FDA APPLICATION 72319 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Evonik Health Care is the innovation hub for leading life science companies

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Aarti Pharmalabs is a partner of choice for pharmaceutical companies for APIs & Intermediates. Largest Indian producer of Caffeine.

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Axplora is your partner of choice for complex APIs.

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Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

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pharmacompass-2-2026-02-09

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VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2025, Corporate Presentation, Revolutionary Dry Ice Shipping for APIs Below -70°C, Revolutionizing API Production with AI and Machine Learning, Ozonolysis in Flow, GMP Certificate 2024

Product List 2025
Corporate Presentation
Revolutionary Dry Ice Shipping for APIs Below -70°C
Revolutionizing API Production with AI and Machine Learning
Ozonolysis in Flow
GMP Certificate 2024

VIDEO(s)

API Development, Introducing the new TAPI, Oligonucleotides Development, Regulatory Affairs Services, Sterilization Services

API Development
Introducing the new TAPI
Oligonucleotides Development
Regulatory Affairs Services
Sterilization Services

DIGITAL CONTENT

1 Interview #SpeakPharma, 11 Corporate Content #SupplierSpotlight, 2 Data Compilation #PharmaFlow, 70 News #PharmaBuzz

1 Interview #SpeakPharma
11 Corporate Content #SupplierSpotlight
2 Data Compilation #PharmaFlow
70 News #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

528 All APIs, 357 USDMF, 164 CEP/COS, 41 JDMF, 39 EU WC, 26 KDMF, 78 NDC API, 302 Listed APIs

528 All APIs
357 USDMF
164 CEP/COS
41 JDMF
39 EU WC
26 KDMF
78 NDC API
302 Listed APIs

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 2 FDA Orange Book

2 FDF Dossiers
2 FDA Orange Book

SERVICES

Analytical, API Manufacturing, API & Drug Product Development

Analytical
- 1 Analytical Method Development
API Manufacturing
API & Drug Product Development
- 2 Preformulation & Material Science
- 10 API Development

KEY SERVICES

CDMO for Peptides, CDMO for Steroid Manufacturing, Contract Manufacturing for HPAPIs, HPAPI CDMO

CDMO for Peptides
CDMO for Steroid Manufacturing
Contract Manufacturing for HPAPIs
HPAPI CDMO

EXCIPIENTS

1 All Excipients, 1 NDC API

1 All Excipients
1 NDC API

INSPECTIONS & REGISTRATIONS

43 FDA, 3 EDQM, 5 GDUFA, 4 Third-Party Audit

43 FDA
3 EDQM
5 GDUFA
4 Third-Party Audit

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filter Applicant Reset all filters

1 All

01 1GOLDLINE

filter Dosage Reset all filters

1 All

01 1FOR SUSPENSION;ORAL

filter Regulatory Info Reset all filters

1 All

01 1DISCN

filter Brand Name Reset all filters

1 All

01 1GLYCOPREP

filter RLD Reset all filters

1 All

01 1No

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Brand Name : GLYCOPREP

Lotte New York Palace

TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Digital Content

RLD : No

TE Code :

POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS

TAPI Technology & API Services

Dosage Form : FOR SUSPENSION; ORAL

Proprietary Name : GLYCOPREP

Dosage Strength : 236GM/BOT;2.97GM/BOT;6.7...

Approval Date : 1988-12-23

Application Number : 72319

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.