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Gemcitabine  Hydrochloride is an analogue of cytarabine (Cytarabine) that is metabolized intracellular to active diphosphate and triphosphate nucleosides, which inhibit DNA synthesis and induce apoptosis. It is primarily active against cells in S phase. It is given in the management of solid tumors including those of the bladder, breast, lung, ovary, and pancreas.

• Korean patent number 0704213 on Atorvastatin Hemi Calcium crystalline form VII.
• Korean patent number 0765871 on Atorvastatin  Hemi Calcium crystalline forms VI, VIII, IX, X, XI, XII and pharmaceutical composition thereof and process for preparing crystalline forms I, II, IV and V and amorphous form.
• Korean patent number 0724515 on Atorvastatin Hemi Calcium crystalline forms IX, IXa, XIV, XVI, XVII.

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Eptifibatide (Integrilin®, Millennium Pharmaceuticals, also co-promoted by Schering-Plough/Essex), is an antiplatelet drug that selectively blocks the platelet glycoprotein IIb/IIIa receptor. Eptifibatide is a cyclic heptapeptide derived from a protein found in the venom of the southeastern pygmy rattlesnake (Sistrurus miliarus barbouri). It belongs to the class of the so called arginin-glycin-aspartat-mimetics and reversibly binds to platelets. Eptifibatide has a short half-life. The drug is the third inhibitor of GPIIb/IIIa that has found broad acceptance after the specific antibody abciximab and the non-peptide tirofiban entered the global market.

Integrilin® is sold in two strengthes: vials containing 2 mg/ml (20 mg totally) and 0.75 mg/ml (75 mg totally).

Eptifibatide is used to reduce the risk of acute cardiac ischemic events (death and/or myocardial infarction) in patients with unstable angina or non-ST-segment-elevation (e.g., non-Q-wave) myocardial infarction (i.e., non-ST-segment elevation acute coronary syndromes) both in patients who are to receive non surgery (conservative) medical treatment and those undergoing percutaneous coronary intervention (PCI).

Exenatide (marketed as Byetta®) is the first of a new class of medications (incretin mimetics) approved for the treatment of type 2 diabetes. It is manufactured and marketed by Amylin Pharmaceuticals and Eli Lilly and Company. Exenatide is a synthetic version of exendin-4, a hormone in the saliva of the Gila monster, a lizard native to several Southwestern American states. It displays properties similar to human GLP-1.

Exenatide is a 39 amino acid peptide that mimics the GLP-1 incretin, an insulin secretagogue with glucoregulatory effects. While it may lower blood glucose levels on its own, it can also be combined with other medications such as pioglitazone, metformin, sulfonylureas, and/or insulin to improve glucose control. The approved use of exenatide is with either sulfonylureas, metformin and thiazolinediones. The medication is injected twice per day (s.c) using a pre-filled pen device.

Solifenacin (rINN), marketed as solifenacin succinate under the trade name VESIcare®, marketed by Astellas and GSK is a urinary antispasmodic of the anticholinergic class. It is used in the treatment of overactive bladder with or without urge incontinence.

Solifenacin is a competitive muscarinic acetylcholine receptor antagonist. The binding of acetylcholine to these receptors, particularly the M3 receptor subtype, plays a critical role in the contraction of smooth muscle. By preventing the binding of acetylcholine to these receptors, solifenacin reduces smooth muscle tone in the bladder, allowing the bladder to retain larger volumes of urine and reducing the number of micturition, urgency and incontinence episodes. Thanks to a long elimination half life, once-a-day dose can offer 24 hour control of the urinary bladder smooth muscle tone.

*Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute an offer for sale in territories where it is not permitted by law.

The inspections were in the following plants: 
• Teva Pharmaceutical Fine Chemicals S.r.l.- Settimo, Bulciago and Villanterio locations in Italy
• Sicor - Societa Italiana Corticosteroidi, SpA-Santhia and Rho locations in Italy
• Abic Ltd. in Israel
• Teva Pharmaceutical Works in Hungary
• Sicor De Mexico, S.A. de C.V. in Mexico
• API Industries TAPI Puerto Rico Inc. in Puerto Rico-USA
• Sicor Europe, S.A. in Vocallo, Switzerland

Candesartan is an angiotensin II receptor antagonist with actions similar to those of losartan (Losartan Potassium). It is used in the management of hypertension and may also be used in heart failure in patients with impaired left ventricular systolic function, either when ACE inhibitors are not tolerated, or in addition to ACE inhibitors. Candesartan Cilexetil marketed by AstraZeneca as ATACAND , a prodrug which hydrolyzed to candesartan during absorption from the gastrointestinal tract. Candesartan Cilexetil appears in plain tablets or in combination with hydrochlorothiazide (HCTZ).

TAPI has USDMF and EUDMF for Lamotrigine.

Lamotrigine (marketed as Lamictal by GlaxoSmithKline) is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder. For epilepsy it is used to treat partial seizures, primary and secondary tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Lamotrigine also acts as a mood stabilizer. It is the first medication since lithium granted Food and Drug Administration (FDA) approval for the maintenance treatment of bipolar type I.

Rosuvastatin is a synthetic statin-type HMG-CoA reductase inhibitor and is approved for the treatment of various forms of Dyslipidemia:

Elevated LDL cholesterol (Hypercholesterolemia)
• High total cholesterol (Hyperlipidemia)
• Elevated triglycerides (hypertriglyceridemia)

The main advantage of Rosuvastatin compared to other Statins lies with
its high efficacy in lowering LDL cholesterol.   The drug was billed as a super-statin during its clinical development, claimed to offer high potency and improved cholesterol reduction compared to rivals in its class.

The standard for environmental management systems requires:

• Ongoing management commitment to improving environmental aspects of the operation in addition to compliance with legislation and regulation of pollution control.
• Establishment and execution of an environmental policy that includes setting and meeting specific measurable goals.
• Incorporate environmental considerations in production processes.
• Perform tests and ensure ongoing tracking of the environmental management system.

The environmental management system enables the organization to:

• Ensure achievement of its environmental goals
• Present its environmental actions to the community and authorities
• Pursue commercial dealings with countries that require proof of compliance with an environmental policy.  This trend is already apparent in some European countries and U.S. states.