02 — API Intermediates
Premium Intermediates
& Key Starting Materials
Bio Pharma Primo Impex is a cGMP-certified supplier of high-purity pharmaceutical intermediates with complete DMF dossiers, CEP filings, and multi-market regulatory compliance. Your trusted manufacturing partner for APIs and key starting materials globally.
29+
Intermediates
6+
DMF Filings
cGMP
Certified
⚗️ Quality at Every Step
Our intermediates and APIs are synthesised with the utmost precision and undergo rigorous quality checks — purity levels that exceed international benchmarks across IP, BP, USP, and EP pharmacopoeias.
📋 Regulatory Excellence
Manufacturing processes adhere to ICH Q7 GMP guidelines, certified by CDSCO, WHO-GMP, PMDA, and ISO. DMF dossiers available for USA (USFDA), Europe (CEP), Korea (KDMF), Japan (JDMF), and Brazil (ANVISA).
🌐 Reliable Global Supply
Consistent, uninterrupted supply to pharmaceutical manufacturers across 80+ countries. Custom synthesis and long-term contract manufacturing available as per client specifications and process requirements.
Cardiovascular
8 Intermediates
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Azilsartan Medoxomil Potassium Salt
ARB Anti-Hypertensive
2-ethoxy-1-{[2'-(5-oxo-4,5-dihydro-1,2,4-oxadiazol-3-yl)-1,1'-biphenyl-4-yl]methyl}-1H-benzimidazole-7-carboxylic acid [147403-03-0], Azilsartan Base
✓ DMF Available
KDMF Filing
Benazepril HCl
ACE Inhibitor
3-Bromo-2,3,4,5-tetrahydro-2-h-1-benzacepin–2one [86499-96-9], tert-Butyl (S)-2-(3-amino-2-oxo-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl)acetate [109010-60-8]
Not Filed
Irbesartan
ARB Anti-Hypertensive
2-Butyl-1,3-Diazaspiro-[4,4]Non-1-en-4-one hydrochloride (Spiro) [151257-01-1]
Not Filed
Nebivolol HCl
β₁-Selective Cardio-Selective β-Blocker
ISOMER A [793669-26-8], ISOMER B [876514-31-7]
✓ DMF Available
CEP Filing
Telmisartan
ARB Anti-Hypertensive
2-n-Propyl-4-methyl-6-(1-methylbenzimidaole-2-yl) benzimidazole [152628-02-9]
Not Filed
Ticagrelor
P2Y₁₂ ADP Receptor Antagonist / Antiplatelet
4,6-Dichloro-2-propylthiopyrimidine-5-amine [145783-15-9]
✓ DMF Available
Torsemide
Loop Diuretic / Antihypertensive
Sulfonylurea loop diuretic intermediate — available on request
Not Filed
Naftidrofuryl Oxalate
Vasodilator / Peripheral Vascular
1-(tetrahydro-2-furyl)-3-(1-naphthyl) propane-2-carboxylic acid (60% in toluene) [5379-26-4]
✓ DMF Available
CEP Filing
Neurological / CNS
3 Intermediates
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Biperiden Hydrochloride API
Muscarinic M1 Antagonist — Anti-Parkinson
Bicyclic piperidine derivative intermediate — available on request
Not Filed
Rasagiline Mesylate
Selective MAO-B Inhibitor — Anti-Parkinson
1-Aminoindane HCl [70146-15-5], (R)-(-)-1-Aminoindane HCl [10305-73-4]
✓ DMF Available
KDMF / JDMF Filing
Trazodone
SARI Antidepressant — Serotonin Antagonist & Reuptake Inhibitor
1-(3-chlorophenyl)-4-(3-chloropropyl)-Piperazine [52605-52-4], 1,2,4-Triazolo-[4,3-a]pyridine-3(2H)-one [6969-71-7]
✓ DMF Available
ANVISA Filing
Erectile Dysfunction
3 Intermediates
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Tadalafil
PDE5 Inhibitor — cGMP Phosphodiesterase Type 5 Inhibitor
(1R,3R)-Methyl 1-(benzo[d][1,3]dioxol-5-yl)-2,3,4,9-tetrahydro-1H-pyrido[3,4-b]indole-3-carboxylate hydrochloride [171752-68-4]
✓ DMF Available
Vardenafil
Selective PDE5 Inhibitor — Piperazinyl Ethyl Phenyl Scaffold
Imidazo[5,1-f][1,2,4]triazin-4(3H)-one derivative intermediate — available on request
Not Filed
Dapoxetine HCl
SSRI (Short-Acting) — Premature Ejaculation / IELT Prolonging Agent
3-(Napthalen-1-yloxy)-1-phenylpropan-1-ol [908291-72-5], Dapoxetine Base [119356-77-3]
✓ DMF Available
Anti-Inflammatory / Analgesic
2 Intermediates
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Etoricoxib API
Selective COX-2 Inhibitor NSAID — Pyridinyl Methylsulfonyl Scaffold
1-(6-Methylpyridin-3-Yl)-2-[4-(Methylsulfonyl)Phenyl] Ethanone [Ketosulfone] [221615-75-4], 2-Chloro-1,3-Bis(Dimethylamino) Trimethinium Hexafluoro Phosphate [249561-98-6]
Not Filed
Zaltoprofen API
Propionic Acid NSAID — COX-1/2 and Bradykinin B2 Receptor Inhibitor
5-(1-Carboxyethyl)-2-(phenylthio)phenylacetic acid [83237-49-4]
Not Filed
JDMF / KDMF Filing
Urology
2 Intermediates
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Solifenacin Succinate
Muscarinic M3 Antagonist — Overactive Bladder / OAB Agent
3-Quinuclidinone HCl [1193-65-3], R-(-)-3-Quinuclidinol [25333-42-0], S-1-Phenyl 1,2,3,4 tetrahydro isoquinoline [118864-75-8]
✓ DMF Available
Tamsulosin
Selective α₁A-Adrenoceptor Antagonist — Benign Prostatic Hyperplasia (BPH)
Tamsulosin Base [106133-20-4]
Not Filed
Antiepileptic / CNS
2 Intermediates
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Brivaracetam API
SV2A Ligand Antiepileptic — Levetiracetam Analogue
(R)-4-Propyldihydrofuran-2(3H)-one [63095-51-2]
Not Filed
Favipiravir
RNA-Dependent RNA Polymerase Inhibitor — Broad-Spectrum Antiviral
6-chloro-3-hydroxypyrazine-2-carbonitrile dicyclohexylamine salt [1137606-74-6]
✓ DMF Available
Hormonal / Other Intermediates
2 Intermediates
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Cabergoline Intermediates
Ergoline-Based Dopamine D₂ Agonist — Hyperprolactinaemia / Parkinson's
Cabergoline Acid — ergoline intermediate for cabergoline API synthesis
Not Filed
Pregabalin
α₂δ Subunit Voltage-Gated Ca²⁺ Channel Ligand — Neuropathic Pain / Epilepsy
GABA analogue chiral intermediate — specification and CoA available on request. Validated API production at cGMP facility.
✓ DMF Available
Anti-Fungal
1 Intermediate
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Voriconazole
Triazole Antifungal — CYP51 Lanosterol 14α-Demethylase Inhibitor
Triazole-based chiral intermediate — full specification available on request
✓ DMF Available
Anti-Migraine
1 Intermediate
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Sumatriptan Succinate
5-HT₁B/₁D Agonist — Selective Serotonin Receptor Agonist / Triptan
4-Hydrazino-n-methane benzene methane sulphonamide HCl [88933-16-8], Sumatriptan Base [103628-46-2]
✓ DMF Available
CEP / KDMF / ANVISA
Anticoagulant
1 Intermediate
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Dabigatran Etexilate Mesylate
Direct Thrombin Inhibitor (DTI) — Oral Anticoagulant
Ethyl 3-(3-amino-4-(methylamino)-N-(pyridin-2-yl)benzamido)propanoate [212322-56-0]
✓ DMF Available
CEP Filing
Anti-Protozoal / Antibacterial
1 Intermediate
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Ornidazole API
5-Nitroimidazole — Antiprotozoal & Anaerobic Antibacterial
1-Chloro-3-(2-methyl-5-nitroimidazol-1-yl)propan-2-ol intermediate — available on request
✓ DMF Available
Dermatology / Hair Restoration
1 Intermediate
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Minoxidil
ATP-Sensitive K⁺ Channel Opener — Antihypertensive / Topical Alopecia
6-(1-piperidinyl)-2,4-pyrimidinediamine 3-oxide intermediate — full CoA available on request
Not Filed
Cognitive / Wakefulness Promoting
1 Intermediate
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Modafinil
Wakefulness-Promoting Agent — Dopamine Reuptake Inhibitor / Narcolepsy
2-[(Diphenylmethyl)sulfinyl]acetamide intermediate — full specification on request
Not Filed
Oncology
1 Intermediate
Product / API
Key Intermediates & CAS Numbers
DMF Status
Filing / Action
Darolutamide Intermediates
Non-Steroidal Androgen Receptor Antagonist (ARi) — Prostate Cancer
4-Bromo-2-Chlorobenzonitrile — key building block for darolutamide synthesis
Not Filed
Patent Notice: Products protected by valid patents are not offered for sale in countries where the sale of such products constitutes a patent infringement and its liability is at buyer's risk. Bio Pharma Primo Impex supplies intermediates strictly for use in jurisdictions where no valid patent protection exists or where applicable compulsory licensing provisions apply.
🏅cGMP Certified
🌐WHO-GMP
🔬CDSCO Approved
📋ISO Certified
🇯🇵PMDA Certified
📄DMF / CEP / KDMF / JDMF / ANVISA Filed
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