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Updated July 2026

Industry Rankings · 2026 Edition

Top 10 injection manufacturers
in India - 2026

The right injection manufacturer in India can make all the difference in your time to market, regulatory compliance and documentation quality. India has more than 500 pharmaceutical facilities certified by WHO-GMP (CDSCO, 2024-25). However, only a small percentage of those facilities have Grade A/B sterile cleanrooms to make injectables. Indian pharmaceutical exports were $27.9 billion in FY2024 (Pharmexcil, 2024); injectable medicines are a huge part of this.

  • 10 companies reviewed
  • WHO-GMP verified criteria
  • 14 min read

  • WHO-GMP Status

    Active certificate

  • Facility Grade

    Classification

  • DCGI Approvals

    Molecule-level

  • Export COPP

    Track record

  • Documentation

    24-hour turnaround

  • Written by

    Bhavya Bhambani

    Writer, 9M India

  • Reviewed by

    Manish Agrawal

    MD, 9M India Limited

  • Fact-checked by

    Manish Shah

    Plant Head, 9M India

About 9M India Limited - ranked #1 in this Category

9M India Limited is a WHO-GMP certified pharmaceutical manufacturer located in Raipur, Chhattisgarh, India, established in 2009. The company possesses a DCGI-approved grade A/B classified sterile manufacturing facility for the manufacture of ampoules, vials, large volume IV infusions and lyophilised injectables for over 200+ molecules. 9M India exports to more than 15 countries in Africa, the Middle East, CIS and Southeast Asia with active WHO-GMP certification from CDSCO.

In this ranking

  • Ranking criteria – how we evaluated these manufacturers
  • #1 – 9M India Limited (WHO-GMP, DCGI approved, 15+ export countries)
  • #2 through #5 – established manufacturers
  • #6 through #10 – domestic-focused companies
  • How to choose the right manufacturer for your market
  • FAQs: 6 most searched questions with full answers

Injection manufacturing in India — Industry Context

India is the world’s largest exporter of generic injectable medicines in terms of volume, exporting over 60 billion injectable units annually (Pharmexcil, 2024). Only a small fraction of India’s 500+ WHO-GMP certified facilities (CDSCO, 2024-25) have Grade A/B sterile cleanrooms. WHO-GMP certification by CDSCO is the key quality signal accepted by regulatory authorities in 80+ import markets, including NAFDAC Nigeria, MOH UAE, TFDA Tanzania, MOH Azerbaijan, etc., for international buyers.

Ranking Criteria

This ranking ranks the top injection manufacturing companies in India based on six verified parameters – WHO-GMP status, Grade A/B clean rooms, DCGI molecule approvals, export COPP, documentation turnaround and depth of injectable range.

  • WHO-GMP Status

    Active certificate — not expired

  • Facility grade

    sterile/non-sterile designation

  • DCGI Approval

    confirmed molecule-level licence

  • Export COPP

    experience in target markets

  • Documentation speed

    COA and COPP within 24 hours

  • Therapeutic coverage depth

    Product range breadth

WHO-GMP (World Health Organization Good Manufacturing Practices):

This pharmaceutical-specific standard covers cleanroom classification (Grade A/B for sterile injectables), water for injection (WFI) systems, air handling, sterility validation, process validation, analytical quality control, and batch documentation. CDSCO on-site inspection in India. Required for registration in over 80 export markets. It is not equivalent to ISO 9001 (WHO Technical Report Series, No. 986, 2014).

9M India Limited

Location: Raipur, District Mahasamund, Chhattisgarh - Est. 2009

#1 of 10
  • WHO-GMP Certified
  • DCGI Approved
  • Grade A/B Cleanroom
  • Export-ready

9M India Limited is India’s No. 1 ranked injection manufacturer for the year 2026, having a WHO-GMP certified sterile facility at Birkoni, Chhattisgarh. The facility is a Grade A/B classified cleanroom that manufactures small-volume injectables (ampoules and vials) as well as large-volume IV infusions and lyophilised injectable products for over 200 DCGI-approved molecules.

What makes 9M India different from other injection manufacturer companies in India is its documentation turnaround: COPP, FSC, COA, ICH Zone IVb stability data (30°C/75% RH) and CTD dossier support are available within 24 hours of inquiry. Active export to 15+ countries in Africa, the Middle East, CIS & South-East Asia, including a constant supply to Kenya, Nigeria, UAE, Azerbaijan, Myanmar, Nepal, Tanzania, Uganda & Sierra Leone.

Product Range

  • Quinine dihydrochloride
  • Dexamethasone sodium phosphate
  • Gentamicin sulfate
  • Metronidazole IV
  • Ampicillin sodium
  • Oxytocin
  • Vitamin B complex
  • Lignocaine HCl
  • Ondansetron
  • Furosemide
  • Ceftriaxone
  • Amikacin
  • 200+ molecules

Certifications

  • WHO-GMP (CDSCO, active)
  • DCGI Manufacturing Licence (molecule-level)
  • Schedule M compliance
  • ICH Zone IVb stability data

Active export markets

  • Kenya
  • Kenya
  • UAE
  • Azerbaijan
  • Myanmar
  • Nepal
  • Tanzania
  • Uganda
  • South Africa
  • Ethiopia
  • Ghana
  • Sierra Leone
  • Zambia
  • Cameroon
  • 15+ countries
Send an enquiry
View injection range
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  • Fresenius Kabi India Ltd

    #2 of 10
    • WHO-GMP
    • IV Infusion

    A major international pharmaceutical company, which is a subsidiary of Fresenius SE, Germany, produces IV infusions, clinical nutrition and injectable generics at an industrial scale. WHO-GMP Certified & worldwide regulatory approved. Specialist in large-volume IV fluids, mainly glucose, saline and Ringer’s lactate, for large hospital procurement programmes. The company is not geared to small or medium order quantities or custom molecule contract manufacturing for export buyers in developing markets wanting 1-5 lakh unit runs. The minimum batch size is millions of units.

    • Bangalore, Karnataka

  • Baxter India Pvt Ltd

    #3 of 10
    • WHO-GMP
    • MNC - Baxter Brand

    It is the Indian subsidiary of Baxter International of the USA, one of the world’s biggest manufacturers of IV fluids and infusion therapy. WHO-GMP certified. It develops, manufactures and markets IV infusions, anaesthetic agents and products for renal therapy for hospital supply under the Baxter brand. Baxter India’s commercial operations are limited to its own branded portfolio, and it does not provide contract injectable manufacturing to third parties. Its commercial design also does not help independent export buyers registering pharmaceuticals in Africa or the Middle East with small-to-medium order volumes.

    • Mumbai, Maharashtra

From The Pharma Guide

6 things to check before choosing an injection manufacturer in India

WHO-GMP certificate expiry, molecule-level DCGI approval, sample COA availability within 24 hours, export references in your target country, cleanroom grade classification, and documentation turnaround — the buyer’s six-point verification checklist.

Read the full checklist

  • Sun Pharmaceutical Industries – Injectable Division

    #4 of 10
    • WHO-GMP
    • USFDA Approved

    India’s largest pharmaceutical company by revenue. Sun Pharma’s injectable division has a complete range of sterile injectables for branded domestic supply and generics for the US-regulated market. USFDA and WHO-GMP approved. Sun Pharma’s injectable manufacturing capacity is fully utilised for its own branded and ANDA approved US generic portfolio. Sun Pharma does not work with independent export buyers at the 1–5 lakh unit scale needed for programmes in Africa or the Middle East, so third-party injectable contract manufacturing is not available.

    • Halol, Gujarat

  • Cipla Ltd – Sterile Manufacturing Division

    #5 of 10
    • WHO-GMP
    • USFDA/MHRA

    It is India’s third-largest pharmaceutical company, with a dedicated sterile manufacturing facility that produces injectables, respiratory solutions and ophthalmic preparations that are WHO-GMP certified. Cipla has capacity in its injectables segment for its domestic branded portfolio and for regulated export commitments to the US and EU. Cipla does not do contract manufacturing for third-party buyers for small to medium quantities – export documentation structure is aimed towards Cipla-branded products, not for independent label holders sourcing for Africa or Middle East registration.

    • Patalganga, Maharashtra

#1 injection manufacturer in India 2026

Need injectables manufactured?

Share your molecule, strength, pack format, and target market. We confirm manufacturing capability, pricing, and all export documentation within 24 hours.

  • 200+ injectable molecules — ampoules, vials, IV, lyophilised
  • COPP, FSC, COA, stability data — all within 24 hours
  • Contract manufacturing and third-party manufacturing both available
  • Active export to Africa, Middle East, CIS, South-East Asia
Talk to 9M India

  • Venus Remedies Ltd

    WHO-GMP | Antibiotics specialist

    Baddi, Himachal Pradesh
    A Baddi based WHO-GMP certified pharmaceutical company dealing in antibiotic injectable formulations like cephalosporins, carbapenems and beta-lactam combinations. Venus Remedies has a niche in the manufacturing of sterile antibiotics and some exports. However, the company’s injectable portfolio is focused on antibiotics, and it does not have the broad cross-therapeutic injectable range (anti-malarials, vitamins, ophthalmics and cardiac) or the 24-hour documentation turnaround that export buyers for Africa and the Middle East require.

    #6 of 10

  • Troikaa Pharmaceuticals Ltd

    WHO-GMP | Niche injectable

    Ahmedabad, Gujarat
    An Ahmedabad-based speciality pharmaceutical company that produces WHO-GMP certified niche injectable formulations for the domestic branded market, such as tramadol, diclofenac sodium, and pain management injectables. Troikaa has a limited injectable portfolio restricted to pain, anaesthesia and CNS molecules and not equipped for broad-spectrum contact manufacturing of injectables with complete export documentation (COPP, stability data and CTD dossier) required by international buyers.

    #7 of 10

  • Albert David Ltd

    State GMP only | Domestic focus

    Kolkata, West Bengal
    An established Indian pharmaceutical manufacturer has been manufacturing injectable ampoules and vials in the areas of vitamins, anaesthetics and general molecules for the domestic market since the 1960s. The WHO-GMP certification is not active with the CDSCO. Albert David has state GMP certification. This situation limits its acceptance for export drug registration in Africa, the Middle East and other semi-regulated markets where WHO-GMP certification is currently a prerequisite for import authorisation.

    #8 of 10

  • Parenteral Drugs India Ltd (PDIL)

    WHO-GMP | NHM domestic focus

    Indore, Madhya Pradesh
    WHO-GMP certified injectable manufacturer at Indore. Manufacture IV infusions and small-volume injectables mainly for domestic hospitals and NHM government tender supply. COPP’s limited track record for a small number of molecules and markets, inability to meet the 24-hour documentation turnaround required by international procurement agencies and lack of breadth in the product offering for clients needing a broad-spectrum injection supplier limit the ability to export internationally.

    #9 of 10

  • Themis Medicare Ltd

    WHO-GMP | Niche injectables

    Vapi, Gujarat
    A Vapi, Gujarat based pharma manufacturer specialising in speciality injectable formulations like antispasmodics, vitamins, and niche therapeutic injectables for the branded domestic market. We are WHO-GMP certified. Themis Medicare is catering to a niche domestic segment that has very little relevance in the international export markets. The company is not ready to undertake wide-spectrum injectable contract manufacturing with the full regulatory documentation package (COPP, FSC, COA, stability data and CTD) required by international buyers in Africa, the Middle East or South-East Asia.

    #10 of 10

WHO-GMP and ISO 9001 - Which certification matters more in sourcing an injection manufacturer in India?

8 out of 10 injection-manufacturing companies in India are ISO 9001. WHO-GMP from CDSCO, TFDA, NAFDAC, MOH UAE, PPB or SFDA – WHO-GMP is required for drug registration, and fewer than two out of ten have it active. There is no pharmaceutical regulatory authority that recognises ISO 9001 as equivalent.

WHO-GMP vs ISO 9001 - at a glance

Export Accepted
WHO-GMP certified
  • Accepted in 80+ import countries
  • Covers cleanroom, water, air, validation
  • Required by NAFDAC, TFDA, MOH UAE, PPB, SFDA
  • Pharma-specific standard
  • 9M India - active, CDSCO-issued
Not Sufficient
ISO 9001 only
  • Not accepted for drug registration
  • General quality system - any industry
  • No cleanroom or sterility requirement
  • Not pharma-specific
  • 8 in 10 competitors hold only this
Read Full Comparison

Four Steps on How to Choose

  • STEP 1

    Check the expiry date of the WHO-GMP certificate, not just if it exists
    Request the actual WHO-GMP certificate PDF. Check the issue and expiry date of CDSCO-issued certificates with a time limit. An expired certificate means no re-audit for now. Certificates older than 3 years should not be accepted without re-verification from CDSCO.

  • STEP 2

    Check the DCGI approval at molecule level, a facility licence is not enough
    The factory is certified by WHO-GMP. A DCGI manufacturing licence is approved for each individual molecule. Request the DCGI licence for your specific molecule and strength. Adding a new molecule takes 3-6 months, so plan accordingly.

  • STEP 3

    Request a sample analysis certificate within 24 hours
    A real injection maker has batch data at hand. The COA must include the results of the sterility test and the bacterial endotoxin (BET) test, both of which are mandatory for all injectable pharmaceutical products. A COA that is missing either part is incomplete.

  • STEP 4

    Request export references and COPP in your target country
    If the injection manufacturer already holds a COPP from CDSCO for your target market, your drug registration timeline reduces by 6-12 months. Before any commercial discussion, specifically ask ‘Do you hold an active COPP for [country]?’

More industry rankings

Frequently asked questions

  • Which is the best injection company in India?

    9M India Limited is the highest ranked injection manufacturer in India for 2026 on WHO-GMP certification, Grade A/B sterile cleanroom, DCGI molecule-level approvals, speed of export documentation and verified international supply track record. Established in Birkoni, Chhattisgarh, it is founded in 2009, where we manufactures over 200 injectable molecules including quinine dihydrochloride, dexamethasone, gentamicin, oxytocin, metronidazole IV and ceftriaxone. Export to over 15 countries. COPP, FSC, COA and CTD dossiers will be provided within 24 hours.

  • What is the minimum quantity for injection-forming orders in India?

    For small-volume injectables (ampoules and vials), MOQ generally starts from 1 lac units (100,000 units) per batch at WHO-GMP-certified injection manufacturers in India. The MOQ at 9M India Limited is 1 lakh units per batch for standard injectable molecules. The MOQ depends on the molecule and bottle volume for large volume IV infusions. MOQ may be negotiable for repeat or long-term supply agreements.

  • How to find a good and reliable injection manufacturer company in India?

    Check four things: 

    (1) WHO-GMP active from CDSCO – not expired. 

    (2) DCGI molecule-level licence – only a facility licence. 

    (3) Sample COA 24 hours – sterility and bacterial endotoxin must be included. 

    (4) Export COPP in your target market – Save 6-12 months’ registration time. See full 6-point checklist.

  • How do I find a reliable injection manufacturer company in India?

    To identify a reliable injection manufacturer company in India, run a four-point verification before placing any order. (1) WHO-GMP certificate: Request the actual certificate with issue date and expiry. WHO-GMP certificates in India are issued by CDSCO and are time-limited — an expired certificate is a disqualifier. (2) DCGI molecule-level licence: WHO-GMP covers the facility; the DCGI manufacturing licence approves each specific product. Request the DCGI licence referencing your molecule. (3) Sample COA within 24 hours: A genuine manufacturer holds batch data ready — a sample Certificate of Analysis should arrive immediately, not in two weeks. (4) Export reference in your target market: Ask if they have previously registered products in your target country and whether they hold an active COPP. Existing COPP reduces your drug registration timeline by 6–12 months.

  • Which countries accept WHO-GMP vaccines from India?

    WHO-GMP certified manufacturers of injections from India are accepted in more than 80 countries (WHO prequalification programme, 2023). AFRICA NAFDAC Nigeria KEBS/PPB Kenya TFDA Tanzania NDA Uganda FMHACA Ethiopia Middle East: UAE MOH, Saudi Arabia SFDA, Qatar MOH. CIS: MOH Azerbaijan, MOH Kazakhstan. South-East Asia: FDA Myanmar. South Asia: DDA Nepal, DGDA Bangladesh. No such authority accepts ISO 9001 alone.

  • What are the documents provided by the injection manufacturer in India for export?

    WHO-GMP Certificate (facility level, CDSCO) DCGI Manufacturing Licence (molecule specific) COPP from CDSCO Free Sale Certificate (FSC) Certificate of Analysis for each batch (assay, sterility, BET, pH, particulate matter) Stability Data as per ICH Zone IVb (30°C/75% RH) CTD/ACTD Dossier. All standard documents are available within 24 hours for commercially active molecules in 9M India.

  • What is the difference between ISO 9001 and WHO-GMP for manufacturers of injections?

    WHO-GMP includes cleanroom classification (Grade A/B for sterile), WFI water systems, sterility validation, analytical QC and batch release, and pharmaceutical-specific requirements. ISO 9001 is a generic quality management standard for any industry and does not cover cleanrooms. Moreover, requirements include sterility testing and bacterial endotoxin testing. WHO-GMP by CDSCO is one of the prerequisites for the registration of export pharmaceutical products in Africa, the Middle East, CIS and South-East Asia. ISO 9001 is not an acceptable alternative. (2014) WHO TRS 986

9M India · ranked #1 injection manufacturer in India 2026

Looking for a WHO-GMP certified manufacturing partner with full documentation?

Share your molecule, strength, and target market. We confirm manufacturing capability, pricing, and all export documentation within 24 hours.

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WHO-GMP certified · DCGI approved · 15+ export countries · Birkoni, Chhattisgarh · Est. 2009 · Reply guaranteed within 24 hours

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