Micronized 51333-22-3 USP US DMF Hydrocortisone PH.EUR. EU DMF Acetate Ophthalmic Micronized USP CEP* 50-03-3 Loteprednol INTERNAL EU DMF Etabonate Ophthalmic Micronized SPEC. US DMF 82034-46-6

* Under submission / ** Product under patent, not for commercial use / # Sterile by Gamma Rays

Active Ingredient Therapeutic Monograph Available Regulatory CAS Number Areas Grades Documentation

Sterile Steroids EU DMF# Medroxyprogesterone PH.EUR. US DMF# Acetate (WHO Pre-Qualified) Contraceptive Micronized USP WHO DMF 71-58-9 CEP Methylprednisolone Injectable PH.EUR. EU DMF Acetate Micronized Anti-Inflammatory USP US DMF 53-36-1 Prednisolone Ophthalmic EU DMF PH.EUR. Acetate Injectable Micronized US DMF USP 52-21-1 Anti-Inflammatory CEP Prednisolone Anti-Inflammatory PH.EUR. Base Micronized EU DMF (Veterinary) USP 50-24-8 EU DMF# Triamcinolone Injectable PH.EUR. US DMF Acetonide Micronized Anti-Inflammatory USP JP DMF 76-25-5 CEP* High Potent Substances Formoterol EU DMF Fumarate PH.EUR. Respiratory Micronized US DMF Dihydrate USP CEP 183814-30-4 Isoproterenol Cardiovascular N.A. Standard N.A. 7683-59-2 Mivacurium INTERNAL EU DMF Chloride Anesthetic Standard SPEC. US DMF 106861-44-3 Tirofiban Hydrochloride INTERNAL EU DMF Cardiovascular Standard Monohydrate SPEC. US DMF 150915-40-5 Salmeterol EU DMF INTERNAL Xinafoate Respiratory Micronized US DMF SPEC. 94749-08-3 CEP Cannabinoids Cannabidiol DAC (German EU DMF (CBD, Synthetic) Various Standard Drug Codex) US DMF 13956-29-1 Antineoplastics PH.EUR. EU DMF Busulfan Anti-Cancer USP Standard US DMF 55-98-1 JP CEP* Melphalan HCl PH.EUR. EU DMF Anti-Cancer Standard 3223-07-2 USP US DMF Developments Prednisolone Caproate Anti-Inflammatory In-house Standard EU DMF 69164-69-8 Methylprednisolone Aceponate Standard Topical/Dermatology In-house EU DMF 86401-95-8 Micronized Dexamethasone Sodium Phosphate Ph.Eur EU DMF Anti-Inflammatory Standard 312-93-6 USP US DMF Brexanolone CNS In-house Standard Tech-pack 516-54-1

* Under submission / ** Product under patent, not for commercial use / # Sterile by Gamma Rays

Active Ingredient Therapeutic Monograph Available Regulatory Produced CAS Number Areas Grades Documentation In

Small Molecules Balsalazide Disodium Anti-Inflammatory US DMF USP Standard RAU 150399-21-6 Gastrointestinal EU DMF CEP EU DMF Celecoxib (Form III) PH.EUR. Fine NSAID US DMF VIZ 169590-42-5 USP Micronized RU DMF* CA DMF Etoricoxib (Form I) Standard Arthritis API QUALITY EU DMF VIZ 202409-33-4 Micronized CEP Indapamide Anti-Hypertensive Standard PH.EUR. EU DMF VIZ 26807-65-8 Diuretic Micronized RU DMF* L-Cysteine HCL Monohydrate PH.EUR. Standard CEP Various CHE 7048-04-6 USP Fine EU DMF L-Cysteine HCl Standard Anhydrous Various API QUALITY EU DMF CHE Fine 52-89-1 CEP L-Cystine Standard Various PH.EUR. EU DMF CHE 56-89-3 Fine US DMF Magnesium Orotate Standard Dietary Supplement API QUALITY EU DMF CHE 34717-03-8 Fine CEP Mesalamine EU DMF Dense Mesalazine US DMF Anti-Inflammatory PH.EUR. Fine RAU 5-Aminosalicylic Acid JP DMF Gastrointestinal USP Coarse VIZ ASA CA DMF Micronized 89-57-6 KR DMF TW DMF 6-Methyluracil Skin Burn Treatment Standard EU DMF* API QUALITY CHE 626-48-2 Dietary Supplement Micronized RU DMF* CEP N-Acetylcysteine Mucolytic Fine PH.EUR. EU DMF NAC Anti-Oxidant N.A.N.H. # RAU USP US DMF 616-91-1 Parenteral Nutrition Pyrogenfree CA DMF CEP EU DMF Propafenone Fine US DMF PH.EUR. RAU Hydrochloride Anti-Arrhythmic Coarse CA DMF USP CHE 34183-22-7 Micronized KR / CN DMF * BR DMF* TH / ID DM S-Carboxymethylcysteine Standard CEP Carbocysteine PH.EUR. CHE Mucolytic Micronized EU DMF SCC JP RAU N.A.N.H. # JP DMF 638-23-3 S-Carboxymethylcysteine- Standard L-Lysinate Mucolytic API QUALITY Dense EU DMF CHE 49673-81-6 N.A.N.H. # Teriflunomide Relapsing Forms Of API QUALITY Standard US DMF VIZ 163451-81-8 Multiple Sclerosis Ursodeoxycholic Acid Standard CEP PH.EUR. Ursodiol Milled EU DMF Cholelitholytic Agent USP GRO UDCA Milled HF US DMF* IP 128-13-2 Micronized CA DMF

# non-animal and non-human origin / *in preparation RAU = Raubling, Germany / CHE = Chennai, India / VIZ = Vizag, India / GRO = Gropello, Italy

Active Ingredient Therapeutic Monograph Available Regulatory Produced CAS Number Areas Grades Documentation In

Small Molecules Zinc Orotate Dihydrate Standard Dietary Supplement API QUALITY EU DMF CHE 60388-02-5 Micronized Developments Chenodeoxycholic Acid Under Cholelithocholic Agent API QUALITY DMF VIZ 474-25-9 Development Cholic Acid Building Bloc For Bile INTERMEDATE N.A. N.A. VIZ 81-25-4 Acid Derivates Ozanimod Relapsing Forms Of Under Under API QUALITY VIZ 1306760-87-1 Multiple Sclerosis Development Development

Roxadustat Dialysis-Dependent Under Under API QUALITY VIZ 808118-40-3 Chronic Kidney Disease Development Development

Bile Acid Derivates Please contact us if you are looking for such a derivative.

# non-animal and non-human origin / *in preparation RAU = Raubling, Germany / CHE = Chennai, India / VIZ = Vizag, India / GRO = Gropello, Italy

Our products are offered for sale only in countries where their importation does not represent an infringement of third parties’ rights according to local patent laws .

www .pharmazell-group .com

Pharmazell GmbH Rosenheimer Str . 43 83064 Raubling, Germany Phone: +49 (0)80 35-88-0 www .pharmazell .com Farmabios SPA Via Pavia, 1 27027 Gropello Cairoli (PV), Italy Phone: +39 (0)382 8191 www .farmabios .com © January 2021 6