Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd.

USP

20190111-209-J-300

6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone

Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.

29342-05-0

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Shanghai Pharma Group Changzhou Kony Pharmaceutical Co.,Ltd.

USP

20180921-209-J-46

6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridinone

Ciclopirox olamine (used in preparations called Batrafen, Loprox, Mycoster, Penlac and Stieprox) is a synthetic antifungal agent for topical dermatologic treatment of superficial mycoses. In particular, the agent is especially effective in treating Tinea versicolor.

41621-49-2

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Union quimico farmaceutica, S.A

USP

20060302-27-B-229-04(3)

(Z)-N''-cyano-N-methyl-N'-(2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl)guanidine

1-Cyano-2-methyl-3-(2-(((5-methyl-4-imidazolyl)methyl)thio)ethyl)guanidine

2-cyano-1-methyl-3-(2-(((5-methylimidazol-4-yl)methyl)thio)ethyl)guanidine

A histamine congener, it competitively inhibits histamine binding to histamine H2 receptors. Cimetidine has a range of pharmacological actions. It inhibits gastric acid secretion, as well as pepsin and gastrins output. It also blocks the activity of cytochrome P-450 which might explain proposals for use in neoadjuvant therapy.

51481-61-9

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Symbiotica Speciality Ingredients Sdn. Bhd

USP

20170516-93-E-131-08

21-chloro-9-fluoro-11β,17-dihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17-propionate

Clobetasol propionate is a prednisolone derivative with higher specificity for glucocorticoid receptors than mineralocorticoid receptors. It has demonstrated superior activity compared to fluocinonide and was first described in the literature in 1974.

Clobetasol Propionate was granted FDA approval on 27 December 1985.

25122-46-7

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Mylan Laboratories Limitted

In-house

수2816-1ND(2)

4-[bis(2-hydroxyphenyl)-1H-1,2,4-triazol-1-yl]benzoic acid

Deferasirox

Deferasiroxum

Deferasirox is an iron chelator and the first oral medication FDA approved for chronic iron overload in patients receiving long term blood transfusions.

201530-41-8

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Hubei Biocause Heilen Pharmaceutical

Solara Active Pharma Sciences Limited

In-house

20120330-145-I-36-01(5) / 20130208-145-I-184-04(16)

(+)-(S)-p-isobutylhydratropic acid

(2S)-2-(4-isobutylphenyl)propanoic acid

(S)-α-methyl-4-(2-methylpropyl)benzeneacetic acid

d-ibuproten

Dexibuprofen, S(+)-ibuprofen, is a non-steroidal anti-inflammatory drug (NSAID). It is a pharmacologically effective enantiomer of racemic ibuprofen that differs in physicochemical properties. It is proposed to be more pharmacologically active and tolerable with a better safety profile than ibuprofen due to higher concentration of active S enantiomer. Dexibuprofen has a slower dissolution rate in the simulated gastric and enteric juices compared with the racemic ibuprofen and displays improved oral bioavilability. For Metabolism, Enzymes, Carriers, Transporters Sections, refer to Ibuprofen.

51146-56-6

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Hubei Biocause Heilen Pharmaceutical

KP

20120406-145-I-37-02(3)

(2S)-2-[4-(2-methylpropyl)phenyl]propanoic acid

(+)-(S)-p-isobutylhydratropic acid
(2S)-2-(4-isobutylphenyl)propanoic acid
(S)-α-methyl-4-(2-methylpropyl)benzeneacetic acid
d-ibuproten
Dexibuprofeno

Dexibuprofen, S(+)-ibuprofen, is a non-steroidal anti-inflammatory drug (NSAID). It is a pharmacologically effective enantiomer of racemic ibuprofen that differs in physicochemical properties. It is proposed to be more pharmacologically active and tolerable with a better safety profile than ibuprofen due to higher concentration of active S enantiomer. Dexibuprofen has a slower dissolution rate in the simulated gastric and enteric juices compared with the racemic ibuprofen and displays improved oral bioavilability 4. For Metabolism, Enzymes, Carriers, Transporters Sections, refer to Ibuprofen.

51146-56-6

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Mylan Laboratories Limited (Unit-7)

In-house

20171024-209-J-174

2-((R)-((3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl)methyl)sulfinyl)-1H-benzimidazol

Dexlansoprazole is a new generation proton pump inhibitor (PPI) used for the management of symptoms associated with gastroesophageal reflux disease (GERD) and erosive esophagitis. Dexlansoprazole is the R-enantiomer of Lansoprazole, which is composed of a racemic mixture of the R- and S-enantiomers. Compared to the older generation of PPIs (which includes Pantoprazole, Omeprazole, and Lansoprazole), dexlansoprazole MR has a unique pharmacokinetic profile due to its delayed-release and dual-delivery release system. The active ingredient is released in two phases at different pH values and at different time points, resulting in two peak concentrations in the blood; 25% of the dose is released at pH 5.5 in the proximal duodenum, while the remaining 75% is released at pH 6.75 in the distal small intestine. As a result, dexlansoprazole has a peak concentration within 1-2 hours after dosing and another within 4-5 hours. Dexlansoprazole's unique pharmacokinetics addresses limitations of the older generation PPIs including short plasma half-life, break-through symptoms, and need for meal-associated dosing. These characteristics make dexlansoprazole a good option for people who struggle with adherence and strict dosage timing before meals.

138530-94-6

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FSP Galena

EP

수289-5-ND

calcium 2,5-dihydroxybenzenesulfonate

Calcium 2,5-Dihydroxybenzenesulfonate Hydrate

2,5-Dihydroxybenzenesulfonic Acid Calcium Salt Hydrate

Calcium dobesilate is a vasoprotective. It is the calcium salt of dobesilic acid. It is a synthetic molecule with the ability to reduce capillary permeability in the body. In Italy the drug is sold by the pharmaceutical company OM Pharma under the trade name of Doxium in capsules containing 500 mg of active ingredient.

20123-80-2

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Ami Lifesciences Private Limited.

In-house

20181029-209-J-98

Doxophylline

Doxofylline is a methylxanthine derivative with the presence of a dioxolane group in position 7. As a drug used in the treatment of asthma, doxofylline has shown similar efficacy to theophylline but with significantly fewer side effects in animal and human studies. In contrast with other xanthine derivatives, doxofylline does not significantly bind to adenosine alpha-1 or alpha-2 receptors and lacks stimulating effects. Decreased affinity for adenosine receptors may account for the better safety profile of doxofylline compared to theophylline . Unlike theophylline, doxofylline does not affect calcium influx and does not antagonize the actions of calcium channel blockers which could explain reduced cardiac adverse reactions associated with the drug. The anti-asthmatic effects of doxophylline are mediated by other mechanisms, primarily through inhibiting the activities of the phosphodiesterase (PDE) enzyme.

69975-86-6

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Wuhan Wuyao Pharmaceutical Co.,Ltd.

EP

20190404-211-J-331

• (+)-2,2'-(ethylenediimino)di-1-butanol
• (+)-ethambutol
• (+)-N,N'-bis(1-(hydroxymethyl)propyl)ethylenediamine
• (+)-S,S-ethambutol
• (2S,7S)-2,7-diethyl-3,6-diazaoctane-1,8-diol
• (S,S)-ethambutol

An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863)

74-55-5

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Mylan Laboratories Limited

In-house

20190220-209-J-133

5-chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine

5-Chloro-3-(4-methanesulfonyl-phenyl)-6'-methyl-[2,3']bipyridinyl

5-chloro-6'-methyl-3-(p-(methylsulfonyl)phenyl)-2,3'-bipyridine

Etoricoxib is a new COX-2 selective inhibitor. Current therapeutic indications are: treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, chronic low back pain, acute pain and gout. Like any other COX-2 selective inhibitor, Etoricoxib selectively inhibits isoform 2 of cyclo-oxigenase enzyme (COX-2) to reduce the generation of prostaglandins (PGs) from arachidonic acid. It is approved in more than 60 countries worldwide but not in the US.

202409-33-4

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Changzhou Kony Pharmaceutical Co.Ltd.

USP

20180208-209-J-153(2)

2-[(acetyloxy)methyl]-4-(2-amino-9H-purin-9-yl)butyl acetate

2-(2-(2-amino-9H-purin-9-yl)ethyl)-1,3-propanediol diacetate

9-[4-acetoxy-3-(acetoxymethyl)but-1-yl]-2-aminopurine

acetic acid 2-acetoxymethyl-4-(2-amino-purin-9-yl)-butyl ester

Famciclovir, marketed as Famvir by Novartis, is a guanine analogue used to treat herpes virus infections. It is most commonly used to treat herpes zoster (shingles). Famciclovir is a prodrug of penciclovir with higher oral bioavailability.

104227-87-4

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Aurobindo Pharma Limited

EP

20071025-94-E-50-02(10)

(5alpha,17beta)-(1,1-Dimethylethyl)-3-oxo-4-azaandrost-1-ene-17-carboxamide

Finasteride is a synthetic 4-azasteroid compound and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as dutasteride, which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures. In 1998, it was approved by the FDA to treat male pattern hair loss. Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with doxazosin, an alpha-blocker.

Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by in situ high levels of DHT. In the treatment of benign prostate hyperplasia, alpha-blockers such as tamsulosin and terazosin are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.

98319-26-7

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Ipca Laboratories Limited

USP

20050831-74-A-153-07(6)

N/A

Fluconazole, commonly known as Diflucan, is an antifungal drug used for the treatment of both systemic and superficial fungal infections in a variety of tissues. It was initially approved by the FDA in 1990. This drug is an azole antifungal, in the same drug family as ketoconazole and itraconazole. Fluconazole has many advantages over the other antifungal drugs including the option of oral administration. The side effect profile of this drug is minimal. It has been demonstrated as an efficacious treatment for vaginal yeast infections in one single dose

86386-73-4

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