Sunday, June 21, 2009

China Affrect on india chemical API Actice pharmaceuticas intermediates, manufacturer,API provider,API, API Manufacturer

alThough Indian API manufacturers are often recognized for being ahead of the game in terms of meeting Western quality standards, Chinese producers are closing the gap. The privatization of state-run enterprises is shifting the focus away from volume sales and competition on price alone, and toward partnerships and profit.

“In this past year, there has been a tremendous amount of change in China,” says Sue Capie, director, PharmaVantage. Ms. Capie was speaking at the Generic Pharmaceutical Association 2005 API conference held recently in New York.

One major change that took place in 2004 was the reorganization of the Chinese regulatory authorities that monitor the drug industry. In 2003, the State Drug Administration created a new channel, the State Food and Drug Administration (SFDA), modeled on the US system and dedicated to overseeing food, chemicals and cosmetics.

Further, 2004 marked the deadline for Chi-nese compliance with international guidelines implemented in 1999 for factories to achieve compliance with Chinese good manufacturing practices.

The recent changes are the latest stage in a major revolution over the past decade in the way Chinese manufacturing operates. In the past, the country was operating under the “planned economy,” which meant the government dictated what factories produced and where their products were sold. The government subsidized operations, and export was allowed only through trade companies.

But subsidies have been reduced or withdrawn as the planned economy shifts to a market economy, leaving manufacturers responsible for portfolio management, production decisions and for exporting their goods.

The resulting competitive environment has led to waves of consolidation throughout the Chinese pharmaceutical industry. One cycle of M&A involved API manufacturers acquiring finished dosage companies and chain stores, and another cycle involved chain stores back-integrating into finished dosage forms.

However, “the biggest impact [of the shift] has been a psychological impact,” says Capie. “Before, there was really no incentive” for factories to turn a profit and stay competitive.

“The increasing domestic competition has meant that companies across the board, particularly for larger factories, are investing money in R&D to broaden their portfolio,” says Capie. “And the factories that have survived these changes are bound and determined that they’re going to compete in the global arena. They have money to spend and are looking to do so with partners abroad.”

However, there are still quite a few hurdles for Chinese companies to overcome before they can become a force in the global API market. “Despite all the excitement with what’s happening in China, you still need to be realistic and think about existing problems that will continue on in the next decade,” says Capie.

Language continues to be a barrier, and though Chinese companies are becoming better informed about intellectual property issues and expectations, “the major problem is, no one in China has a legal staff devoted to patent searches,” Capie notes.

While the overhaul of management at companies may produce young talent that can revitalize companies, shifts in management can also create confusion and difficulty in communicating with a partner.

Chinese companies still may be prone to bite off more than they can chew in terms of projects, and have yet to have a good management system for R&D efforts. “It is still typical for the Chinese to have multiple new projects going on—you often see many projects dangling,” says Capie.

There are also other issues that may become magnified as China becomes more of a manufacturing force. For example, many companies still have ground to cover in order to make manufacturing environmentally sound.

Despite the hurdles, the interest in sourcing APIs from China will only increase as pharma companies try to find ways to lower costs and increase efficiency.


Fine Chemicals
Denatonium Benzoate

Anthranilic acid, its esters, and its salts

Benzyl cyanide

Ephedrine, its salts, optical isomers, and salts of optical isomers

Ergonovine and its salts

Ergotamine and its salts

Hydroiodic acid

Norpseudoephedrine, its salts, optical isomers, and salts of optical isomers

Phenyl acetic acid, its esters, and its salts

Phenylpropanolamine, its salts, optical isomers, and salts of optical isomers

Phosphorus (white or red allotropes)

Piperidine and its salts

Pseudoephedrine, its salts, optical isomers, and salts of optical isomers

3,4-methylenedioxyphenyl-2-propanone

Benzaldehyde

Nitroethane

Gamma butyrolactone

N-Phenethyl-4-piperidinone

Methylamine

Ethylamine

Propionic anhydride

Isosafrole

Safrole

Piperonal

N-methylephedrine

N-methylpseudoephedrine

Acetic anhydride

Acetone

Benzyl chloride

Diethyl ether

Potassium permanganate

2-butanone (or methyl ethyl ketone)

Toluene

Hydrochloric acid (including anhydrous hydrogen chloride)

Methyl isobutyl ketone


Product

Therapeutic Category

Specifications

CAS No.

Acamprosate Calcium

Alcoholism Treatment

BP / EP

[77337-73-6]

Alendronate Sodium [#]

Antiosteoporosis

EP

[121268-17-5]

Amitriptyline [$]

Antidepressant

USP

[50-48-6]

Anastrozole

Antineoplastic

PN

[120511-73-1]

Atomoxetine Hcl

Antidepressant

PN

[82248-59-7]

Balsalazide

Antiinflammatory

PN

[82101-18-6]

Bicalutamide

NSAID

USP

[90357-06-5]

Budesonide

Antiinflammatory Steroid

BP / EP

[51333-22-3]

Bupropion Hcl

Antidepressant

BP / EP / USP

[31677-93-7]

Calcitonin

Antiosteoporosis

BP

[47931-85-1]

Capecitabine

Antineoplastic

PN

[154361-50-9]

Carbamazepine

Antiepileptic

BP

[298-46-4]

Carboplatin [$,*]

Anticancer

BP / EP / USP

[41575-94-4]

Carisoprodol [$]

Muscle Relaxant

USP

[78-44-4]

Carvedilol [$,*]

Antihypertensive

BP / EP

[72956-09-3]

Cefuroxime Axetil [*]

3rd Generation Cephalosporin

EP

[64544-07-6]

Cisplatin [*]

Anticancer

EP / USP

[15663-27-1]

Citalopram Hbr. [$]

Antidepressant

USP

[59729-32-7]

Clomipramine Hcl [*]

Antidepressant

BP / EP

[17321-77-6]

Clonazepam [$]

Antiepileptic

EP / USP

[1622-61-3]

Clopidogrel Bisulfate

Antithrombotic

USP

[135046-48-9]

Danazol

Androgen Derivative

USP

[17230-88-5]

Desloratadine [$]

Antihistaminic

PN

[100643-71-8]

Desmopressin Monoacetate

Vasopressin Analogue

EP

[62288-83-9]

Divalproex Sodium

Antiepileptic

PN

[76584-70-8]

Dobutamine Hcl

Cardiovascular

EP / USP

[49745-95-1]

Donepezil [$]

Antialzheimer

PN

[120014-06-4]

Dothiepin Hcl [*]

Antidepressant

BP / EP

[897-15-4]

Entacapone

Antiparkinsons

PN

[130929-57-6]

Eptifibatide

Antithrombotic

PN

[188627-80-7]

Escitalopram HBr

Antidepressant

PN

[128196-01-0]

Eszopiclone

Hypnotic

PN

[138729-47-2]

Finasteride

Antialopecia Agent

PN

[98319-26-7]

Flurbiprofen [*]

NSAID

BP / EP / JP

[5104-49-4]

Fluticasone Propionate [$,*]

Antiallergic

BP / EP

[80474-14-2]

Fluvoxamine Maleate [$]

Antidepressant

BP / EP

[61718-82-9]

Fosphenytoin Sodium [$]

Antiepileptic

USP

[92134-98-0


Product

Therapeutic Category

Specifications

CAS No.

Gabapentin [$, #]

Antiepileptic

USP

[60142-96-3]

Gemcitabine Hcl [$,#]

Anticancer

EP / USP

[122111-03-9]

Glimepiride [$]

Antidiabetic

EP / USP

[93479-97-1]

Granisetron Hcl [$]

Antiemetic

EP

[107007-99-8]

Ibandronate Sodium

Bone Resorption Inhibitor

PN

[138926-19-9]

Imatinib Mesylate [$]

Anticancer

PN

[220127-57-1]

Irbesartan

Antihypertensive

PN

[138402-11-6]

Irinotecan Hcl

Anticancer

PN

[100286-90-6]

Isradipine [$]

Antihypertensive

USP

[75695-93-1]

Lamotrigine [$]

Antiepileptic

PN

[84057-84-1]

Lercanidipine Hcl

Antihypertensive

PN

[132866-11-6]

Letrozole

Anticancer

EP

[112809-51-5]

Losartan Potassium [#]

Antihypertensive

USP

[124750-99-8]

Loteprednol Etabonate

Antiinflammatory

PN

[82034-46-6]

Magnesium Valproate

Antiepileptic

PN

[62959-43-7]

Meloxicam [#]

Antiinflammatory

BP / EP

[71125-38-7]

Memantine Hcl

Antiparkinsons

PN

[41100-52-1]

Mesalazine [$,*]

Antiinflammatory

EP / USP

[89-57-6]

Metamizol Magnesium

Antispasmodic

PN

[6150-97-6]

Metaxalone

Muscle Relaxant

PN

[1665-48-1]

Metformin Hcl [$,*]

Antidiabetic

BP / EP / USP

[1115-70-4]

Metoprolol Tartrate [$,*]

Cardiovascular

BP / EP / USP

[56392-17-7]

Mifepristone

Abortifacient

PN

[84371-65-3]

Mirtazapine [$]

Antidepressant

USP

[61337-67-5]

Modafinil [$]

CNS Stimulant

USP

[68693-11-8]

Mometasone Furoate

Antiinflammatory Steroid

USP

[83919-23-7]

Naltrexone Hcl

Narcotic Antagonist

USP

[16676-29-2]

Netaglinide

Product

Therapeutic Category

Specifications

CAS No.

Octreotide Acetate [$,#]

Somatostatin Analologue

PN

[79517-01-4]

Olanzapine

Antipsychotic

PN

[132539-06-1]

Ondansetron Base [$]

Antiemetic

EP / USP

[116002-70-1]

Ondansetron Hcl [$,*]

Antiemetic

EP / USP

[103639-04-9]

Oxaliplatin [$]

Anticancer

EP

[61825-94-3]

Oxcarbazepine [$]

Antiepileptic

PN

[28721-07-5]

Oxethazaine

Local Anaesthetic

BP / EP

[126-27-2]

Pamidronate Disodium [$,#]

Antiosteoporosis

BP

[109552-15-0]

Pentoxifylline [$,*]

Peripheral Vasodialotor

BP / EP / USP

[6493-05-6]

Perindopril

Calcium Channel Blocker

BP / EP

[107133-36-8]

Pioglitazone

Antidiabetic

PN

[105355-27-9]

Piroxicam Betacyclodextrine

Antiinflammatory

PN

[96684-40-1]

Raloxifene Hcl

Antiosteoporosis

PN

[82640-04-8]

Repaglinide [$]

Antidiabetic

USP

[135062-02-1]

Rivastigmine Tartrate [$]

Acetylcholinesterase inhibitors,
Cognition-enhancing drugs

PN

[129101-54-8]

Ropinirole

Antiparkinsons

PN

[91374-21-9]

Sertraline Hcl [$]

Antidepressant

PN

[79559-97-0]

Sodium Valproate [$,*]

Antiepileptic

BP / EP / USP

[1069-66-5]

Sumatriptan Succinate [$]

Antimigraine

BP / EP

[103628-48-4]

Temozolomide

Anticancer

PN

[85622-93-1]

Terlipressin

Vasopressor Analogue

PN

[14636-12-5]

Testosterone

Androgen Derivative

USP

[58-22-0]

Tiagabine Hcl [$]

Antiepileptic

USP

[145821-59-6]

Tizanidine Hcl [$]

Muscle Relaxant

USP

[64461-82-1]

Topiramate [$,#]

Antiepileptic

USP

[97240-79-4]

Tramadol Hcl [$,*]

Analgesic

EP

[22204-88-2]

Valproic Acid

Antiepileptic

BP / EP / USP

[99-66-1]

Venlafaxine Hcl

Antidepressant

EP

[99300-78-4]

Ziprasidone Hcl

Antipsychotic

PN

[138982-67-9]

Zoledronic Acid

Bone Resorption Inhibitor

PN

[165800-06-6]

Zolpidem Tartrate [$,*]

Product

Therapeutic Category

Specifications

CAS No.

Acenocoumarol

Anticoagulant

Ph.Hg.

[152-72-7]

Aluminium-magnesium-hydroxy-carbonate-hexahydrate

Antacid

PN

[21645-51-2]

Buprenorphine HCl

Analgesic

EP

[53152-21-9]

Codeine base

Analgesic,Antitussive

BP / EP / USP

[76-57-3]

Codeine phosphate hemihydrate [*]

Analgesic,Antitussive

BP / EP / USP

[41444-62-6]

Dihydrocodeine hydrogentartrate

Analgesic,Antitussive

BP / EP

[5965-13-9]

Ethylmorphine HCl

Analgesic,Antitussive

BP / EP

[125-30-4]

Glibornuride [#]

Antidiabetic

PN

[26944-48-9]

Hydroxychloroquine sulphate [$]

Antimalarias,Antirheumatic

BP / USP

[747-36-4]

Morphine HCl

Analgesic

BP / EP

[52-26-6]

Morphine sulphate

Narcotic analgesic

BP / EP / USP

[64-31-3]

Noroxymorphone

Intermediate

PN

[33522-95-1]

Noscapine base

Antitussive

BP / EP / USP

[128-62-1]

Oxycodone

Intermediate

PN

[76-42-6]

Oxymorphone

Intermediate

PN

[76-41-5]

Phenobarbital acid [$, #]

Antiepileptic

BP / EP / USP

[50-06-6]

Phenobarbital sodium

Antiepileptic

BP / EP

[57-30-7]

Thebaine

Pharmaceuticals API List

Alfuzosin

Amlodipine Besylate

Aripiprazole

Atorvastatin Calcium

Candesartan Cilaxetil

Cetirizine Dihydrochloride

Ciprofloxacin HCl

Dextromethorphan Base

Diltiazem HCl

Domperidone Base

Domperidone Maleate

Doxazosin Mesylate

Duloxetine HCl

Dutasteride

Enalapril Maleate

Esomeprazole Magnesium

Famotidine

Fexofenadine HCl

Fluconazole

Fluoxetine HCl

Galantamine HBr

Ibuprofen

Lacidipine

Lamotrigine

Lansoprazole

Levetiracetam

Levo Cetirizine

Levofloxacin

Loratadine

Losartan Potassium

Metoprolol Succinate

Montelukast Sodium

Moxifloxacin HCl

Naproxen

Naratriptan

Norfloxacin

Nizatidine

Olmesartan

Omeprazole

Omeprazole Sodium

Oxaprozin

Paroxetine

Pantoprazole

Primidone

Quetiapine Fumarate

Quinine Sulfate

Rabeprazole Sodium
Ramipril
Ranitidine Hydrochloride

Rivastigmine Tartrate

Rizatriptan

Rosiglitazone Maleate

Telmisartan

Tamsulosin HCl

Tegaserod Maleate

Terbinafine HCl

Tolterodine Tartrate

Trandolapril

Valdecoxib

Valsartan

Venlafaxine

Voriconazole

Zolmitriptan

Zonisamide

Non Cephalosporins
Betalactams Piperacillin
EP/USP/JP
Tazobactam
USP
Meropenem
USP
First Generation
Cefalexin
EP/BP/USP/CP/JP
Cefradine
EP/BP/USP
Cefadroxil
EP/BP/USP
Second Generation
Cefprozil
USP
Third Generation
Cefixime
EP/BP/USP
Cefdinir
JP
Ceftibuten
In-House
Cefditoren Pivoxil
JP
Sterile Cephalosporins
First Generation
Cefazolin Sodium
EP/BP/USP
Second Generation
Cefuroxime Sodium
EP/BP/USP
Cefoxitin Sodium
EP/BP/USP
Cefotetan Sodium
USP
Third Generation
Cefotaxime Sodium
EP/BP/USP
Cefoperazone Sodium
EP/CP
Ceftizoxime Sodium
USP
BP - British Pharmacopoeia CP - Chinese Pharmacopoeia EP - European Pharmacopoeia JP - Japanese Pharmacopoeia USP - United States Pharmacopoeia
***
Product exploitation, including development, sales and offer for sale are performed where permissible by patent law. This presentation is not and should not constitute as an offer for sale in territories where it is not permitted by law.


Intermediate PN

[115-37-7]

Hypnotic

BP / EP

[99294-93-6]

Antidiabetic

PN

[105816-04-4]






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Taj Pharmaceuticals Chemical List

Fine Chemicals






Denatonium Benzoate







Anthranilic acid, its esters, and its salts








Benzyl cyanide






Ephedrine, its salts, optical isomers, and salts
of optical isomers





Ergonovine and its salts






Ergotamine and its salts






Hydroiodic acid








Norpseudoephedrine, its salts, optical isomers,
and salts of optical isomers





Phenyl acetic acid, its esters, and its salts






Phenylpropanolamine, its salts, optical isomers,
and salts of optical isomers






Phosphorus (white or red allotropes)





Piperidine and its salts






Pseudoephedrine, its salts, optical isomers, and
salts of optical isomers






3,4-methylenedioxyphenyl-2-propanone





Benzaldehyde






Nitroethane






Gamma butyrolactone





N-Phenethyl-4-piperidinone






Methylamine






Ethylamine





Propionic anhydride






Isosafrole






Safrole





Piperonal






N-methylephedrine






N-methylpseudoephedrine





Acetic anhydride






Acetone






Benzyl chloride





Diethyl ether






Potassium permanganate






2-butanone (or methyl ethyl ketone)





Toluene






Hydrochloric acid (including anhydrous hydrogen
chloride)






Methyl isobutyl ketone










Note: These chemicals are designated as those that are
used in the manufacture of the controlled substances and are important
to the manufacture of the substances. For any (Control Substance)
products Import and Export *** subjected to your country government laws
/control substance ACT.













Note /Government
Notification: These chemicals are designated as those that are
used in the manufacture of the controlled substances and are
important to the manufacture of the substances. For any (Control
Substance) products Import and Export *** subjected to your
country government laws /control substance ACT.

Information:  The information on this web page is provided to
help you to work safely, but it is intended to be an overview of
hazards, not a replacement for a full Material Safety Data Sheet
(MSDS). MSDS forms can be downloaded from the web sites of many
chemical suppliers. ,also that the information on the PTCL
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Benzoate.htm/" the page is maintained by the Safety Officer in
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copy made by some other person and we have no responsibility for
it.

The Controlled Substances Act (CSA) was enacted into law by the
Congress of the United States as Title II of the Comprehensive
Drug Abuse Prevention and Control Act of 1970.[1] The CSA is the
federal U.S. drug policy under which the manufacture,
importation, possession, use and distribution of certain
substances is regulated. The Act also served as the national
implementing legislation for the Single Convention on Narcotic
Drugs


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