Delivering High Quality Affordable APIs To The World Market

APIs

(UNIT 1)

US DMF USFDA

CEP / ASMF EDQM

TGA Australia

WHO-GMP India

US DMF USFDA

CEP / ASMF EDQM

TGA Australia

COFEPRIS Mexico

KOREAN FDA

SFDA China*

WHO-GMP India

*Application Filed

US DMF USFDA

CEP / ASMF EDQM

TGA Australia

COFEPRIS Mexico

KOREAN FDA

SFDA China

WHO-GMP India

US DMF USFDA

CEP / ASMF EDQM

TGA Australia

COFEPRIS Mexico

KOREAN FDA

WHO-GMP India

US DMF USFDA

CEP / ASMF EDQM*

TGA Australia

COFEPRIS Mexico

KOREAN FDA

WHO-GMP India

*Application Filed

US DMF USFDA

CEP / ASMF EDQM*

WHO-GMP India

*Application Filed

US DMF USFDA

CEP / ASMF EDQM

WHO-GMP India

US DMF USFDA

CEP / ASMF EDQM*

WHO-GMP India

*Application Filed

US DMF USFDA

CEP / ASMF EDQM*

WHO-GMP India

*Application Filed

US DMF USFDA

CEP / ASMF EDQM

WHO-GMP India

Regulatory Filings In 2023 – 24

Glycopyrronium Bromide

Mirabegron

Pipeline Products

Articaine HCl

Tetracaine Base/HCl

APIs

(UNIT 2)

Steroids

Grade – IP/BP/EP/USP

WHO-GMP/GMP – Approved

Written Confirmation – Received

CEP – Applied

JDMF/AFM No. – 230MF10161

Korea

Grade – IP/BP/EP/USP

WHO-GMP/GMP – Approved

Grade – IP/BP/EP/USP

WHO-GMP/GMP – Approved

Written Confirmation – Received

CEP – Applied

Grade – IP/BP/EP/USP

WHO-GMP/GMP – Approved

Written Confirmation – Applied

Grade – IP/BP/EP/USP

WHO-GMP/GMP – Approved

Written Confirmation – Received

Grade – IP/BP/EP/USP

WHO-GMP/GMP – Approved

Written Confirmation – Received

Grade – IH

WHO-GMP/GMP – Approved

Hormones

Grade – IP/BP/EP/USP

WHO-GMP/GMP – Approved

Written Confirmation – Received

Grade – BP/EP/USP

WHO-GMP/GMP – approved

written confirmation – Received

Grade – BP/EP/USP

WHO-GMP/GMP – approved

written confirmation – Received

Grade – IP/IH

WHO-GMP/GMP – approved

written confirmation – Received

Grade – IP/BP/EP/USP

WHO-GMP/GMP – approved

written confirmation – Received

Grade – IP/BP/EP/USP

WHO-GMP/GMP – approved

written confirmation – Received

Grade – BP/EP

WHO-GMP/GMP – approved

written confirmation – Received

Grade – BP/EP/USP

WHO-GMP/GMP – approved

written confirmation – Received

Grade – BP/EP/USP

WHO-GMP/GMP – approved

written confirmation – Received

Grade – IP/BP/EP

WHO-GMP/GMP – Approved

Written Confirmation – Received

Grade – BP/EP

GMP – Approved

Written Confirmation – 2023-24

Pipeline Products

Clascoterone

Fluticasone Propionate

Difluprednate

Budesonide

Dydrogesterone

APIs

(UNIT 3)

Human Segment

Pentosan Polysulfate Sodium Capsules 100mg

Pentosan Polysulfate sodium Intravesical instillation

Melatonin prolonged release tablet 2mg

Pipeline Products

Glycopyrrolate 1mg tablet

Glycopyrrolate 2mg tablet

Glycopyrrolate oral solution 1mg/5ml

Pentosan Polysulfate Sodium gel 1.5%

Pentosan Polysulfate Sodium 0.1% cream

Pentosan Polysulfate Sodium 0.5% cream

Pentosan Polysulfate Sodium 1% + Triamcinolone Acetonide + Lidocaine ointment 2%

Pentosan Polysulfate Sodium capsules 45mg

Pentosan Polysulfate Sodium injection 90mg/ml

Pentosan Polysulfate Sodium capsules 45mg

Pentosan Polysulfate Sodium 100mg/ml – 6ml vial

Pentosan Polysulfate Sodium tablet 25mg

Melatonin tablet 1mg/2mg/3mg/5mg

Melatonin prolonged-release tablet 5mg

Phenytoin cream 0.1%

Lidocaine injection 2%

Lidocaine gel 2%

Phenytoin tablet 100mg

Phenytoin injection 50mg/ml

Granisetron Tablet 2mg

Granisetron Injection 1mg/m

Urology Products

Finasteride tablet 5mg

Tamsulosin tablet 0.4mg

Dutasteride soft gelatin capsules 0.5mg

Pipeline Products

Dutasteride + Tamsulosin capsules

Silodosin 4mg Capsules

Silodosin 8mg Capsules

Mirabegron extended-release tablets 25mg

Mirabegron extended-release tablets 50mg

Tamsulosin HCL Modified Release Capsules 0.2mg

Tamsulosin HCL Modified Release Capsules 0.4mg

Dutasteride + Tamsulosin + Tadalafil

Dutasteride + Alfuzosin + Tadalafil

Tolterodine tablet 1mg/2mg

OTC Ready Products

NANO-DECA

NANO-DECA PME

Ignite Capsules / Tablets

Varico Gel 30gm (Fagus Sylvatica extract 30gm)

Spento Q10 (Japanese origin Co-enzyme Q10 50mg)

Sweat Relief (Vida Lavan w/v)

Sleep Ready (Melatonin 5mg)

Chaga Mushroom

Revive Gel

Nonoxynol gel

Glycopyrrolate roll on

Filtrum

Veterinary Division

Pentosan Polysulfate Sodium Injection 250mg/ml

Pentosan Polysulfate Sodium Injection 100mg/ml

Pipeline Products

Pentorse Galaxy