Draft Stability Testing of Active Pharmaceutical Ingredients and Pharmaceutical Product
cGMP produced commercial active pharmaceutical ingredients
2
Albemarle enjoys a long history of supplying high-quality active pharmaceutical ingredients (APIs) to the ethical and generic pharmaceutical markets. Why partner with us? For all the right reasons: • Our U.S.-manufactured APIs adhere to strict cGMP requirements, backed by our excellent regulatory record • We support you with technical service, regulatory information, and guidance, as needed, for efficient and effective use of our APIs • We maintain an active, ongoing program to develop new APIs • We draw upon a wide range of expertise and capabilities, ranging from samples to large-volume production, for use in all forms of drug products (oral and injectable) Want to learn more or view a complete, current API list? Just let us know. Amifostine Cytoprotective adjuvant Benazepril HCI ACE Inhibitor Benzonatate, USP Cough suppressant Diphenhydramine Citrate, USP Sleep aid, antihistamine Fenoprofen Calcium, USP Analgesic, anti-inflammatory Flurbiprofen, USP & BP Analgesic, anti-inflammatory Ibuprofen, USP & Ph.Eur. Anti-inflammatory, analgesic Ibuprofen Sodium, USP Anti-inflammatory, analgesic Itraconazole Antifungal Ketoconazole, USP Antifungal Lidocaine HCI, USP & BP Topical anesthetic, inj. Anti-arrhythmic Lidocaine, USP, BP & Ph.Eur. Topical anesthetic Meclofenamate Sodium, USP Analgesic, anti-inflammatory Milrinone Cardiotonic Orphenadrine Citrate, USP & BP Muscle relaxant p-Aminohippuric Acid, USP Renal function diagnostic Procainamide HCI, USP, BP & Ph.Eur. Anti-arrhythmic Propranolol HCI, USP & BP Anti-arrhythmic, anti-adrenergic Propofol, USP & Ph.Eur. Injectable anesthetic Terconazole Topical antifungal Tetracaine HCI, USP & BP Topical anesthetic Tetrahydrozoline HCI, USP Vasoconstrictor ALBEMARLE ACTIVE GENERIC INDICATION ALBEMARLE ACTIVE GENERIC INDICATION cGMP-produced commercial active pharmaceutical ingredients cGMP-produced commercial active pharmaceutical ingredients
-
Upload
albemarle-fine-chemistry-services -
Category
Technology
-
view
5.882 -
download
1
Transcript of cGMP produced commercial active pharmaceutical ingredients
Albemarle enjoys a long history of supplying high-quality active
pharmaceutical ingredients (APIs) to the ethical and generic pharmaceutical markets.
Why partner with us? For all the right reasons:
• Our U.S.-manufactured APIs adhere to strict cGMP requirements, backed by our excellent regulatory record
• We support you with technical service, regulatory information, and guidance, as needed, for efficient and effective use of our APIs
• We maintain an active, ongoing program to develop new APIs
• We draw upon a wide range of expertise and capabilities, ranging from samples to large-volume production, for use in all forms of drug products (oral and injectable)
Want to learn more or view a complete, current API list? Just let us know.
Amifostine Cytoprotective adjuvant
Benazepril HCI ACE Inhibitor
Benzonatate, USP Cough suppressant
Diphenhydramine Citrate, USP Sleep aid, antihistamine
Fenoprofen Calcium, USP Analgesic, anti-inflammatory
Flurbiprofen, USP & BP Analgesic, anti-inflammatory
Ibuprofen, USP & Ph.Eur. Anti-inflammatory, analgesic
Ibuprofen Sodium, USP Anti-inflammatory, analgesic
Itraconazole Antifungal
Ketoconazole, USP Antifungal
Lidocaine HCI, USP & BP Topical anesthetic, inj. Anti-arrhythmic
Lidocaine, USP, BP & Ph.Eur. Topical anesthetic
Meclofenamate Sodium, USP Analgesic, anti-inflammatory
Milrinone Cardiotonic
Orphenadrine Citrate, USP & BP Muscle relaxant
p-Aminohippuric Acid, USP Renal function diagnostic
Procainamide HCI, USP, BP & Ph.Eur. Anti-arrhythmic
Propranolol HCI, USP & BP Anti-arrhythmic, anti-adrenergic
Propofol, USP & Ph.Eur. Injectable anesthetic
Terconazole Topical antifungal
Tetracaine HCI, USP & BP Topical anesthetic
Tetrahydrozoline HCI, USP Vasoconstrictor
ALBEMARLE ACTIVE GENERIC INDICATION ALBEMARLE ACTIVE GENERIC INDICATION
cGMP-produced commercial active pharmaceutical ingredients
cGMP-produced commercial active pharmaceutical ingredients
The information presented herein is believed to be accurate and reliable, but is presented without guarantee or responsibility on the part of Albemarle Corporation. It is the responsibility of the user to comply with all applicable laws and regulations and to provide for a safe workplace. The user should consider any information contained herein, including information about any health or safety hazards, only as a guide, and should take those precautions that are necessary or prudent to instruct employees and to develop work practice procedures in order to promote a safe work environment. Further, nothing contained herein shall be taken as an inducement or recommendation to manufacture or use any of the herein described materials or processes in violation of existing or future patents.
Find out how we say yes to hundreds of fine chemistry projects annually.
Albemarle is experienced and equipped to provide high-quality APIs to pharmaceutical customers worldwide.
To experience the difference of a committed fine chemistry partner, contact your Albemarle Representative.
www.albemarle.com
A M E R I C A S
Fine Chemistry Services
Tel: +1 225 388 7402
E U RO PE , M I D D L E E A ST, A F R I C A
EMA Fine Chemistry Services
Tel: +32 10 48 1711
FCS-0002 (01/11)
