Mylan Laboratories Limited (Unit-11)

EP

20111202-187-I-22-11

N-[2-hydroxy-5-(1-hydroxy-2-{[1-(4-methoxyphenyl)propan-2-yl]amino}ethyl)phenyl]formamide

2'-hydroxy-5'-(1-hydroxy-2-((p-methoxy-α-methylphenethyl)amino)ethyl)formanilide, Formoterol

Formoterol is an inhaled beta2-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers. A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as salbutamol, combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication. It is available as a single-entity product and in several formulations in combination with both inhaled corticosteroids and long-acting muscarinic antagonists.

43229-80-7

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Jiangxi Synergy Pharmaceutical Co., Ltd

USP

20120831-142-I-75-05(6)

2-[1-(aminomethyl)cyclohexyl]acetic acid

1-(Aminomethyl)cyclohexaneacetic acid

Gabapentin is a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) that was first approved for use in the United States in 1993. It was originally developed as a novel anti-epileptic for the treatment of certain types of seizures - today it is also widely used to treat neuropathic pain. Gabapentin has some stark advantages as compared with other anti-epileptics, such as a relatively benign adverse effect profile, wide therapeutic index, and lack of appreciable metabolism making it unlikely to participate in pharmacokinetic drug interactions. It is structurally and functionally related to another GABA derivative, pregabalin.

60142-96-3

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Yantai Dongcheng Biochemicals Co., Ltd.

EP

20100211-124-G-17-01(13)

N/A

N/A

Unfractionated heparin (UH) is a heterogenous preparation of anionic, sulfated glycosaminoglycan polymers with weights ranging from 3000 to 30,000 Da. It is a naturally occurring anticoagulant released from mast cells. It binds reversibly to antithrombin III (ATIII) and greatly accelerates the rate at which ATIII inactivates coagulation enzymes thrombin (factor IIa) and factor Xa. UH is different from low molecular weight heparin (LMWH) in the following ways: the average molecular weight of LMWH is about 4.5 kDa whereas it is 15 kDa for UH; UH requires continuous infusions; activated partial prothrombin time (aPTT) monitoring is required when using UH; and UH has a higher risk of bleeding and higher risk of osteoporosis in long term use. Unfractionated heparin is more specific than LMWH for thrombin. Furthermore, the effects of UH can typically be reversed by using protamine sulfate.

9005-49-6

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Chongqing Huapont Shengchem Pharmaceutical Co., Ltd.

USP

20171226-209-J-4

(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid

(7E,9E,11E,13Z)-retinoic acid

13-cis-retinoic acid

13-cis-Vitamin A acid

13-RA

cis-RA

Isotretinoin is a retinoid derivative of vitamin A used in the treatment of severe recalcitrant acne.It was most widely marketed under the brand name Accutane, which has since been discontinued.Isotretinoin is associated with major risks in pregnancy and so it is only available under the iPLEDGE program in the United States. The first isotretinoin containing product was FDA approved on 7 May 1982.

4759-48-2

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Zhejiang East-Asia Phamaceutical Co.,Ltd

USP

20190111-167-I-565-06

1-[4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]ethan-1-one

N/A 

Ketoconazole is an imidazole antifungal agent used in the prevention and treatment of a variety of fungal infections.^Label It functions by preventing the synthesis of ergosterol, the fungal equivalent of cholesterol, thereby increasing membrane fluidity and preventing growth of the fungus.^5,11 Ketoconazole was first approved in an oral formulation for systemic use by the FDA in 1981.⁹ At this time it was considered a significant improvement over previous antifungals, miconazole and clotrimazole, due to its broad spectrum and good absorption. However, it was discovered that ketoconazole produces frequent gastrointestinal side effects and dose-related hepatitis.^9,10 These effects combined with waning efficacy led to its eventual replacement by triazole agents, fluconazole, itraconazole, [voraconazole], and posaconazole. Ketoconazole and its predecessor clotrimazole continue to be used in topical formulations.

65277-42-1

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Saurav Chemicals Limited

USP

20170926-61-C-362-12

5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid

rac-Ketorolac

Ketorolac is a Non-steroidal anti-inflammatory drug (NSAID) and is commercially available as an oral tablet, injectable, nasal spray and as an ophthalmic solution. It's analgesic properties make it a useful pain management tool across many settings including postoperative pain, rheumatoid arthritis, osteoarthritis, menstrual disorders, headaches, spinal and soft tissue pain, and ankylosing spondylitis. Impressively, ketorolac has a similar efficacy to standard doses of morphine and meperidine making it a useful opioid sparing agent.

74103-07-4

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Sun Pharmacetical Industries Ltd.

In-house

20101130-128-H-34-05(3)

3-{1-[(3,3-diphenylpropyl)(methyl)amino]-2-methylpropan-2-yl} 5-methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate

N/A

Lercanidipine is a calcium channel blocker of the dihydropyridine class. It is sold under various commercial names including Zanidip.

100427-26-7

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Aurobindo Pharma Limited (Unit-XI)

USP

20120302-183-I-34-01(1)

(2S)-2-(2-oxopyrrolidin-1-yl)butanamide

N/A

Levetiracetam is a drug within the pyrrolidine class that is used to treat various types of seizures stemming from epileptic disorders. It was first approved for use in the United States in 1999 and is structurally and mechanistically unrelated to other anti-epileptic drugs (AEDs). Levetiracetam possesses a wide therapeutic index and little-to-no potential to produce, or be subject to, pharmacokinetic interactions - these characteristics make it a desirable choice over other AEDs, a class of drugs notorious for having generally narrow therapeutic indexes and a propensity for involvement in drug interactions.

102767-28-2

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RA Chem Pharma Limitied

USP

20110429-40-C-279-18

2-(2-{4-[(R)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid

2-(2-{4-[(R)-(4-chlorophenyl)(phenyl)methyl]piperazin-1-yl}ethoxy)acetic acid

Levocetirizine is a selective histamine H1 antagonist used to treat a variety of allergic symptoms. It is the R enantiomer of cetirizine. Levocetirizine has greater affinity for the histamine H1 receptor than cetirizine.

Levocetirizine was granted FDA approval in 1995.

130018-87-C

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Zhejiang East-asia Pharmaceutical Co., Ltd.

USP

20100414-102-F-50-10(10)

(2S)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0⁵,¹³]trideca-5(13),6,8,11-tetraene-11-carboxylic acid

(-)-Ofloxacin

(3S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid

(S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzooxazine-6-carboxylic acid

(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid

(S)-Ofloxacin

L-Ofloxacin

Levofloxacin

Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic ofloxacin. It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer).Levofloxacin, along with other quinolones such as gatifloxacin and moxifloxacin, is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections.

Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.

100986-85-4

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Zhejiang East-Asia Pharmaceutical Co., Ltd.

USP

20100414-102-F-50-10(10)

bis((2S)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0⁵,¹³]trideca-5(13),6,8,11-tetraene-11-carboxylic acid) hydrate

L-ofloxacin / Levofloxacin / Levofloxacin (as hemihydrate) / Levofloxacin hydrate / Ofloxacin S-(-)-form hemihydrate

Levofloxacin is a fluoroquinolone antibiotic and the optical S-(-) isomer of racemic ofloxacin. It reportedly carries 8 to 128-fold more activity against both gram-negative and gram-positive bacteria compared to R-(+)-ofloxacin¹ and remains stereochemically stable following administration (i.e. it does not invert to the inactive isomer). Levofloxacin, along with other quinolones such as gatifloxacin and moxifloxacin, is a member of the third generation of fluoroquinolones, colloquially referred to as the "respiratory quinolones" due to improved activity against gram-positive bacteria commonly implicated in respiratory infections.

Levofloxacin was first approved by the FDA in 1996, and was approved in Canada and several South American countries soon after.¹

1381997-71-0

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Jiangsu Tasly DiYi Pharmaceutical Co., Ltd

KP

20190226-5-B-415-12

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IPCA Laboratories Limited / Zhejiang Huahai Pharmacetical Co., Ltd / Zhejiang Tianyu Pharmaceutical Co., Ltd

USP

20100226-122-G-47-16(2) / 20100226-122-G-72-17(7) / 20100616-122-G-60-22(12)

potassium 5-[2-(4-{[2-butyl-4-chloro-5-(hydroxymethyl)-1H-imidazol-1-yl]methyl}phenyl)phenyl]-1,2,3,4-tetrazol-2-uide

N/A

Losartan is an angiotensin II receptor blocker (ARB) used to treat hypertension. Angiotensin-converting enzyme (ACE) inhibitors are used for a similar indication but are associated with a cough. When patients with ACE inhibitor associated coughs are switched to ARBs like losartan, they have an incidence of cough similar to placebo or hydrochlorothiazide. Losartan is available as losartan potassium oral tablets as well as a combination tablet of losartan potassium and hydrochlorothiazide. Patients taking losartan should have their renal function and potassium levels monitored. Losartan was granted FDA approval on 14 April 1995.

124750-99-8

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Tianjin Tianyao Pharmaceuticals Co., Ltd

EP/USP

20180706-209-J-239

(1R,3aS,3bS,5S,9aR,9bS,10S,11aS)-1,10-dihydroxy-1-(2-hydroxyacetyl)-5,9a,11a-trimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one

(6α,11β)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione

1-dehydro-6α-methylhydrocortisone

6α-methyl-11β,17α,21-triol-1,4-pregnadiene-3,20-dione

delta(1)-6alpha-Methylhydrocortisone

Methylprednisolone is a prednisolone derivative glucocorticoid with higher potency than prednisone.9 It was first described in the literature in the late 1950s.

Methylprednisolone was granted FDA approval on 24 October 1957.

83-43-2

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Wuhan Wuyao Pharmaceutical Co., Ltd

EP

20160114-104-F-83-03(6)

2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethan-1-ol

1-(2-hydroxy-1-ethyl)-2-methyl-5-nitroimidazole

1-(2-hydroxyethyl)-2-methyl-5-nitroimidazole

1-(β-ethylol)-2-methyl-5-nitro-3-azapyrrole

1-(β-hydroxyethyl)-2-methyl-5-nitroimidazole

1-(β-oxyethyl)-2-methyl-5-nitroimidazole

2-methyl-1-(2-hydroxyethyl)-5-nitroimidazole

2-methyl-3-(2-hydroxyethyl)-4-nitroimidazole

2-methyl-5-nitroimidazole-1-ethanol

Metronidazole is a commonly used antibiotic, belonging to the nitroimidazole class of antibiotics. It is frequently used to treat gastrointestinal infections as well as trichomoniasis and giardiasis, and amebiasis which are parasitic infections. Metronidazole has been used as an antibiotic for several decades, with added antiparasitic properties that set it apart from many other antibacterial drugs, allowing it to treat a wide variety of infections. It is available in capsule form, tablet form, and topical form, and suppository preparations for the treatment of various infections.

443-48-1

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