Kalintis Healthcare | DMFs | US Drug Master File (DMF) Details | Pharmacompass.com

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Kalintis Healthcare
USDMF

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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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-1-m-2026-04-20

PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

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Expand your portfolio with Egis- value-added generics, API capabilities, and reliable contract services to drive your growth.

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pharmacompass-2-m-2026-04-20

Kalintis Healthcare

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

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

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow

ACTIVE PHARMA INGREDIENTS

19 All APIs, 11 USDMF, 17 NDC API, 7 Listed APIs

19 All APIs
11 USDMF
17 NDC API
7 Listed APIs

INTERMEDIATES

12 ALL Intermediates

12 ALL Intermediates

INSPECTIONS & REGISTRATIONS

1 FDA

1 FDA

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filter Subject Reset all filters

11 All

01 1BENZTROPINE MESYLATE USP

02 1CEVIMELINE HYDROCHLORIDE USP

03 1DIPHENOXYLATE HYDROCHLORIDE

04 1DIPHENOXYLATE HYDROCHLORIDE USP + ATROPINE SULPHATE USP MIXTURE

05 1FUROSEMIDE USP

06 1LORAZEPAM USP

07 1METHENAMINE HIPPURATE USP

08 1METHIMAZOLE USP

09 1MEXILETINE HYDROCHLORIDE USP

10 1OXAZEPAM USP

11 1TORSEMIDE USP

filter Holder Reset all filters

11 All

01 3KALINTIS HEALTHCARE PRIVATE LTD

02 8KALINTIS HEALTHCARE PVT LTD

filter Country Reset all filters

11 All

01 10India

02 1U.S.A

filter Status Reset all filters

11 All

01 11Active

filter GDUFA DMF Review Reset all filters

11 All

01 9Complete

02 2Blank

List of Suppliers

Supplier Virtual Booth

price-trend

01

Benztropine Mesylate Usp

Bioprocess International Europe

Not Confirmed

Benztropine Mesylate Usp

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2020-08-21

Pay. Date : 2020-07-29

DMF Number : 34964

Submission : 2020-07-29

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

02

Cevimeline Hydrochloride Usp

Bioprocess International Europe

Not Confirmed

Cevimeline Hydrochloride Usp

Bioprocess International Europe

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2023-11-02

Pay. Date : 2023-09-20

DMF Number : 38880

Submission : 2023-09-25

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

03

Diphenoxylate Hydrochloride

Bioprocess International Europe

Not Confirmed

Diphenoxylate Hydrochloride

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2025-11-13

Pay. Date : 2025-09-24

DMF Number : 42698

Submission : 2025-09-30

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

04

Diphenoxylate Hydrochloride Usp + At...

Bioprocess International Europe

Not Confirmed

Diphenoxylate Hydrochloride Usp + At...

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40368

Submission : 2025-07-17

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

05

Furosemide Usp

Bioprocess International Europe

Not Confirmed

Furosemide Usp

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2018-08-29

Pay. Date : 2018-08-03

DMF Number : 33062

Submission : 2018-08-06

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

06

Lorazepam Usp

Bioprocess International Europe

Not Confirmed

Lorazepam Usp

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2021-01-29

Pay. Date : 2020-12-08

DMF Number : 35299

Submission : 2020-12-11

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

07

Methenamine Hippurate Usp

Bioprocess International Europe

Not Confirmed

Methenamine Hippurate Usp

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 40367

Submission : 2025-12-06

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

08

Methimazole Usp

Bioprocess International Europe

Not Confirmed

Methimazole Usp

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2025-02-18

Pay. Date : 2024-12-20

DMF Number : 40372

Submission : 2024-12-02

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

09

Mexiletine Hydrochloride Usp

Bioprocess International Europe

Not Confirmed

Mexiletine Hydrochloride Usp

Bioprocess International Europe

Not Confirmed

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Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-01

Pay. Date : 2020-09-21

DMF Number : 35146

Submission : 2020-09-23

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

10

Oxazepam Usp

Bioprocess International Europe

Not Confirmed

Oxazepam Usp

Bioprocess International Europe

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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Post an Enquiry

Digital Content

Kalintis Healthcare

GDUFA

DMF Review : Complete

Rev. Date : 2023-01-19

Pay. Date : 2022-11-30

DMF Number : 36730

Submission : 2022-12-10

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

1
2

Contact Kalintis Healthcare and get a quotation

Kalintis Healthcare is a supplier offers 18 products (APIs, Excipients or Intermediates).

Find Benztropine bulk with DMF offered by Kalintis Healthcare

Find Cevimeline Hydrochloride bulk with DMF offered by Kalintis Healthcare

Find Diphenoxylate Hydrochloride bulk with DMF offered by Kalintis Healthcare

Find Furosemide bulk with DMF offered by Kalintis Healthcare

Find Lorazepam bulk with DMF offered by Kalintis Healthcare

Find Methenamine Hippurate bulk with DMF offered by Kalintis Healthcare

Find Methimazole bulk with DMF offered by Kalintis Healthcare

Find Mexiletine bulk with DMF offered by Kalintis Healthcare

Find Oxazepam bulk with DMF offered by Kalintis Healthcare

Find Torsemide bulk with DMF offered by Kalintis Healthcare

Find Atropine Sulfate bulk offered by Kalintis Healthcare

Find Butalbital bulk offered by Kalintis Healthcare

Find Chlorpromazine Hydrochloride bulk offered by Kalintis Healthcare

Find Esomeprazole Magnesium bulk offered by Kalintis Healthcare

Find Ferric Carboxymaltose bulk offered by Kalintis Healthcare

Find Ketotifen Fumarate bulk offered by Kalintis Healthcare

Find Methylene Blue bulk offered by Kalintis Healthcare

Find Phenobarbital bulk offered by Kalintis Healthcare

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