Allergy & Respiratory
Antihistaminic
USP / EP / IP
Active pharmaceutical ingredients
Deep chemistry.
A global API platform.
Explore Morepen APIs by therapeutic area, then connect with our team on the molecule, specification and documentation your program needs.
Chemistry-led Process development & scale-upRegulatory depth DMFs, CEPs & technical documentationManufacturing scale 614 KL installed API / CDMO reactor capacity
The API collection
Explore the portfolio.
Search directly or refine by therapeutic area. Current forms, specifications, filing status and commercial availability are confirmed program by program.
Search the API collection
A compact discovery layer for Morepen's published small-molecule API portfolio.
Allergy & Respiratory
Antihistaminic
USP / EP / BP / ICH
Allergy & Respiratory
Antihistaminic
USP / EP / JP / IP
Allergy & Respiratory
Anti-asthmatic
USP / EP / ICH / JP / IP
Cardiovascular
Anti-lipemic
Crystalline trihydrate+1 form
Cardiovascular
Anti-lipemic
Crystalline+1 form
Cardiovascular
Anti-hypertensive
USP / EP / JP / IP
Diabetes
Anti-diabetic
Monohydrate+1 form
Diabetes
Anti-diabetic
Hydrochloride+1 form
Published portfolio reference. The production website should replace this link with the latest approved controlled API list. Applicable patent and territory restrictions remain relevant.
Documentation & portfolio support
Beyond individual APIs.
Morepen's API platform also includes dossier support, combinations, intermediates and market-specific regulatory packages that support customer development and market-entry programs.
Dossiers
Selected finished-dose dossiers in eCTD format to support customer product launches and documentation continuity.
Combinations
Published combinations around established API families, supporting broader development discussions.
Key intermediates
Intermediate chemistry supporting selected API programs, subject to patent, market and supply conditions.
Regulatory packages
Market-specific DMFs, CEPs and technical packages across regulated and international markets.
Need the complete published portfolio?
Open the complete API product list, then contact the API team to confirm current specifications, documentation, territory and supply availability.
Manufacturing & R&D backbone
Knowledge behind
every requirement.
API performance depends on process understanding, analytical control, regulatory documentation and dependable plant execution.
01
Process R&D
Route development, impurity understanding, process improvement and technology transfer.
02
Analytical development
Methods, stability, characterisation and documentation connected to the intended market.
03
Commercial manufacturing
Baddi and Masulkhana provide the manufacturing base for API and CDMO execution.
Quality & regulatory compliance
Global trust is earned
through repeatable systems.
Quality, data integrity, regulatory readiness and continuity of supply are central to long-term pharmaceutical partnerships.
Four consecutive USFDA inspections reported with Nil Form 483 observations
MASULKHANA / 17 APRIL 2026
A site-specific quality milestone.
The April 2026 inspection at the Masulkhana API facility concluded without Form 483 observations. Morepen's wider regulatory footprint includes engagement across multiple regulated markets, with scope varying by site, product and filing.
Read the inspection disclosure
Let us discuss your API requirement.
Share the molecule, intended market and broad supply requirements. Do not send confidential chemistry until a suitable agreement is in place.