API - Regulatory Market



Products

Category

CAS No.

Approvals

Abiraterone acetate

Prostatic cancer

154229-18-2

USDMF No.: 26779,FDA approved

Adefovirpivoxil

Antivirals

142340-99-6

GMP

Alogliptin Benzoate

Anti-Diabetic

850649-62-6

USDMF 27993

Amlodipine Besylate

Ion channel modulators

111470-99-6

USDMF 21951, FDA approved.

Aripiprazole

Schizophrenia

129722-12-9

GMP

Azilsartan Kamedoxomil

Hypertension

863031-24-7

USDMF 29818

Azithromycin Bitterless

Antibiotic

83905-01-05

Technical Package available

Bacitracin, injectable.

Antibiotics

1405-87-4

USDMF 23999, GMP, FDA approved

Bisoprololfumarate

Hypertension

104344-23-2

EP,CP

Bivalirudin

Antithrombotics

128270-60-0

USDMF 24257, FDA approved

Bortezomib

Cancer

179324-69-7

DMF to be filed

Brinzolamide

Ophthalmic

138890-62-7

USDMF 23789, Canadian DMF,ASMF, FDA will inspect( From ALP), EDMF Available (From Duke Chem),

Bromfenac Sodium

Anti-inflammatory

120638-55-3

USDMF 23031 FDA Approved, Canada DMF,2010-198,ASMF, Japan DMF, EDMF

Canagliflozin

Diabetes

842133-18-0

USDMF No.: 30853

Calcipotriene anhydrous

Vitamin

112965-21-6

USDMF 21943

Calcipotriene monohydrate

Vitamin

147657-22-5

USDMF 27222

Carfilzomib

Cancer

868540-17-4

USDMF No.: 030162

Cetrorelix Acetate

Gonadotropins and GnRH

120287-85-6

USDMF No.:029849,FDA approved

CidofovirDihydrate

Antiviral

149394-66-1

USDMF 23446, DMF reviewed, FDA Approved, Canada DMF, 2012-031, ASMF. DMF fee paid.

Cilostazol

Antithrombotics

73963-72-1

USDMF 25666,FDA Approved, Canada DMF,GMP

Cinchocaine/Dibucaine Hydrochloride

A local anesthetic

61-12-1

EP

Clindamycin hydrochloride

Antibotics

21462-39-5

USP, EP,CP

Clindamycin palmitate hydrochloride

Antibiotics

25507-04-4

USP, EP,CP

Clindamycin phosphate

Antibiotics

24729-96-2

USP,EP

Cloxacillin sodium

Antibiotics

7081-44-9

GMP

DabigatranEtexilate

Anticoagulant

211915-06-9

China Registration filed

Dapagliflozin Propanediol

Anti-Diabetic

960404-48-2.

USDMF 27838

Dasatinib

Chemotherapeutic Agents

302962-49-8

USDMF No.:29505

Diacerein

Anti-Arthritic

13739-02-1

EDMF Available

Dibucaine/Cinchocaine Base

A local anesthetic

85-79-0

USP

Dorzolamide HCl

Anti-Glaucoma

130693-82-2

USP/EP grade, EDMF Available

Doxapram Hydrochloride

Respiratory stimulant

113-07-5

29848

Doxercalciferol

Vitamin

54573-75-0

USDMF 25148,Canadian DMF,ASMF

Dronedarone Hydrochloride

Antiarrhythmic agent

141625-93-6

USDMF 28200. FDA approved

Duloxetine HCl

Anti-Depressant

144060-53-7

Under Development

Dutasteride

BPH

164656-23-9

China Registration filed

Eptifibatide

Antithrombotics

188627-80-7

USDMF 23786,DMF reviewed, FDA approved, Canadian DMF,ASMF

Empagliflozin

Anti-diabetic

864070-44-0

29796

Enoxaparin sodium

Antithrombotics

9005-49-6

GMP

Etofenamate

Anti-Inflammatory

30544-47-9

EDMF & CEP Available

Febuxostat

For treatment of gout and hyperuricemia.

144060-53-7

USDMF 25664, ASMF, FDA will inspect ( From ALP),

Ferric carboxymaltose

Anaemia

9007-72-1

DMF to be filed

Furbenicillin sodium

Antibiotics

GMP

Goserelin Acetate

Gonadotropins and GnRH

65807-02-5

029713, FDA approved

Imepenem + Cilastin (Sterile)

Antibacterial

GMP

Imipenem( Sterile)

Antibacterial

USDMF: 31777

Iron sucrose

Anaemia

8047-67-4

USDMF No.: 18390

Ivabradine Hydrochloride

Cardiovascular Agent

148849-67-6

USDMF No.: 28658

Lanreotide Acetate

Peptidergics

74381-53-6

USDMF 24378 FDA Approved facility, Canadian DMF, ASMF

LapatinibDitosylate

Chemotherapeutic Agent

388082-78-8

29712

Latanoprost

Anti-Glacucoma

130209-82-4

EDMF

Liraglutide

Anti-Diabetic

204656-20-2

FDA approved on Sep.24, 2014.

Lornoxicam

NSAIDS

70374-39-9

CP

LoteprednolEtabonate

Glucocorticoids and Antiglucocorticoids

82034-46-6

USDMF 22278, FDA Approved facility, Canadian DMF, ASMF

Lurasidone Hydrochloride

Antipsychotics

367514-88-3

USDMF 27584, FDA twice Approved facility

Mesalamine

Anti-Diarrheal

89-57-6

024256, CEP approved. Canadian DMF 2015-141

Methylnaltrexone bromide

Opioid induced Constipation

73232-52-7

DMF in preparation

Mezlocillin sodium

Antibiotics

59798-30-0

GMP

Nepafenac

Non-steroidal anti-inflammatory drugs

78281-72-8

USDMF 23032, FDA Approved facility, Canada DMF 2012-035

Nimodipine

Vasodilator Cerebral

66085-59-4

EDMF Available

Nitazoxanide

Antihelmintic

55981-09-4

EDMF Available

Oxacillin sodium

Antibacterials

66-79-5

GMP

Palonosetron Hydrochloride

Antiemetics

135729-62-3

USDMF, 23209, FDA Approved. Canada DMF 2012-032,GMP

Paricalcitol

Vitamin

131918-61-1

USDMF 21255,Canadian DMF,ASMF

Pemetrexed Disodium

Cancer

150399-23-8

USDMF No.: 22141,USFDA audited

Pidotimod

Immunositmulant

121808-62-6

CP

PirisudanolDimaleate

Anti- Depressant

53659-00-0

EDMF Available

Roflumilast

For chronic obstructive pulmonary disease

162401-32-3

USDMF 27779

Saxagliptin Hydrochloride

Anti-Diabetic

709031-78-7

USDMF No.:29299

Silodosin

Prostatic Hyperplasia

158930-17-7

USDMF : 027082

Sitagliptin Phosphate Monohydrate

Anti-Diabetic

654671-77-9

USDMF No.:28325

Sodium Bicarbonate( Sterile)

144-55-8

GMP

Sofosbuvir

Anti- Viral

1190307-88-0

USDMF No.:28919

Sulbenicillin sodium

Antibiotics

28002-18-8

GMP

Tamsulosin Hydrochloride

Drugs used in benign prostatic hyperplasia

106463-17-6

DMF2013-014, 21951, FDA inspected in July 2015 and approved.

Tranexamic Acid

Antihemorrhagics

1197-18-8

USDMF 22277, FDA Approved, DMF reviewed, Canada DMF2009-178, GMP, EDQM approved.

Tropicamide

Mydriasis-eye drops

1508-75-4

EP

Vildagliptin

Anti-Diabetic

274901-16-5

USDMF No.:28133

Vecuronium bromide

Muscle Relaxants

50700-72-6

GMP

Vortioxetine Hydrochloride

Anti-depressant

USDMF No.: 029849

ZoledronicAcid,monohydrate

Drugs for treatment of bone diseases

165800-06-6

USDMF 23847, GMP, ASMF, US FDA inspected on Aug 19 to 23, 2013 only 2 483s and approved on Sep.12, 2014.

APIs Under Development

Products

Category

CAS No.

Approvals

Alprostadil

Vasodilator

745-65-3

Pipeline product

AripiprazoleLauroxil

Schizophrenia

1259305-29-7

Lab scale

Apremilast

Psoriasis

608141-41-9

Pilot Batch

Bimatoprost

Anti-Glacucoma

155206-00-1

Development Stage

CarboprostTrometamol

Prostanoid signaling modulators

58551-69-2

Development Stage

Doripenem

Antibiotic

148016-81-3

Lab R&D

Dinoprost

Prostanoid signaling modulators

38562-01-5

Development Stage

Duloxetine HCl

Antidepressants

116539-59-4

Development Stage

Ertapenem

Antibiotic

153832-46-3

Lab R&D

Ferric Citrate

Hyperphosphatemia

2338-05-8

Pilot batch

Ferric Maltol

Anaemia

33725-54-1

Lab Scale

Ferric Pyrophosphate

Anaemia

10058-44-3

Lab Scale

Ferumoxytol

Anaemia

722492-56-0

Lab Scale

Fingolimod

Multiple Sclerosis

162359-55-9

Development Stage

Frovatriptan Succinate Monohydrate

Anti- Migraine

158930-17-7

Development Stage

Misoprostol

AINS

59122-46-2

Pipeline product

Prasugrel

Cardiovascular Thrombosis

150322-43-3

Under Development

Travoprost

Antiglaucoma

130209-82-4

Development Stage

Treprostinil

Vasodilator

81846-19-7

Pipeline product



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