Your Health is Our 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

Equipment 1. HPLC/UPLC (UV, MS, LSD, RI) 2. GC, GC-MS 3. Particle size analysis 4. IR, UV, Optical rotation, mp, XRPD, NMR 5. Solubility determination 6. 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

Intermediates Adamantane derivatives No.

Chemical name

1.

1– Adamantyl methyl ketone (1– Acetyladamantane)

2.

2 – Adamantanone

3.

2 – Adamantanol (2 – Hydroxyadamantane)

4.

1,3 – Dimethyladamantane

Structural formula

O

Molecular formula

CAS No.

Key use

Stage

C12H18O

[1660 – 04 – 4]

Rimantadine hydrochloride

C

C10H14O

[700 – 58 – 3]

C

C10H16O

[700 – 57 – 2]

P

C12H20

[702 – 79 – 4]

C10H17N . HCl

[10523-68-9]

C10H17NO

[702 – 82 – 9]

C16H20BrN

[87913 – 26 – 6]

P

C12H19NO

[880 – 52 – 4]

L

C12H19Cl

[707 – 36 – 8]

Memantine hydrochloride

C

C12H20O

[707 – 37 – 9]

Memantine hydrochloride

C

C10H16O2

[5001 – 18 – 3]

L

C12H18O2

[4942 – 47 – 6]

P

C11H18O

[770 – 71 – 8]

P

C12H20O

[6240 – 11 – 5]

P

C14H23NO

[19982 – 07 – 1]

C11H18O2

[38584 – 37 – 1]

C17H27NO5

[361442 – 00 – 4]

CH3

O

OH

CH3

Memantine hydrochloride

C

CH3

5.

2 – Aminoadamantane hydrochloride

6.

3 – Amino – 1 – hydroxy – adamantane

NH2 HCl

NH2

P

Vildagliptin

C

OH

7.

NH

N – (2 – Adamantyl) – N – (4 – bromophenyl)amine

Br

8.

O

1 – Acetylamidoadamantane

CH3

NH

9.

Cl

1 – Chloro – 3,5 – dimethyladamantane H3C

10.

CH3 OH

1 – Hydroxy – 3,5 – dimethyladamantane

CH3

H3C

11.

OH

1,3 – Dihydroxyadamantane (1,3 – Adamantanediol)

OH

12.

O

1 – Adamantaneacetic acid (1 – Adamantylacetic acid)

13.

1 – Adamantanemethanol (1 – Adamantylmethanol)

14.

1 – Adamantaneethanol [2 – (1 – Adamantylethanol)]

15.

1 – Acetylamido – 3,5 – dimethyladamantane

OH

OH

OH

CH3 O NH

H3C

16.

17.

(2S) – [(tert – Butoxycarbonyl)amino](3 – hydroxyadamant – 1 – yl)ethanoic acid

L

CH3

OH

3 – (Hydroxy – methyl)adamant – 1 – ol

Memantine hydrochloride

L

OH

OH O OH NHBoc

Saxagliptin

L

Intermediates Adamantane derivatives No.

Chemical name

18.

Dimethyl-5-hydroxy1,3-Adamantane dicarboxylate

19.

S-Rimantadine

20.

R-Rimantadine

Structural formula OH

Molecular formula

CAS No.

Key use

Stage

C14H20O5

[213274-64-7]

P

C12H21N

[887336-06-3]

P

C12H21N

[887336-05-2]

P

Molecular formula

CAS No.

Key use

Stage

C3H5N3O2 ⋅ HCl

[2827 – 56 – 7]

Dantrolene Nitrofurantoin

C

COOMe

MeOOC

H2N

CH3

H2N

CH3

Miscellaneous No.

Chemical name

1.

1 – Aminohydantoin hydrochloride

Structural formula O H2N

N

NH

• HCl

O

C – Commercial, P – Pilot, L – Laboratory

Intermediates Quinucilidine derivatives No.

Chemical name

1.

3-Quinuclidinone hydrochloride

Structural formula

Molecular formula

CAS No.

Key use

Stage

C7H11NO . HCl

[1193 – 65 – 3]

Aceclidine Azasetron Cevimeline Clidinium Mequitazine Quifenadine

C

C10H15NO2. HCl

[50790-85-7]

C10H17NO2

[6238 – 33 – 1]

Quifenadine

C

OH

C7H13NO

[1619 – 34 – 7]

Aceclidine Clidinium Quinupramine Aclidinium

C

OH

C7H13NO

[34583 – 34 – 1]

OH

C7H13NO

[25333 – 42 – 0]

C7H14N2 . 2HCl

[6530 – 09 – 2]

C

C7H14N2. 2HCl

[123536 – 14 – 1]

C

C7H14N2. 2HCl

[119904 – 90 – 4]

C8H13NO2 . HCl

[6238-34-2]

L

C8H15NO . HCl

[79221-75-3]

L

C8H15NO . HCl

Free base [138874-55-2]

L

C8H15NO . HCl

Free base [88644-21-7]

L

C8H16N2 . 2HCl

[865887-14-5]

L

O • HCl N

2.

O

3-Carbethoxy-dehydroquinuclidine hydrochloride

C

OEt • HCl N

3.

O

3-Carbethoxyquinuclidine

OEt N

4.

3-Quinuclidinol N

5.

6.

S – (+) – 3 – Quinuclidinol ee 99.5%

C

N

R – ( – ) – 3 – Quinuclidinol ee 99.9%

Solifenacin Aclidinium

C

N

7.

3 – Aminoquinuclidine dihydrochloride

NH2 • 2HCl N

8.

9.

10.

R – (+) – 3 – Aminoquinuclidine dihydrochloride ee up to 99.5%

NH2 • 2HCl N

S – ( – ) – 3 – Aminoquinuclidine dihydrochloride ee 99.5%

NH2

Palonosetron

C

• 2HCl N

3 – Quinuclidine carboxylic acid hydrochloride

COOH • HCl N

11.

3-hydroxymethyl quinuclidine hydrochloride

OH • HCl N

12.

R-3-hydroxymethyl quinuclidine hydrochloride

OH • HCl N

13.

S-3-hydroxymethyl quinuclidine hydrochloride

OH • HCl N

14.

3-aminomethyl-quinuclidine dihydrochloride

NH2 • 2HCl N

15.

S-3-aminomethyl-quinuclidine dihydrochloride

NH2 • 2HCl

C8H16N2. 2HCl

L

C8H16N2 . 2HCl

L

N

16.

R-3-aminomethyl-quinuclidine dihydrochloride

NH2 • 2HCl N

C – Commercial, P – Pilot, L – Laboratory

Drug substances (APIs): Generics No.

Product

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)

Antibacterial Vet: Antibacterial

USP

[17140 – 81 – 7] [monohydrate]

C

8.

Nitrofurantoin Macrocrystalline (ASMF in development)

Antibacterial Vet: 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

®

Therapeutic category

- Registered Trademark in Republic of Latvia

Pharmacopoeia

CAS No.

Stage

C – Commercial, P – Pilot, L – Laboratory

Drug substances (APIs): In development No.

INN

Therapeutic category

1.

Cevimeline Hydrochloride

Parasympatho – mimetic

Structural formula

O

ATC: N07AX03

S

And free base

CAS No.

ASMF available

[153504-70-2] [107233 – 08 – 9]

Q4 2015

[274901 – 16 – 5]

Q2 2015

[361442 – 04 – 8]

Q2 2016

[596 – 51 – 0]

Q2 2016

[148849 – 67 – 6]

Q2 2016

[320345-99-1]

2017

[869113-09-7]

2017

[19171 – 19 – 8]

Q4 2015

[608141-41-9]

2017

• HCl

N

2.

Vildagliptin

Antidiabetic

H N

ATC: A10BH02

O

HO

N N C

3.

Saxagliptin

Antidiabetic

N NH2 C

HO

Glycopyrrolate bromide

N

Antispasmodic; Anticholinergic; Antimuscarinic

OH

ATC: A03AB02

5.

Ivabradine hydrochloride

H

O

ATC: A10BH03

4.

H

H

O

O

N

Br

+

Antianginal

O

ATC: C01EB17

N

N

O

O

O

• HCl O

6.

Aclidinium bromide

Bronchodilator

S

ATC: R03BB05 and R03AL05 N

Umeclidinium Bromide

S

O

+

Br

O

7.

OH

O

Bronchodilator

OH

ATC: R03BB07 and R03AL03 N

+

O

8.

Pomalidomide

All other antineoplastics

NH2

Br

O

ATC: L04AX O

N NH O

9.

Apremilast

O

Antipsoriatic

O

O S O

ATC: L04AA32

N NH O

O

O O

YOUR HEALTH IS OUR PASSION SINCE 1972 Olainfarm is the leading manufacturer in the chemical and pharmaceutical sector of the Baltic States with more than 40 years of experience.

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

Export to more than 40 countries

Address: 5 Rupnicu Street, Olaine, LV-2114, Latvia Phone: (+371) 67013705 Fax: (+371) 67013777 E-mail: [email protected] www.olainfarm.com