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AMSA An. Mat. Sint. Affini S.p.A. Unipersonale
Registered Office: Viale del Ghisallo 20, 20151 Milano (MI) – Italy
R.E.A. Milano 601857
Cosma S.p.A. Unipersonale
Registered Office: Via Colleoni 15-17, 24040 Ciserano (BG) – Italy
R.E.A. Bergamo 167479
Clarochem Ireland Ltd.
Registered Office: Damastown, Mulhuddart, Dublin 15 – Republic of Ireland
VAT No. IE6517797I

Generic API

CFM GROUP

Generic API

Through our long experience in extremely diversified markets we gained an extensive familiarity in tackling complex business and regulatory challenges.
A high degree of flexibility, a light hierarchical organization and a quick reactivity of the decision makers also on the financial matters allows the group to quickly respond to clients, to market needs and to new projects.
This is specially important in the generic field, where knowledge and awareness of timing issues and filing/approval procedures is of paramount importance.
AMSA, COSMA and Clarochem Ireland are exclusively involved in API manufacturing, without any involvement in the finished dosage business.
This, together with complete financial independence of the group, puts the customer at ease for the lack of any potential conflict of interests.

Cosma S.p.A

Generic API

AMISULPRIDE

AMISULPRIDE

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CARPROFEN

CARPROFEN

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CETIRIZINE 2HCl

CETIRIZINE 2HCl

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D,L-CLOPERASTINE FENDIZOATE

D,L-CLOPERASTINE FENDIZOATE

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FIROCOXIB

FIROCOXIB

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GLICLAZIDE

GLICLAZIDE

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HYDROXYZINE HCl

HYDROXYZINE HCl

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HYDROXYZINE PAMOATE

HYDROXYZINE PAMOATE

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LABETALOL HCl

LABETALOL HCl

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LEVOMILNACIPRAN HCl

LEVOMILNACIPRAN HCl

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METOCLOPRAMIDE HCI

METOCLOPRAMIDE HCI

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MILNACIPRAN HCl

MILNACIPRAN HCl

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MIRABEGRON

MIRABEGRON

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PROPRANOLOL HCl

PROPRANOLOL HCl

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PYRANTEL PAMOATE

PYRANTEL PAMOATE

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RANOLAZINE

RANOLAZINE

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RIFAXIMIN

RIFAXIMIN

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SULFINPYRAZONE

SULFINPYRAZONE

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TORSEMIDE

TORSEMIDE

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AMSA S.p.A

Generic API

AMANTADINE HCl

AMANTADINE HCl

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BROMHEXINE HCl

BROMHEXINE HCl

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D,L-DROPROPIZINE

D,L-DROPROPIZINE

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ETODOLAC

ETODOLAC

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FLECAINIDE ACETATE

FLECAINIDE ACETATE

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GLIPIZIDE

GLIPIZIDE

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GLYCOPYRROLATE METHYLBROMIDE

GLYCOPYRROLATE METHYLBROMIDE

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LURASIDONE HCl

LURASIDONE HCl

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MEMANTINE HCl

MEMANTINE HCl

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MELOXICAM

MELOXICAM

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METOCLOPRAMIDE BASE/HCl/2HCl

METOCLOPRAMIDE BASE/HCl/2HCl

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OXANTEL PAMOATE

OXANTEL PAMOATE

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Clarochem Ireland Ltd

Generic API

DEXKETOPROFEN TROMETAMOL

DEXKETOPROFEN TROMETAMOL

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PHOSPHORYLCOLAMINE

PHOSPHORYLCOLAMINE

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RIFAXIMIN

RIFAXIMIN

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KETOPROFEN LYSINATE

KETOPROFEN LYSINATE

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DROXIDOPA

DROXIDOPA

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LEVODROPROPIZINE

LEVODROPROPIZINE

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Products

Custom manufacturing

Beside the generic API activities, we have a robust custom manufacturing capability and experience in both intermediates and APIs, demonstrated by a good track record of projects completed for our customers, including successful commercial launches of new chemical entities.


Deep knowledge of industrial and regulatory issues, expertise in process development and a wide range of complementary production scales, all in GMP, allow us to identify ideal and robust processes to carry the customer lead from medicinal chemistry through all the clinical phases, up to the final commercial production. A responsible approach on costs and efficiency, well developed during six decades of competition on the generic market, is applied also to the synthesis of new chemical entities since the beginning.

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AMISULPRIDE

anti-psychotic

One of the most prescribed anti-psychotic molecules in Europe; also recently approved in the US in injectable formulation for Post-Operative Nausea and Vomiting (PONV). API grades available for oral and parenteral applications.

CARPROFEN

anti-inflammatory

COX-1/COX-2 inhibitor widely used in veterinary care for management of pain and inflammation. Mainly used in dogs, but sees application also in other animals including horses, cattle and camelids. API grades available for oral and parenteral applications.

CETIRIZINE 2HCl

anti-histaminic

Oral 2nd generation antihistaminic, generally used in treatment of allergic rhynitis, dermatitis, urticaria. Recently approved also as ophtalmic solution, for ocular itching in allergic conjuctivitis

D,L-CLOPERASTINE FENDIZOATE

anti-tussive

Non-opioid cough suppressant introduced in Japan in the 70’s. Unlike several other antitussive agents, its employ in paediatric population has been widely assessed. Fully integrated production encompassess in-house, GMP manufacturing of fendizoic acid.

FIROCOXIB

anti-inflammatory

Next-generation, COX-2 selective anti inflammatory for dogs and horses. Sees use in management of osteoarthritis, as well as post-operative pain. Its COX-2 selectivity allows administration with or without food. Manufactured by COSMA through a patented, proprietary process.

GLICLAZIDE

anti-diabetic

Anti-diabetic sulfonylurea included in the WHO’s List of Essential Medicines, used for control of hyperglycemia in type 2 diabetes

HYDROXYZINE HCl

anti-histaminic

1st generation antihistaminic, on the market since 1956. Besides its predominant action as a histamine H1 receptor inverse agonist, hydroxyzine exhibits a weak antiserotoninergic effect. As such, it is used both in the treatment of allegic conditions (itchiness, urticaria, pruritus) and as a mild anxiolytic. Also sees use in treatment of nausea from motion sickness.

HYDROXYZINE PAMOATE

anti-histaminic

1st generation antihistaminic, on the market since 1956. Besides its predominant action as a histamine H1 receptor inverse agonist, hydroxyzine exhibits a weak antiserotoninergic effect. As such, it is used both in the treatment of allegic conditions (itchiness, urticaria, pruritus) and as a mild anxiolytic. Also sees use in treatment of nausea from motion sickness. Fully integrated production encompassess in-house, GMP manufacturing of fendizoic acid.

LABETALOL HCl

anti-hypertensive

Dual alpha- and beta-blocker used to treat several types of hypertension via oral and intravenous administration. API grades available for oral and parenteral applications.

LEVOMILNACIPRAN HCl

anti-depressive

Atypical Serotonine-Norepineprine reuptake inhibitor, approved in the US for Major Depressive Disorders. Generic launch expected not earlier than 2023.

METOCLOPRAMIDE HCl

anti-emetic

Prokinetic agent commonly used to treat and prevent nausea and vomiting, for gastroparesys, and to help with gastroesophageal reflux disease. It is also used to treat migraine headaches. It also sees use in perioperative setting. API grades available for oral and parenteral applications.

MILNACIPRAN HCl

anti-fbromyalgic

Atypical Serotonine-Norepineprine reuptake inhibitor, used in different countries as antidepressive and/or in the treatment of fibromyalgia.

MIRABEGRON

overactive bladder disease

First-in-class beta-3 adrenergic agonist, used to treat overactive bladder.

PROPRANOLOL HCl

anti-hypertensive

One of the oldest and most used molecules of the beta blocker class. It was the first beta-blocker effectively used in the treatment of coronary artery disease and hypertension. More recently, it saw use in hemangiomas and in prevention of migraine, for which it is included in the WHO’s Essential Medicines List. Scottish scientist Sir James Whyte Black was awarded the 1988 Nobel Prize in Medicine for its invention. API grades available for oral and parenteral applications.

PYRANTEL PAMOATE

anti-helminthic

Anti helmintic mainly used in the veterinary field, with limited use in humans. Part of the WHO’s Essential Medicines List. Of particular prospective interest for the treatment of human infections, in conjuction with the emerging resistances to antihelmintic drugs of the benzimidazole class. Fully integrated production encompasses in-house manufacturing of GMP pamoic acid.

RANOLAZINE

anti-anginal

Used to treat chronic angina. Generics were recently launched in the US, while in the EU the molecule is is still under data protection.

RIFAXIMIN

non-systemic antibiotic

Semi-synthetic antibiotic of the rifamycin family. Used for several gastrointestinal indications including Traveller’s Diarrhea, Hepatic Encephalopathy, and IBS. 

SULFINPYRAZONE

anti-gout

Uricosuric agent used to treat gout. Also used in cardiology for prophylaxis of post-myocardial infarction complications.

TORSEMIDE

diuretic

Sulfonamide and loop diuretic, used to treat fluid overload due to heart failure and high blood pressure. Available as polymorphic forms I and II

AMANTADINE HCl

Parkinson’s disease; anti-viral

Used in the treatment of Parkinson’s disease. In 2017, the extended release formulation was approved for use in the treatment of levodopa-induced dyskinesia. Also has a widespread, though controversial, use as an antiviral in humans and poultry.

BROMHEXINE HCl

mucolytic

One of the most commonly used mucolytic APIs, and a prodrug of ambroxol. AMSA is possibly the only European producer of Bromhexine HCl on the open market.

D,L-DROPROPIZINE

anti-tussive

Non-opioid cough suppressor with peripheral activity. Lacking any activity on the central nervous system, it does not cause side effects such as constipation or respiratory depression which can be produced by opioid antitussives such as codeine and its derivatives.

ETODOLAC

anti-inflammatory

Non-steroideal antiinflammatory widely used on the global market.

FLECAINIDE ACETATE

anti-arrhythmic

Used in the the management of cardiac arrhytmias. AMSA was granted a patent covering its production process.

GLIPIZIDE

anti-diabetic

2nd generation sulfonylurea, used alone or in combination to treat type 2 diabetes. Available in milled, micronized and ultramicronized grades.

GLYCOPYRROLATE METHYLBROMIDE

anti-cholinergic

Anticholinergic agent with a wide range of uses, encompassing peptic ulcer, hyperhydrosis, sialorrhea and COPD, as well as in pre-operatory setting. API grades available for oral, topical and parenteral applications.

LURASIDONE HCl

anti-psychotic

Atypical antipsychotic used for schizophrenia, with a favorable adverse effect profile. Though molecule patent coverage has expired, generic launch in regulated markets is expected from 2023 onwards.

MEMANTINE HCl

anti-Alzheimer

NDMA antagonist used in the treatment of Alzheimer’s disease, alone or in combination with Donepezil. AMSA manufacturing process is protected by a granted patent.

MELOXICAM

anti-inflammatory

Nonsteroidal anti-inflammatory compound used to treat pain and inflammation in rheumatic diseases and osteoarthritis, both in humans and animals. In recent years it was object of many reformulation approaches, generating several potential generic launch opportunities. API grades available for oral and parenteral applications.

METOCLOPRAMIDE BASE/HCl/2HCl

anti-emetic

Prokinetic agent commonly used to treat and prevent nausea and vomiting, for gastroparesys, and to help with gastroesophageal reflux disease. It is also used to treat migraine headaches. It also sees use in perioperative setting. API grades available for oral and parenteral applications.

OXANTEL PAMOATE

anti-helminthic

Anti helmintic used in the veterinary field, with proposed use in humans. Of particular prospective interest because of its activity against Trichuris trichiura, a soil-transmitted helmith resistant to more commonly used deworming agents. Fully integrated production encompasses in-house manufacturing of GMP pamoic acid.

DEXKETOPROFEN TROMETAMOL

anti-inflammatory

The stereisomer of Ketoprofen responsible for most of its pharmacological activity. Used alone or in combination with Tramadol, for oral or parenteral route. API grade available also for parenteral applications.

PHOSPHORYLCOLAMINE

dietary supplement

Used in veterinary care for prophylaxis and treatment of pathological syndromes linked to calcium and magnesium deficiences. Also used as a reconstituent for animals and humans. API grades available for oral and parenteral applications.

RIFAXIMIN

non-systemic antibiotic

Semi-synthetic antibiotic of the rifamycin family. Used for several gastrointestinal indications including Traveller’s Diarrhea, Hepatic Encephalopathy, and IBS. Clarochem offers an unique IP angle with its proprietary K polymorph, which allows immediate market entry in force of the current polymorph patent barriers.

KETOPROFEN LYSINATE

anti-inflammatory

Nonsteroidal anti-inflammatory compound; the lysine salt exhibits quicker absorption and reduced gastroitestinal toxicity compared to the free acid. A systematic meta-analysis of the efficacy of orally administered NSAIDs found ketoprofen to be significantly superior in relieving moderate-severe pain to both ibuprofen and diclofenac. Also formulated as mouthwash and suppositories.

DROXIDOPA

neurogenic orthostatic hypotension

 Prodrug to the neurotransmitter norepinephrine, capable of crossing the blood–brain barrier. Approved in Japan and the US to treat Neurogenic Orthostatic Hypotension

LEVODROPROPIZINE

anti-tussive

Non-opioid cough suppressor with peripheral activity. Lacking any activity on the central nervous system, it does not cause side effects such as constipation or respiratory depression which can be produced by opioid antitussives such as codeine and its derivatives.