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Your Health isOur Passion!
APIs and Intermediates catalogue
Company Profile• Located 25 km of Riga, Latvia• Company established in 1972 • Olainfarm is an innovative manufacturer of Finished dosage forms, Original and Generic APIs, API
intermediates, Specialty organic chemicals• Site area 430 000 sq. meter, multipurpose plant• Full cGMP compliance• Products offered in gram to tons quantities
Research and Development• Synthetic route scouting• Technology optimization/upscale• Development and Validation of analytical methods• Determination and characterization of impurities• Degradation studies and stability testing
Our Chemistry Know-how• Quinuclidine chemistry• Adamantane chemistry• Chiral amino acids• Hydrogenations• Handling of hazardous chemicals• Metalorganic chemistry
Contract Manufacturing• APIs and Intermediates manufacturing
We offer full cycle API and Intermediates development/upscale/manufacturing under cGMP
QC/QA and Regulatory Documentation Support• Compilation of Active Substance Master File (ASMF) and Dossiers in CTD and eCTD formats• Qualification and Validation (facility, equipment and process validation)• Conducting internal audits as part of self-inspection program to ensure compliance to GMP standards
and also vendor audits• Preparation of Quality Reviews (PQR)• Change control, deviation investigation and handling of market complaints • QC of Raw materials, in-process samples and finished products
Equipment1. HPLC/UPLC (UV, MS, LSD, RI) 2. GC, GC-MS3. Particle size analysis4. IR, UV, Optical rotation, mp, XRPD, NMR5. Solubility determination6. Automatic titrators
Kilo Lab/Pilot plant/Production plant• Plant area — 45000 sq. meters• Operating volume — 219 000 liters• Operating temperature — -10 to +200 deg. C (-50 to +200 deg. C for the Kilo lab)• Operating vaccum — 3–5 mBar
No. Chemical name Structural formula Molecular formula
Key use StageCAS No.
1. 1– Adamantyl methyl ketone(1– Acetyladamantane)
C12H18O Rimantadine hydrochloride
C[1660 – 04 – 4]
Adamantane derivatives
Intermediates
2. 2 – Adamantanone C10H14O C[700 – 58 – 3]
3. 2 – Adamantanol(2 – Hydroxyadamantane)
C10H16O P[700 – 57 – 2]
4. 1,3 – Dimethyladamantane C12H20 C[702 – 79 – 4] Memantine hydrochloride
6. 3 – Amino – 1 – hydroxy – adamantane
C10H17NO C[702 – 82 – 9] Vildagliptin
9. 1 – Chloro – 3,5 – dimethyladamantane
C12H19Cl C[707 – 36 – 8] Memantine hydrochloride
10. 1 – Hydroxy – 3,5 – dimethyladamantane
C12H20O C[707 – 37 – 9] Memantine hydrochloride
15. 1 – Acetylamido – 3,5 – dimethyladamantane
C14H23NO L[19982 – 07 – 1] Memantine hydrochloride
17. (2S) – [(tert – Butoxycarbonyl)amino](3 – hydroxyadamant – 1 – yl)ethanoic acid
C17H27NO5 L[361442 – 00 – 4] Saxagliptin
14. 1 – Adamantaneethanol[2 – (1 – Adamantylethanol)]
C12H20O P[6240 – 11 – 5]
13. 1 – Adamantanemethanol(1 – Adamantylmethanol)
C11H18O P[770 – 71 – 8]
12. 1 – Adamantaneacetic acid(1 – Adamantylacetic acid)
C12H18O2 P[4942 – 47 – 6]
11. 1,3 – Dihydroxyadamantane(1,3 – Adamantanediol)
C10H16O2 L[5001 – 18 – 3]
8. 1 – Acetylamidoadamantane C12H19NO L[880 – 52 – 4]
7. N – (2 – Adamantyl) – N – (4 – bromophenyl)amine
C16H20BrN P[87913 – 26 – 6]
5. 2 – Aminoadamantane hydrochloride
C10H17N .
HCl P[10523-68-9]
16. 3 – (Hydroxy – methyl)adamant – 1 – ol
C11H18O2 L[38584 – 37 – 1]
CH3
O
CH3
CH3
NH2
ClH
NH
Br
NHCH3
O
CH3 CH3
Cl
CH3 CH3
OH
NHCH3
CH3
CH3
O
OH
OH
O
NHBoc
O
OH
NH2
OH
OH
OH
OH
O
OH
OH
OH
OH
No. Chemical name Structural formula Molecular formula
Key use StageCAS No.
18. Dimethyl-5-hydroxy-1,3-Adamantane dicarboxylate
C14H20O5 P[213274-64-7]
Adamantane derivatives
Intermediates
19. S-Rimantadine C12H21N P[887336-06-3]
20. R-Rimantadine C12H21N P[887336-05-2]
OH
COOMeMeOOC
CH3NH2
CH3NH2
1. 1 – Aminohydantoin hydrochloride C3H5N3O2 ⋅ HCl C[2827 – 56 – 7] Dantrolene Nitrofurantoin
No. Chemical name Structural formula Molecular formula
Key use StageCAS No.
Miscellaneous
NHN
O
O
NH2 • HCl
C – Commercial, P – Pilot, L – Laboratory
No. Chemical name Structural formula Molecular formula
Key use StageCAS No.
1. 3-Quinuclidinone hydrochloride
C7H11NO .
HCl Aceclidine Azasetron Cevimeline Clidinium MequitazineQuifenadine
C[1193
[50790-85-7]
– 65 – 3]
Quinucilidine derivatives
Intermediates
2. 3-Carbethoxy-dehydro-quinuclidine hydrochloride
C10H15NO2.
HCl C
3. 3-Carbethoxyquinuclidine C10H17NO2 C[6238 – 33 – 1]
4. 3-Quinuclidinol C7H13NO C[1619 – 34 – 7] AceclidineClidiniumQuinupramineAclidinium
Quifenadine
6. R – ( – ) – 3 – Quinuclidinolee 99.9%
C7H13NO C[25333 – 42 – 0] SolifenacinAclidinium
9. S – ( – ) – 3 – Aminoquinuclidine dihydrochlorideee 99.5%
C7H14N2 .
2HCl C[119904 – 90 – 4] Palonosetron
10. 3 – Quinuclidine carboxylic acid hydrochloride
C8H13NO2 .
HCl L[6238-34-2]
[79221-75-3]
Free base[138874-55-2]
Free base[88644-21-7]
[865887-14-5]
15. S-3-aminomethyl-quinuclidine dihydrochloride
C8H16N2 .
2HCl L
14. 3-aminomethyl-quinuclidine dihydrochloride
C8H16N2 .
2HCl L
13. S-3-hydroxymethyl quinuclidine hydrochloride
C8H15NO .
HCl L
12. R-3-hydroxymethyl quinuclidine hydrochloride
C8H15NO .
HCl L
11. 3-hydroxymethyl quinuclidine hydrochloride
C8H15NO .
HCl L
8. R – (+) – 3 – Aminoquinuclidine dihydrochlorideee up to 99.5%
C7H14N2 .
2HCl C[123536 – 14 – 1]
7. 3 – Aminoquinuclidine dihydrochloride
C7H14N2 .
2HCl C[6530 – 09 – 2]
5. S – (+) – 3 – Quinuclidinolee 99.5%
C7H13NO C[34583 –34–1]
16. R-3-aminomethyl-quinuclidine dihydrochloride
C8H16N2 .
2HCl L
N
O
• HCl
N
OH
N
OH
N
OH
N
NH2
• 2HCl
N
NH2
• 2HCl
N
NH2
• 2HCl
N
COOH
• HCl
N
OH• HCl
N
OH• HCl
N
OH• HCl
N
NH2
• 2HCl
N
NH2
• 2HCl
N
NH2
• 2HCl
C – Commercial, P – Pilot, L – Laboratory
N
O
OEt• HCl
N
O
OEt
Drug substances (APIs):
No. Product Therapeutic category Pharmacopoeia StageCAS No.
C – Commercial, P – Pilot, L – Laboratory® - Registered Trademark in Republic of Latvia
Generics
1. Amantadine hydrochloride(ASMF available)
Antiviral (Influenza A); antiparkinsonian; treatment of drug-induced extrapyramidal reactions
Ph, Eur.USP
[665 – 66 – 7] C
2. Amantadine sulphate Antiviral (Influenza A); antiparkinsonian Non – pharmacopoeial
[31377 – 23 – 8] P
3. Anagrelide hydrochloride(ASMF available)
Platelet-reducing agent USP [58579 – 51 – 4] C
4. Chlorobutanol hemihydrate (ASMF and CEP available)
Analgesic (dental) Ph. Eur. (CEP) [6001 – 64 – 5] C
5. Furazidin (Furagin®)(ASMF available)
Antimicrobials Non – pharmacopoeial
[1672 – 88 – 4] C
6. Memantine hydrochloride(ASMF available)
Anti-Dementia Drug USP [41100 – 52 – 1] C
7. Nitrofurantoin monohydrate(ASMF available)
AntibacterialVet: Antibacterial
USP [17140 – 81 – 7] [monohydrate]
C
8. Nitrofurantoin Macrocrystalline(ASMF in development)
AntibacterialVet: Antibacterial
USP [67 – 20 – 9] [anhydrous]
C
9. Phenazepam(ASMF in development)
Tranquillisers Non – pharmacopoeial
[51753 – 57 – 2] C
10. Rimantadine hydrochloride(ASMF available)Pure enantiomers available
Antiviral USP [1501 – 84 – 4] [hydrochloride]; [13392 – 28 – 4] [base]
C
11. Thalidomide(ASMF available)
All other antineoplastics USP [50 – 35 – 1] C
12. Lenalidomide(ASMF available)
All other antineoplastics Non – pharmacopoeial
[191732 – 72 – 6][base]
C
13. Lenalidomide Hydrochloride(ASMF available)
All other antineoplastics Non – pharmacopoeial
[1243329 – 97 – 6] P
14. R-(+)-Phenibut Non – pharmacopoeial
[35568 – 36 – 6] P
15. R-Phenylpiracetam Non – pharmacopoeial
[949925 – 07 – 9] P
17. R-Baclofen(Technical package available)
Non – pharmacopoeial
[69308 – 37 – 8] C
No. INN Therapeutic category Structural formula ASMF available
CAS No.
1. CevimelineHydrochloride
And free base
Q4 2015[153504-70-2][107233 – 08 – 9]
[274901 – 16 – 5]
In development
Drug substances (APIs):
2. Vildagliptin Q2 2015
3. Saxagliptin Q2 2016[361442 – 04 – 8]
4. Glycopyrrolatebromide
Q2 2016[596 – 51 – 0]
5. Ivabradine hydrochloride
Antianginal
ATC: C01EB17
Antispasmodic; Anticholinergic; Antimuscarinic
ATC: A03AB02
Antidiabetic
ATC: A10BH03
Antidiabetic
ATC: A10BH02
Parasympatho – mimetic
ATC: N07AX03
Q2 2016[148849 – 67 – 6]
6. Aclidinium bromide Bronchodilator
ATC: R03BB05and R03AL05
2017[320345-99-1]
7. Umeclidinium Bromide Bronchodilator
ATC: R03BB07 and R03AL03
2017[869113-09-7]
8. Pomalidomide All other antineoplastics
ATC: L04AX
Q4 2015[19171 – 19 – 8]
N
O
ON
OO
O
• HCl
N
NH
O
O
O
O
NH2
9.
S
O
N• HCl
NH2
NO
HH
CN
OH
N+
O
O
S
SOH
O Br
Apremilast Antipsoriatic
ATC: L04AA32
2017[608141-41-9]
N
O
ONH
O
S
O
O
O
O
OH
NH
N
O
CNH
N+
O
OH
Br
O
O
OH
N+ Br
Address: 5 Rupnicu Street, Olaine, LV-2114, LatviaPhone: (+371) 67013705Fax: (+371) 67013777E-mail: [email protected]
www.olainfarm.com
Certificates• EU GMP for APIs and FDFs• US cGMP for certain APIs (FDA)• TGA for FDFs (Australia)• ISO 14001 Environmental Management System• ISO 17025 Laboratory Management System
YOUR HEALTH IS OUR PASSION SINCE 1972Olainfarm is the leading manufacturer in the chemical and pharmaceutical sector of the Baltic States with more than 40 years of experience.
Export to more than 40 countries