---
title: CMC Regulatory Submission Support CDMOs in India
path: /services/cmc-regulatory-support/india
companies_count: 13
---

# CMC Regulatory Submission Support CDMOs in India

13 published CDMOs match CMC Regulatory Submission Support in India.

Locations in this set include India, United States, Italy, France, Germany, and United Kingdom.

Capabilities that show up most often in this set: Small Molecule, Biologics (Other), Biologics (Monoclonal Antibodies), Peptide, and Antibody-Drug Conjugate (ADC).

## Matching companies

- [Akums Drugs and Pharmaceuticals Ltd.](/companies/akums)
  - India's largest CDMO with 15+ state-of-the-art facilities and 30% domestic market share, manufacturing 4,100+ formulations across tablets, capsules, injectables, APIs, and specialty dosage forms under WHO-GMP, USFDA, EU-GMP, and TGA compliance.
- [Axplora](/companies/axplora)
  - Global CDMO and API manufacturer specializing in complex small molecule development, ADC manufacturing, HPAPIs, and hazardous chemistry across ten production sites in Europe, India, and the US.
- [Biocon](/companies/biocon)
  - Fully integrated biopharmaceutical company developing affordable biosimilars, generic formulations, and complex APIs for diabetes, cancer, and autoimmune diseases.
- [Curia](/companies/curiaglobal)
  - Global CDMO with 30+ years of experience offering integrated services across small molecule, generic APIs, sterile drug product, and biologics manufacturing, backed by 20+ facilities and 3,000+ professionals across North America, Europe, and India.
- [Divi's Laboratories](/companies/divislabs)
  - World's largest API manufacturer and trusted CDMO partner for 25+ years, offering generic APIs, custom synthesis, peptides, and nutraceutical ingredients to 100+ countries with complete backward integration and green chemistry principles.
- [Dr. Reddy's Laboratories](/companies/drreddys)
  - Integrated global pharmaceutical company manufacturing generics, APIs, biosimilars, and innovative medicines across 66 countries with capabilities in small molecule and biologics development and manufacturing.
- [Lupin Limited](/companies/lupin)
  - Global pharmaceutical manufacturer with robust quality systems aligned to US FDA, UK MHRA, and EU GMP standards; operates diversified manufacturing across generics, complex formulations, and specialty segments with advanced automation and digital quality infrastructure.
- [Neuland Laboratories](/companies/neulandlabs)
  - Global API CDMO supporting biotechnology and pharmaceutical companies in design, development, and manufacturing of complex active pharmaceutical ingredients from early-stage drug development through commercial scale.
- [Optimus Drugs Private Limited](/companies/optimuspharma)
  - Leading CDMO delivering end-to-end small molecule drug substance and drug product development and manufacturing from clinical to commercial scale, with 21+ years of expertise and GMP-certified facilities.
- [PI Health Sciences](/companies/pihealthsciences)
  - PI Health Sciences is an integrated CRDMO offering end-to-end drug discovery, development, and manufacturing services with R&D and manufacturing locations in Europe and India.
- [Sai Life Sciences](/companies/sailife)
  - Integrated CRDMO offering discovery, development, and manufacturing services for small molecule NCE programs across 280+ global pharma and biotech clients.
- [Syngene International](/companies/syngeneintl)
  - Innovation-led CRDMO offering integrated scientific services from early discovery through commercial manufacturing, with cGMP-compliant facilities, 5,200+ scientists, and a new 50,000-liter single-use bioreactor capacity in the U.S.
- [Winkem Labs Pvt. Ltd.](/companies/winkemlabs)
  - Contract development and manufacturing organization (CDMO) offering complex chemical synthesis, process development, API manufacturing, and supply services for pharmaceutical clients globally.