API - Guiding you into the safe haven - Pharma Ingredients ...

Guiding you into the safe haven
First-class APIs from
the world leader
Dr. Berit Rabausch,
Hasan Sarica,
two enablers in APIs
Pharma Ingredients & Services. Welcome to more opportunities.
Custom Synthesis | Excipients | Active Ingredients

Superior quality APIs make the difference
“APIs are the backbone of the pharmaceutical industry. Even though some
have become household names in their own right, we never take them
for granted. We’re always looking for new ways to improve our customers’
businesses.” ...
… say Dr. Berit Rabausch, Manager Regulatory Affairs and Hasan Sarica, Manager
Supply Chain. BASF has been dedicated to manufacturing and refining active
pharmaceutical ingredients for over 75 years: longer than anyone else in the
world. But it’s not just about how long we’ve been producing APIs – it’s about
how much our customers trust us to deliver the high-quality products they need,
without fail.
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Trust in BASF competencies
The value of experience
BASF has been developing and refining APIs for over 75 years.
This continuity has helped make us world leaders in generic APIs
like caffeine, ibuprofen, pseudoephedrine and theophylline.
World-class global production facilities
Our global state-of-the-art production technologies, in addition
to our robust and strong quality systems, ensure the consistent
quality and safety of our complete product portfolio. All our production
sites are GMP certified and FDA approved.
Proven consistency and quality
The consistent quality of all our API products is guaranteed by
our validated production processes and documented quality
systems. Our products meet the highest quality standards and
comply with the major pharmacopeias.
Supporting your regulatory needs
Our worldwide presence enables us to support your existing and
new business through our locally based technical and regulatory
experts. We have extensive experience in worldwide registrations,
electronic submissions and life-cycle management of regulatory
documentation.
Optimized logistics for dependable
and reliable supply
As a truly global partner who can also offer reliable local support,
BASF successfully meets industry demands for optimized logistics
networks. With global production centers worldwide and smooth
logistics processes, we can deliver the products you need,
wherever and whenever you need them.
Safety and reliability you can count on
A global partner with local support
Worldwide production facilities for dependable supply
World leader in ibuprofen, coffein, theophylline and pseudoephedrine
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Product listing
• Aminophylline Anhydrous
• Aminophylline Hydrous
• Amylmetacresol (AMC)
• Azelaic Acid 99% (Dermaz 99)
• Benoxinate HCI
• Benzonatate
• Bethanechol Chloride
• Bupivacaine Base
• Bupivacaine HCI
• Caffeine Anhydrous
• Choline Salicylate 80 %
• Dexpanthenol Ph. Eur.
• Dobutamine HCI
• Docosahexaenoic
Acid Ethyl Ester
• Dopamine HCI
• Eicosapentaenoic
Acid Ethyl Ester
• Ephedrine HCI
• Ephedrine Sulphate
• Ibuprofen
• Ibuprofen DC 85 W
• Ibuprofen Sodium
• Racemic Ibuprofen Lysinate
Name Aminophylline Anhydrous Aminophylline Hydrous Amylmetacresol (AMC)
Synonyms /
chemical name
1,3-Dimethylxanthin, compd. with
1,2-ethanediamine (2:1)
1,3-Dimethylxanthin, compd. with
1,2-ethanediamine (2:1) hydrate
2-pentyl-5-methylphenol
CAS no 317-34-0 5897-66-5 1300-94-3
Application
Aminophylline is used in a similar way to theophylline and acts as a
bronchodilator in the management of asthma and chronic obstructive
pulmonary disease. It is also used to relieve apnoea in neonates.
Aminophylline is recommended when exceptional water solubility is
required, particularly in intravenous formulations.
Amylmetacresol is an antiseptic
used to treat minor infections of
the mouth and throat.
Regulatory status USP, Ph. Eur. USP, Ph. Eur., IP Ph. Eur.
Registration EDMF, CEP EDMF, CEP EDMF, CEP
Grades – – –
Packaging 40 kg fiber drums 40 kg fiber drums 4x 2 kg amber-colored glass
bottles in Styropor ® box
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• Isotretinoin M
• Mepivacaine HCI
• Methylphenidate HCI
• Omega-3-Acid Ethyl Ester
• Oxybutynin Base
• Oxybutynin HCI
• Oxymetazoline HCI
• Phenylephrine HCI
• Prilocaine Base
• Prilocaine HCI
• Pseudoephedrin HCI
• Pseudoephedrin Sulphate
• PVP-Iodine 30 / 06
• Retinol 50 PM
• Tetracaine Base
• Tetracaine HCI
• Theophylline Anhydrous
• Theophylline Hydrous
• Tretinoin M
• Xylometazoline HCI
Azelaic Acid 99% (Dermaz 99) Benoxinate HCI Benzonatate Bethanechol Chloride
1,7-heptanedicarboxylic acid
2-(Diethylamino)ethyl-4-amino-
3-butoxybenzoate hydrochloride
p-N-Butylaminobenzoicacid-
(nonaethyleneglycolemethylether)-
ester
(±)-(2-Hydroxypropyl)trimethylammonium
chloride carbamate
123-99-9 5987-82-6 104-31-4 590-63-6
Treating acne vulgaris, inflammatory
rosacea, and hyperpigmentary
disorders.
Local surface anesthetic or
contact anesthetic. It acts on the
neuronal membrane by inhibiting
excitation and conduction.
Secondary pharmacological
properties include antimicrobial
and bacteriostatic effects.
Anti-tussive, non-narcotic,
expectorant and mucolytic of
the benzoate ester type. It acts
peripherally by anaesthetizing
stretch receptors in the respiratory
passages, lungs and pleura,
depressing the cough reflex at
its source.
Cholinergic with muscarinic action
used in urology and to treat certain
intestinal disorders. It mainly acts
in the intestine and bladder.
USP, Ph. Eur. USP USP
USDMF*, EDMF* USDMF, EDMF USDMF USDMF, EDMF
– – –
20 kg fiber drums 20 kg fiber drums 50 kg steel drums inside
fiber drums
50 kg fiber drums
* in preparation, expected during Q1/2014
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Product listing
Name Bupivacaine Base Bupivacaine HCI Caffeine Anhydrous
Synonyms /
chemical name
(±)-1-Butyl-N-(2,6-dimethylphenyl)-
2-piperidinecarboxamide
(±)-1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide
hydrochloride monohydrate
1,3,7-Trimethylxanthine
CAS no 38396-39-3 14252-80-3 58-08-2
Application
Local conduction anesthetic of
the anilide or pipecoloxylidide
type. It acts on the neuronal
membrane by inhibiting excitation
and conduction.
Local conduction anesthetic of
the anilide or pipecoloxylidide
type. It acts on the neuronal
membrane by inhibiting excitation
and conduction.
Among the methylxanthines,
caffeine has the most distinctive
central effect. It primarily acts on
the cerebral cortex and stimulates
psychic and sensory functions.
Caffeine increases mental
receptivity and efficiency and
reduces fatigue.
Regulatory status – USP, Ph. Eur. USP, Ph.Eur., JP, IP
Registration USDMF, EDMF USDMF, CEP EDMF, USDMF, CEP, JDMF
Grades – – Various powder
and granular grades
Packaging 25 kg fiber drums 50 kg fiber drums 25 kg, 50 kg, 100 kg fiber drums
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Choline Salicylate 80 % Dexpanthenol Ph. Eur. Dobutamine HCI Dopamine HCI
(2-Hydroxyethyl)trimethylammonium
salicylate
(R)-2,4-Dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutanamide
4-(2-((3-(4-Hydroxyphenyl)-
1-methylpropyl) amino)ethyl)-1,2-
dihydroxybenzene hydrochloride
2-(3,4-Dihydroxyphenyl)ethylamine
hydrochloride
2016-36-6 81-13-0 49745-95-1 62-31-7
Salicylic acid derivative with
analgesic and anti-inflammatory
properties. Is used in the
management of rheumatic
disorders and in the treatment of
pain, fever and mouth lesions.
Dermaticum, treatment of wounds,
promotion of epithelization.
Dobutamine is used as an infusion
for the treatment of heart failure,
distinct hypotension and shock
conditions.
Dopamine is used as an infusion
for the treatment of heart failure,
distinct hypotension, shock and
imminent kidney failure.
– USP, Ph. Eur. USP, Ph. Eur. USP, Ph. Eur., JP
USDMF, EDMF CEP, EDMF USDMF, EDMF, JDMF, CEP USDMF, EDMF, JDMF, CEP
– – – –
50 kg PE bottles 25 kg steel drums 5 kg, 25 kg fiber drums 5 kg, 20 kg, 25 kg fiber drums
7

Product listing
Name Ephedrine HCI Ephedrine Sulphate Ibuprofen
Synonyms /
chemical name
(1R, 2S)-2-Methylaminophenylpropanol
hydrochloride
(1R, 2S)-2-Methylaminophenylpropanol
sulfate
(±)-2-(p-Isobutylphenyl)propionic
acid
CAS no 50-98-6 134-72-5 15687-27-1
Application
Bronchial asthma, chronic
bronchitis, urticaria, essential
hypotension and related
conditions.
Bronchial asthma, chronic
bronchitis, urticaria. Essential
hypotension and related
circulatory conditions.
Chiral propionic acid derivative,
classified as a nonsteroidal
anti-inflammatory drug (NSAID).
Is used as an analgesic and
antiinflammatory agent.
Regulatory status USP, Ph. Eur. USP USP, Ph. Eur., JP, IP
Registration USDMF, EDMF, CEP EDMF USDMF, EDMF, CEP
Grades – – Ibuprofen 25: Oral liquid suspension
/ topical creams
Ibuprofen 38: Wet granulation
Ibuprofen 50: Wet granulation
Ibuprofen 70: Wet granulation /
dry compression
Packaging 25 kg fiber drums 50 kg fiber drums 50 kg fiber drums
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Ibuprofen DC 85 W Ibuprofen Sodium Racemic Ibuprofen Lysinate Isotretinoin M
(±)-2-(p-Isobutylphenyl)propionic
acid
Sodium-(RS)-2-(4-isobutylphenyl)-
propionate dehydrate
(±)-2-(p-Isobutylphenyl)propionic
acid lysinate
13-Z-Retinoic acid
15687-27-1 31121-93-4 57469-86-8 4759-48-2
Chiral propionic acid derivative, classified as a non-steroidal anti-inflammatory drug (NSAID).
Is used as an analgesic and anti-inflammatory agent.
Treatment of severe forms of acne,
such as acne conglobata and
acne cystica, which are generally
resistant to other forms of
treatment.
– – – USP, Ph. Eur.
USDMF USDMF, EDMF EDMF USDMF, EDMF, CEP
– – – Special particle size upon
customer request
50 kg fiber drums 50 kg fiber drums 25 kg fiber drums 5 kg, 6,25 kg metal drums
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Product listing
Name Maxomega EPA 97 EE* Maxomega DHA 95 EE Maxomega 46/38 EE*
Synonyms /
chemical name
Eicosapentaenoic acid ethyl ester Docosahexaenoic acid ethyl ester Omega-3-acid ethyl ester
CAS no 86227-47-6 73310-11-9 86227-47-6
Application
Eicosapentaenoic acid ethyl ester
therapy in patients with very high
triglyceride levels.
Cardio vascular health, possible
future use in neural and eye
therapies.
Approved for use as cardiovascular
therapy.
Regulatory status JP USP, Ph. Eur.
Registration USDMF, JDMF USDMF 1) USDMF, EDMF, KDMF
Grades – – –
10
Packaging 190 kg lacquered steel drums 190 kg lacquered steel drums 190 kg lacquered steel drums
* Special sales conditions may apply.
1)
Update in preparation

Mepivacaine HCI Methylphenidate HCI Oxybutynin Base Oxybutynin HCI
(±)-N-(2’,6’-Dimethylphenyl)-
1-methyl-2-piperidincarboxamide
hydrochloride
Methyl-α-phenyl-2-
piperidineacetate hydrochloride
butinyl-αphenylcyclohexaneglycolate
butinyl-αphenylcyclohexaneglycolate
hydrochloride
1722-62-9 298-59-9 5633-20-5 1508-65-2
Local conduction anesthetic of the
anilide or pipecoloxylidide type.
It acts on the neuronal membrane
by inhibiting excitation and
conduction.
Central nervous system stimulant
and psychotonic of the piperidine
type. The stimulating effect is the
consequence of an increased
release of dopamine. Is used to
treat children with attention deficit
and hyperactivity disorder (ADHD).
Is a narcotic.
Antis-pasmodic with anti-muscarinic action. Is used to treat urinary
frequency, urgency, incontinence in neurogenic bladder disorders and
nocturnal enuresis. It acts by diminishing frequency and intensity of
bladder contractions, diminishing internal bladder pressure and
increasing its capacity.
USP, Ph. Eur., JP Ph. Eur. USP, Ph. Eur. USP, Ph. Eur.
USDMF, CEP, JDMF EDMF, CEP USDMF, EDMF USDMF, EDMF, CEP, JDMF
– – – –
40 kg fiber drums 50 kg fiber drums 10 kg fiber drums 25 kg fiber drums
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Product listing
Name Oxymetazoline HCI Phenylephrine HCI Prilocaine Base
Synonyms /
chemical name
((4-tert.-butyl-2,6-dimethyl-
3-hydroxy)-benzyl)-imidazoline
hydrochloride
(R)-m-Hydroxy-τ-
(methylaminomethylbenzylalcohol)
hydrochloride
2-(propylamino)-opropionotoluidide
CAS no 2315-02-8 61-76-7 721-50-6
Application
Is a direct-acting sympathomimetic.
It is a vasoconstrictor,
reducing swelling and relieving
nasal congestion when applied to
mucous membranes. It is also
applied as eye drops for the
treatment of non-infected and
allergic, irritated or inflamed
conjunctiva.
For nasal decongestion as tablets,
capsules or sachets, also as nasal
drops or sprays. As mydriatic
or conjuctiva decongestant in
ophthalmology.
Local surface and conduction
anesthetic of the anilide type.
It acts on the neuronal membrane
by inhibiting excitation and
conduction.
Regulatory status USP, Ph. Eur., JP USP, Ph. Eur., JP, IP USP, Ph. Eur.
Registration USDMF, EDMF, JDMF, CEP USDMF, EDMF, CEP USDMF, EDMF, JDMF, CEP
Grades
–
Special particle size upon request
Packaging 1 kg, 5 kg, 10 kg fiber drums 5 kg, 25 kg fiber drums 40 kg fiber drums
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Prilocaine HCI Pseudoephedrine HCI Pseudoephedrine Sulphate PVP-Iodine 30 / 06
2-(Propylamino)-opropionotoluidide
hydrochloride
(1S, 2S)-2-Methylaminophenylpropanol
hydrochloride
(1S, 2S)-2-Methylaminophenylpropanol
sulfate
Polyvinylpyrrolidon iodine
1786-81-8 345-78-8 7460-12-0 25655-41-8
Local surface and conduction
anesthetic or contact anesthetic of
the anilide type. It acts on the
neuronal membrane by inhibiting
excitation and conduction.
Oral decongestant for the treatment
of stuffy noses in common colds
(often associated with rhinitis), and
in allergic rhinitis. Common rhinitis
also provides a favorable breeding
ground for bacterial super-infections,
resulting in sinusitis, otitis
media and pneumonia. Stimulates
the adrenergic receptors in the
smooth vascular muscles in the
nose, constricts the dilated
arterioles of the mucosa, reduces
the blood flow in the nasal mucosa,
and causes the mucosa to contract.
Oral decongestant for the treatment
of stuffy noses in common colds
(often associated with rhinitis), and
in allergic rhinitis. Common rhinitis
also provides a favorable breeding
ground for bacterial super-infections,
resulting in sinusitis, otitis
media and pneumonia. Stimulates
the adrenergic receptors in the
smooth vascular muscles in the
nose, constricts the dilated
arterioles of the mucosa, reduces
the blood flow in the nasal mucosa,
and causes the mucosa to contract.
Prophylaxis of skin and mucous
membrane antisepsis and surgical
and hygienic hand disinfection.
Treatment of burns, decubitus,
varicose ulcers, dermatomycosis,
pyoderma, acne and vaginitis.
PVP iodine is used as a disinfectant
in topical formulations such as
solutions, ointments, creams,
ovula and others. It is also applied
in gargle solutions, surgical
scrubs, in soaps and shampoos.
USP, Ph. Eur. USP, Ph. Eur., JPC, IP USP USP, Ph. Eur., JP, IP
USDMF, EDMF, JDMF, CEP USDMF, EDMF, CEP USDMF, EDMF USDMF, EDMF
– crystalline and powder grades,
special particle size upon request
crystalline and powder grades,
special particle size upon request
50 kg fiber drum 5 kg, 25 kg, 50 kg fiber drums 5 kg, 50 kg fiber drums 70 kg PE drums,
500 kg super sacks
–
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Product listing
Name Retinol 50 PM Tetracaine Base Tetracaine HCI
Synonyms /
chemical name
Vitamin A alcohol ethyl-p-(butylamino)benzoate ethyl-p-ethyl-p-(butylamino)
benzoate hydrochloride
CAS no 68-26-8 94-24-6 136-47-0
Application
Retinol 50 PM is a 50 % solution
of vitamin A in Polysorbate 20.
It is used mainly for topical
preparations like skin creams,
nasal oils and various ophthalmic
formulations. It improves the
healing of damaged skin, nasal
mucosa and cornea/conjunctiva.
Local surface, conduction and infiltration anesthetic or contact
anesthetic of the benzoate ester type. It acts on the neuronal
membrane by inhibiting excitation and conduction.
Regulatory status USP, Ph. Eur. USP USP, Ph. Eur., JP
Registration – USDMF, EDMF USDMF, EDMF, JDMF
Grades
–
– –
Packaging 1 kg aluminum bottle 50 kg fiber drums 50 kg fiber drums
14

Specifications
See separate document:
“Standard Specification (not for
regulatory purposes)” available
via BASF’s WorldAccount:
https://worldaccount.basf.com
(registered access)
Regulatory package
See separate document:
“Q & RPI” available via BASF’s
WorldAccount:
https://worldaccount.basf.com
(registered access)
Theophylline Anhydrous Theophylline Hydrous Tretinoin M Xylometazoline HCI
1,3-Dimethylxanthine
1,3-Dimethylxanthine
monohydrate
all-trans-Retinoic acid
((4-tert.-butyl-2,6-dimethyl)-
benzyl)-imidazoline hydrochloride
58-55-9 5967-84-0 302-79-4 1218-35-5
Standard treatment for bronchial
asthma, chronic obstructive
airway disease, status asthmaticus,
bronchial emphysema and
shortness of breath caused by
right-side heart failure due to
obstructive pulmonary disease.
Standard treatment for bronchial
asthma, chronic obstructive
airway disease, status asthmaticus,
bronchial emphysema and
shortness of breath caused by
right-side heart failure due to
obstructive pulmonary disease.
Treatment of acne (acne vulgaris
and keratosis pilaris).
Is a direct-acting sympathomimetic.
It is a vasoconstrictor,
reducing swelling and relieving
nasal congestion when applied to
mucous membranes. It is also
applied as eye drops for the
treatment of non-infected and
allergic, irritated or inflamed
conjunctiva.
USP, Ph. Eur., JP, IP USP, Ph. Eur., JP, IP USP, Ph. Eur. USP, Ph. Eur., IP
USDMF, EDMF, CEP, JDMF USDMF, EDMF, CEP USDMF, EDMF, CEP USDMF, EDMF, CEP
crystalline and powder grades crystalline and powder grades – –
25 kg, 50 kg fiber drums,
400 kg IBC
25 kg , 50 kg fiber drums,
400 kg IBC
0.1 kg, 0.43 kg aluminum cans 1 kg PE bottles,
1 kg, 5 kg, 10 kg fiber drums
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APIs you can count on
• Proven and consistent safety and reliability
• Global reach with local service support
• Production facilities worldwide for fast, reliable supply
• World leader in generic APIs, with 75 years of experience
Our outstanding research and development facilities are matched by our global customer
service and support networks. You can depend on us every step of the way in developing
commercially and clinically successful pharmaceutical products.
Contact us to find out how Dr. Berit Rabausch, Hasan Sarica and their colleagues
can help you boost the effectiveness of your APIs.
North America
SangJun Lee
USA
Phone: +1 973 245 6381
Asia / Pacific
Monwida Intarasonti
Hong Kong
Phone: +852 2731 7059
South America
Alejandro Welsh
Argentina
Phone: +54 11 4317 9725
Europe
Ursula Gieger
Germany
Phone: +49 621 60 76919
pharma-ingredients@basf.com
www.pharma-ingredients.basf.com
03_110605e-03
Disclaimer
The data contained in this publication are based on our current knowledge and experience. In view of the many factors
that may affect processing and application of our product, these data do not relieve processors from carrying out their own
investigations and tests; neither do these data imply any guarantee of certain properties, nor the suitability of the product
for a specific purpose. Any descriptions, drawings, photographs, data, proportions, weights etc. given herein may change
without prior information and do not constitute the agreed contractual quality of the product. It is the responsibility of the
recipient of our products to ensure that any proprietary rights and existing laws and legislation are observed. (10/2011)
® = registered trademark of BASF SE