Active Pharmaceutical Ingredients

Macsen Labs has been manufacturing Active Pharmaceutical Ingredients since 1952.

We manufacture niche and rare to find API molecules. We specialize in manufacturing injectable pharmaceutical dyes and are the only manufacturer in the world having a complete range of pharmaceutical application dyes. Our API manufacturing is done in compliance with cGMP as per guidelines of WHO, ICH & FDA. We have state of art facilities with fully qualified equipment and validated utilities. The final stages of manufacturing are done in classified clean rooms. We have a very strong team for Quality Assurance, Regulatory Compliance and Quality Control. Our top management includes technocrats and scientists who are deeply involved technically in this business. We have a state of the art R&D setup with a highly qualified team and latest equipment like LC-MS/MS, GC-MS/MS, etc, which gives us the ability to synthesize complex organic molecules in a short timeframe. We have a dedicated team for technology transfer of process from R&D to Pilot Scale and from Pilot scale to Plant scale. Our Grams to Tons production capacity can cater to new drug innovators from clinical studies till launch of the drug.
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State of the art R & D Set up
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US FDA Registered
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WHO GMP certified
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EU Written Confirmations from CDSCO
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Complete documentation support like DMF, Tech Pack, Process Validations, Analytical Method Validations, Stability Studies, Degradation Studies, Drug Characterization, etc.
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Can manufacture in batch sizes ranging from grams to Kgs in reactor volumes of 5-5000 ltrs.
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Open for facility audits by customer and international regulatory bodies
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Capability to develop complex and difficult to synthesize APIs

Diagnostics & Ophthalmic

DISODIUM EOSINE FRP X (EOSIN Y)

17372-87-1

Diagnostic agent

GMP, DMF - Available

FLUORESCEIN SODIUM USP/BP / Ph Eur

518-47-8

Used in ophthalmology & bioimaging

USDMF, WHO GMP - Available

INDIGO CARMINE - USP

860-22-0

Diagnostic dye for renal tests

DMF, WHO GMP - Available

INDOCYANINE GREEN

3599-32-4

Diagnostic dye used in Angiography

GMP - Available

TRYPAN BLUE

72-57-1

Ophthalmic dye used for surgery

GMP - Available

INDOCYANINE GREEN (IODINE FREE)

3599-32-4

Diagnostic dye in ophthalmology

GMP - Available

BRILLIANT BLUE - G

6104-58-1

Ophthalmic dye used for surgery

(Currently Under Scale Up)

ISOSULFAN BLUE

68238-36-8

Used in Lymphography

(Currently Under Development)

Antiseptics & Antimicrobials

ACRIFLAVINIUM CHLORIDE BP/ E.P 5.0

8048-52-0

Antiseptic used in aquaculture

GMP, DMF - Available

ACRIFLAVINE HYDROCHLORIDE BPC 63

8063-24-9

Antiseptic used in aquaculture

GMP, DMF - Available

ACRIFLAVINE NEUTRAL BPC 49/ NF X
(EUFLAVINE)

8048-52-0

Antiseptic used in aquaculture

GMP, DMF - Available

AMYLMETACRESOL

1300-94-3

Antiseptic used in mouth & throat infections

(Currently Under Development)

COLLOIDAL SILVER

9007-35-6

Antimicrobial & Antibacterial agent

(Currently Under Development)

CRYSTAL VIOLET BP/
METHYLROSANILINIUM CHLORIDE BP

548-62-9

Antiseptic used in fungal & bacterial infections

GMP, DMF - Available

GENTIAN VIOLET USP

548-62-9

Antiseptic used in fungal & bacterial infections

GMP, DMF - Available

MERBROMIN N.F XII

129-16-8

Antiseptic used for burns & wounds

GMP, DMF - Available

MERCUROCHROME BPC

129-16-8

Antiseptic used for burns & wounds

GMP, DMF - Available

NITROXOLINE

4008-48-4

Antibacterial used to treat biofilm infections

GMP, DMF - Available

PROFLAVINE HEMISULPHATE BP / IP

1811-28-5

Antiseptic used in wound dressings

GMP, DMF - Available

SILVER NITRATE USP/IP/BP

7761-88-8

Topical Antiseptic

GMP, DMF - Available

SILVER SULFADIAZINE USP

22199-08-2

Antiseptic used for burns & wounds

USDMF, EU-WC, WHO GMP - Available

Antidotes & Metal Chelators

METHYLENE BLUE USP/BP 1973/BP 2000

122965-43-9

Antidote for methemoglobinemia

USDMF, EU-WC, WHO GMP - Available

METHYLTHIONINIUM CHLORIDE BP/E.P-9.0/E.P-10

122965-43-9

Antidote for methemoglobinemia

USDMF, EU-WC, WHO GMP - Available

DEFERIPRONE

30652-11-0

Iron chelator used in Thalassemia

GMP - Available

PRUSSIAN BLUE

14038-43-8

Antidote for heavy metal poisoning

(Currently Under Development)

Antifungal

SELENIUM SULFIDE USP

518-47-8

Antifungal used to treat dandruff

USDMF, WHO GMP - Available

CICLOPIROX OLAMINE

41621-49-2

Antifungal used for skin infections

(Currently Under Development)

Supplements for Mineral Deficiency

SELENIOUS ACID - USP

7783-00-8

Used to treat selenium deficiency

DMF, WHO GMP - Available

SELENIUM DIOXIDE MONOHYDRATE IP

7783-00-8

Used to treat selenium deficiency

GMP - Available

SODIUM SELENITE

10102-18-8

Used to treat selenium deficiency

GMP - Available

L-METHYLFOLATE CALCIUM

151533-22-1

Used to treat folate deficiency

(Currently Under Development)

Anti-Psychotic

VILOXAZINE HYDROCHLORIDE

35604-67-2

Used to treat ADHD

(Currently Under Scale Up)

Cardiovascular

NICORANDIL

65141-46-0

Vasodilator used to treat Angina

(Currently Under Scale Up)

Gastroenterology

PINAVERIUM BROMIDE

53251-94-8

Used to treat Irritable Bowel Syndrome (IBS)

(Currently Under Development)

QUINFAMIDE

62265-68-3

Used to treat Amoebiasis and Helminthiasis

(Currently Under Development)

Antitussive

BENZONATATE

104-31-4

Used to treat cough

(Currently Under Development)

Other APIs

LANTHANUM CARBONATE

587-26-8

Used to treat hyperphosphatemia

(Currently Under Scale Up)

METHYL NICOTINATE

93-60-7

Rubefacient used to treat muscle & joint pain

GMP-Available

MONOBENZONE USP

103-16-2

Depigmenting agent used to treat vitiligo

GMP-Available

SODIUM TETRADECYL SULFATE

1191-50-0

Sclerosing agent

(Currently Under Development)

DERQUANTEL

187865-22-1

Anthelmintic veterinary drug

(Currently Under Development)