FDA APPLICATION 76560 | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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LGM Pharma

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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

LGM Pharma

VIRTUAL BOOTH, Contact Details

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

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2025, Corporate Presentation, Tailored Analytical Testing and Stability Services, Five Reasons to Outsource API Procurement

Product List 2025
Corporate Presentation
Tailored Analytical Testing and Stability Services
Five Reasons to Outsource API Procurement

VIDEO(s)

Challenges with Sourcing Pharmaceutical APIs, DCAT Member Company Announcement Forum, Regulatory Considerations for API Sourcing, Risk Mitigation for Supply Chain Challenges, Sourcing Concerns for Smaller Pharma Companies, Supply Chain Logistics Trends, Value of Finding a Capacity Match Early On

Challenges with Sourcing Pharmaceutical APIs
DCAT Member Company Announcement Forum
Regulatory Considerations for API Sourcing
Risk Mitigation for Supply Chain Challenges
Sourcing Concerns for Smaller Pharma Companies
Supply Chain Logistics Trends
Value of Finding a Capacity Match Early On

DIGITAL CONTENT

2 Interview #SpeakPharma, 11 Corporate Content #SupplierSpotlight, 2 Data Compilation #PharmaFlow, 19 News #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

583 All APIs, 583 Listed APIs

583 All APIs
583 Listed APIs

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

17 FDF Dossiers, 17 FDA Orange Book

17 FDF Dossiers
17 FDA Orange Book

KEY PRODUCTS

Beta Nicotinamide Adenine Dinucleotide, Bupropion Hydrobromide, Bupropion Hydrochloride, Doxorubicin Hydrochloride, Ketamine Hydrochloride, Lidocaine, Lidocaine Hydrochloride, Naltrexone, Naltrexone Hydrochloride, Naltrexone Methobromide, Pilocarpine Hydrochloride, Polidocanol, Salcaprozate Sodium, Sirolimus, Sodium Tetradecyl Sulfate, Sucralfate, Tesamorelin Acetate, Topiramate, Trastuzumab, Trastuzumab Emtansine

Beta Nicotinamide Adenine Dinucleotide
Bupropion Hydrobromide
Bupropion Hydrochloride
Doxorubicin Hydrochloride
Ketamine Hydrochloride
Lidocaine
Lidocaine Hydrochloride
Naltrexone
Naltrexone Hydrochloride
Naltrexone Methobromide
Pilocarpine Hydrochloride
Polidocanol
Salcaprozate Sodium
Sirolimus
Sodium Tetradecyl Sulfate
Sucralfate
Tesamorelin Acetate
Topiramate
Trastuzumab
Trastuzumab Emtansine

SERVICES

Drug Product Manufacturing, Analytical, API & Drug Product Development

Drug Product Manufacturing
Analytical
- 2 Analytical Testing Services
API & Drug Product Development
- 7 Formulation Development

KEY SERVICES

Capsule Contract Manufacturing, Contract Manufacturing for Tablets, Coated Tablet Manufacturing, Controlled Substance Tablets, ODT Contract Manufacturing, Immediate & Controlled Release Tablets, Extended Release Tablet Manufacturing, Sustained Release Tablet Manufacturing

Capsule Contract Manufacturing
Contract Manufacturing for Tablets
Coated Tablet Manufacturing
Controlled Substance Tablets
ODT Contract Manufacturing
Immediate & Controlled Release Tablets
Extended Release Tablet Manufacturing
Sustained Release Tablet Manufacturing

INSPECTIONS & REGISTRATIONS

40 FDA, 1 GDUFA

40 FDA
1 GDUFA

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01 2LGM PHARMA

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01 2CAPSULE;ORAL

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01 2BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

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01 2No

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Brand Name : BUTALBITAL, ACETAMIN...

The Lexington Hotel

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Digital Content

RLD : No

TE Code : AB

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Dosage Form : CAPSULE; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 325MG;50MG;40MG;30MG

Approval Date : 2004-06-10

Application Number : 76560

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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02

Brand Name : BUTALBITAL, ACETAMIN...

The Lexington Hotel

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

Contact Supplier

Digital Content

RLD : No

TE Code : AB

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Dosage Form : CAPSULE; ORAL

Proprietary Name : BUTALBITAL, ACETAMINOPHE...

Dosage Strength : 300MG;50MG;40MG;30MG

Approval Date : 2012-07-19

Application Number : 76560

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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Disclaimers
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.