Alkaloida Chemical Company Zrt | DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Alkaloida Chemical Company Zrt
USDMF

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

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Sharp is a leader in commercial packaging, clinical services, and sterile manufacturing.

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pharmacompass-1-m-2026-04-20

As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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Trusted Global CDMO Partner Delivering End-to-End Pharma Manufacturing & Development Solutions.

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pharmacompass-2-m-2026-04-20

Alkaloida Chemical Company Zrt

VIRTUAL BOOTH, Contact Details

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

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow

ACTIVE PHARMA INGREDIENTS

17 All APIs, 8 USDMF, 10 CEP/COS, 4 KDMF, 2 NDC API

17 All APIs
8 USDMF
10 CEP/COS
4 KDMF
2 NDC API

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

INSPECTIONS & REGISTRATIONS

6 FDA, 1 GDUFA, 2 Third-Party Audit

6 FDA
1 GDUFA
2 Third-Party Audit

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8 All

01 1BUSPIRONE BASE

02 1BUSPIRONE HYDROCHLORIDE

03 1HYDROXYCHLOROQUINE SULFATE

04 1HYDROXYCHLOROQUINE SULFATE USP

05 1MEXILETINE HYDROCHLORIDE USP BULK

06 1PHENOBARBITAL SODIUM, USP

07 1PHENOBARBITAL USP

08 1TOPIRAMATE

filter Holder Reset all filters

8 All

01 1ALKALOIDA CHEMICAL CO LTD

02 6ALKALOIDA CHEMICAL CO ZRT

03 1ICN HUNGARY COMPANY LTD

filter Country Reset all filters

8 All

01 7Hungary

02 1India

filter Status Reset all filters

8 All

01 3Active

02 5Inactive

filter GDUFA DMF Review Reset all filters

8 All

01 2Complete

02 6Blank

List of Suppliers

Supplier Virtual Booth

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01

Buspirone Base

RDD

Not Confirmed

Buspirone Base

RDD

Not Confirmed

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Alkaloida Chemical Company Zrt

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12135

Submission : 1996-09-16

Status : Inactive

Type : II

Product
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02

Buspirone Hydrochloride

RDD

Not Confirmed

Buspirone Hydrochloride

RDD

Not Confirmed

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Digital Content

Alkaloida Chemical Company Zrt

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12172

Submission : 1996-10-16

Status : Inactive

Type : II

Product
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03

Hydroxychloroquine Sulfate

RDD

Not Confirmed

Hydroxychloroquine Sulfate

RDD

Not Confirmed

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Digital Content

Alkaloida Chemical Company Zrt

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 12762

Submission : 1997-11-12

Status : Inactive

Type : II

Product
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04

Hydroxychloroquine Sulfate Usp

RDD

Not Confirmed

Hydroxychloroquine Sulfate Usp

RDD

Not Confirmed

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Digital Content

Alkaloida Chemical Company Zrt

GDUFA

DMF Review : Complete

Rev. Date : 2018-05-11

Pay. Date : 2018-04-04

DMF Number : 23582

Submission : 2010-03-25

Status : Active

Type : II

Product
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05

Mexiletine Hydrochloride Usp Bulk

RDD

Not Confirmed

Mexiletine Hydrochloride Usp Bulk

RDD

Not Confirmed

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Digital Content

Alkaloida Chemical Company Zrt

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 10376

Submission : 1993-07-26

Status : Inactive

Type : II

Product
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06

Phenobarbital Sodium, Usp

RDD

Not Confirmed

Phenobarbital Sodium, Usp

RDD

Not Confirmed

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Digital Content

Alkaloida Chemical Company Zrt

GDUFA

DMF Review : Complete

Rev. Date : 2020-03-31

Pay. Date : 2020-03-06

DMF Number : 34598

Submission : 2020-03-10

Status : Active

Type : II

Product
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07

Phenobarbital Usp

RDD

Not Confirmed

Phenobarbital Usp

RDD

Not Confirmed

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Digital Content

Alkaloida Chemical Company Zrt

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 4642

Submission : 1982-09-01

Status : Active

Type : II

Product
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08

Topiramate

RDD

Not Confirmed

Topiramate

RDD

Not Confirmed

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Digital Content

Alkaloida Chemical Company Zrt

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16405

Submission : 2003-01-30

Status : Inactive

Type : II

Product
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Contact Alkaloida Chemical Company Zrt and get a quotation

Alkaloida Chemical Company Zrt is a supplier offers 16 products (APIs, Excipients or Intermediates).

Find Phenobarbital bulk with DMF, CEP offered by Alkaloida Chemical Company Zrt

Find Phenobarbital Sodium bulk with DMF, CEP offered by Alkaloida Chemical Company Zrt

Find Codeine bulk with CEP offered by Alkaloida Chemical Company Zrt

Find Codeine Phosphate bulk with CEP offered by Alkaloida Chemical Company Zrt

Find Dihydrocodeine Hydrogen Tartrate bulk with CEP offered by Alkaloida Chemical Company Zrt

Find Hydroxychloroquine Sulphate bulk with DMF offered by Alkaloida Chemical Company Zrt

Find Noscapine bulk with CEP offered by Alkaloida Chemical Company Zrt

Find Noscapine Hydrochloride bulk with CEP offered by Alkaloida Chemical Company Zrt

Find Pholcodine bulk with CEP offered by Alkaloida Chemical Company Zrt

Find Buspirone bulk offered by Alkaloida Chemical Company Zrt

Find Buspirone Hydrochloride bulk offered by Alkaloida Chemical Company Zrt

Find Hydroxychloroquine Sulphate bulk offered by Alkaloida Chemical Company Zrt

Find Mexiletine bulk offered by Alkaloida Chemical Company Zrt

Find Oxycodone Hydrochloride bulk offered by Alkaloida Chemical Company Zrt

Find Topiramate bulk offered by Alkaloida Chemical Company Zrt

Find Dihydrocodeine Hydrogen Tartrate bulk offered by Alkaloida Chemical Company Zrt

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