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Updated July 2026

Industry Rankings · 2026 Edition

Top 10 Eye Drop Manufacturers in India 2026

Eye drops are sterile pharmaceutical products and need the same environment of cleanroom Grade A/B as injectable medicines. Eye drop manufacturers in India export ophthalmic formulations to the Middle East, CIS, Africa and South-East Asia. The most valuable export categories are anti-glaucoma and antibiotic eye drops (Pharmexcil, 2024). The right manufacturer must be determined to have WHO-GMP sterile ophthalmic capability.

  • 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

    Content 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, a WHO-GMP certified pharmaceutical manufacturer, is based at Raipur, Chhattisgarh. The company has a Grade A/B sterile manufacturing facility which manufactures ophthalmic eye drops across 100+ molecules, including antibiotic, anti-glaucoma, anti-inflammatory, antifungal, lubricant and fixed-dose combination eye drops. Active private label programme in ophthalmology for Azerbaijan and other CIS markets, with full documentation available 24 hours a day.

Eye Drop Manufacturer in India – Industry Context

India’s ophthalmic pharmaceutical exports in FY2024 were at around $450 million (Pharmexcil estimate, 2024). The Indian eye drop manufacturers supply anti-glaucoma, antibiotic, antifungal and lubricant ophthalmic preparations to the Middle East, CIS, Africa and South East Asia. The eye drops are manufactured by WHO-GMP certified companies. Anti-glaucoma eye drops (latanoprost, bimatoprost, dorzolamide and timolol) and antibiotic eye drops (ofloxacin, moxifloxacin and ciprofloxacin) are the most valuable segments of ophthalmic exports.

Ranking Criteria

This ranking is based on six criteria that are WHO-GMP status, Grade A/B sterile ophthalmic facility, WFI water system, DCGI approvals, anti-glaucoma and antifungal range, export documentation and COPP track record.

  • WHO-GMP status

    Valid and Unexpired

  • Facility grade

    Sterile/non-sterile designation

  • DCGI Approvals

    Confirmed molecule-level licence

  • Export COPP

    Experience in target markets

  • Documentation Speed

    COA and COPP within 24 hours

  • Therapeutic coverage depth

    Product Range Breadth

9M India Limited

Location: Raipur, Chhattisgarh — Est. 2009

#1 of 10
  • WHO-GMP Certified
  • Grade A/B Sterile
  • Anti-glaucoma range
  • Export-ready

With a WHO-GMP certified Grade A/B sterile facility committed to the manufacturing of ophthalmic formulations, 9M India Limited is striving to become the top eye drop manufacturer in India by 2026. DCGI has licensed more than 100 molecules of eye drops for use as anti-glaucoma, antibiotic, antifungal, anti-inflammatory and lubricant agents.

9M India’s ophthalmic programme has active private-label supply for dorzolamide + timolol and other antiglaucoma molecules in Azerbaijan. It is one of the few Indian manufacturers with a proven track record of exporting ophthalmic products to the CIS. We will send you the full documentation within 24 hours. Indian eye drop manufacturer with a Grade A filling area and WFI water system.

Product range

  • Ofloxacin 0.3%
  • Ciprofloxacin 0.3%
  • Moxifloxacin 0.5%
  • Tobramycin 0.3%
  • Bimatoprost 0.03%
  • Latanoprost 0.005%
  • Dorzolamide 2%
  • Timolol 0.5%
  • Dorzolamide+Timolol
  • Natamycin 5%
  • Cyclosporine 0.05%
  • Diclofenac sodium 0.1%
  • CMC lubricant
  • 100+ molecules

Certifications

  • WHO-GMP (CDSCO)
  • DCGI Manufacturing Licence
  • Grade A/B sterile ophthalmic filling zone
  • WFI water system
  • ICH Zone IVb stability data

Active export markets

  • Azerbaijan
  • Kenya
  • UAE
  • Nigeria
  • Myanmar
  • Nepal
  • Tanzania
  • 15+ countries
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  • Sun Pharma Advanced Research Company (SPARC) / Sun Ophthalmics

    #2 of 10
    • WHO-GMP + USFDA
    • own brand only

    Sun Pharma’s ophthalmic divisparties orion manufactures a wide range of prescription and OTC eye drops including antibiotic, anti-glaucoma, anti-inflammatory and lubricant, in WHO-GMP and USFDA-approved facilities. Sun Ophthalmics is one of the biggest manufacturers of ophthalmic formulations in India. However, Sun Pharma’s ophthalmic manufacturing is restricted to its own branded portfolio of generics for the domestic and US markets. They do not contract manufacture eye drops for third parties or for the independent buyer’s brands.

    • Ankleshwar, Gujarat

  • Cipla Ltd – Ophthalmic Division

    #3 of 10
    • WHO-GMP + USFDA
    • Cipla brand

    Goa
    Cipla’s ophthalmic division manufactures antiglaucoma, antibiotic and anti-inflammatory eye drops in WHO-GMP and USFDA approved facilities. Specialist in ophthalmic products for the Cipla brand in India and select overseas markets. Cipla’s eye drop capacity is for its own branded portfolio. It does not do third-party contract ophthalmic manufacturing for independent export buyers.

    • Goa

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

  • Entod Pharmaceuticals Ltd

    #4 of 10
    • WHO-GMP
    • Ophthalmic specialist

    Mumbai-based ophthalmic pharmaceutical company engaged in the manufacturing of prescription and OTC eye drops including antibiotic, anti-glaucoma, anti-inflammatory and dry eye formulations. WHO-GMP certified sterile manufacturing unit. Entod Pharmaceuticals has initiated its export operations in a few markets. However, the company is focused on selling its own branded product portfolio (Entod brand) and not as a contract ophthalmic manufacturer to third-party export buyers with full COPP/CTD documentation support.

    • Mumbai, Maharashtra

  • Aurolab (Aravind Eye Hospital Group)

    #5 of 10
    • WHO-GMP
    • Social sector

    Aurolab, the manufacturing arm of the globally renowned Aravind Eye Hospital Group, produces ophthalmic formulations, IOLs, viscoelastics, sutures, and eye drops under WHO-GMP certification, primarily for the social sector, NGO procurement, and institutional supply at subsidised prices. The mission of Aurolab is to provide affordable, high-quality eye care products to healthcare programmes in the developing world. It is not intended to be a commercial contract manufacturer for independent export buyers who require branded label manufacturing and full drug registration documentation.

    • Madurai, Tamil Nadu

#1 EYE DROP MANUFACTURER IN INDIA 2026

Need eye drops manufactured?

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  • 100+ ophthalmic molecules — antibiotic, anti-glaucoma, antifungal, lubricant
  • Grade A/B sterile facility with validated WFI water system
  • COPP, FSC, COA and ICH stability data — all within 24 hours
  • Active export to Azerbaijan, CIS, Africa and the Middle East
Talk to 9M India

  • Ajanta Pharma Ltd – Ophthalmics

    WHO-GMP | domestic brand

    Mumbai, Maharashtra
    A medium sized pharmaceutical company with WHO-GMP certified ophthalmic manufacturing (lubricant, antibiotic and anti-inflammatory eye drops) mainly for export markets and domestic branded sales under the Ajanta brand. Ajanta exports eye care products to Africa and select emerging markets. However, it is a branded generic company and not a contract eye care manufacturer. Small to medium quantities with no third-party production under buyer brands.

    #6 of 10

  • Pacific Ophthalmics

    WHO-GMP | Domestic focus

    Solan, Himachal Pradesh
    The company is an ophthalmic pharmaceutical company based in Solan, Himachal Pradesh with a focus on producing antibiotic and lubricating eye drops for sale in the Indian domestic market. WHO-GMP certified. Pacific Ophthalmics has a limited export documentation infrastructure, a limited COPP track record, CTD dossier support and ICH Zone IVb stability data availability. It is not well-positioned for major international export markets that require full regulatory documentation packages at this time.

    #7 of 10

  • Jawa Pharmaceuticals Pvt Ltd

    WHO-GMP | small domestic

    Delhi NCR
    They are a small ophthalmic pharmaceutical manufacturer based in Delhi NCR. We manufacture antibiotic and lubricant eye drops We are certified under WHO-GMP for domestic supply to hospitals and pharmacies. Limited export activity. Documentation infrastructure for international drug registration (eg, COPP, CTD dossiers, ICH stability data) is not developed to the level required by international procurement agencies in African, Middle Eastern or CIS markets.

    #8 of 10

  • FDC Limited – Ophthalmic

    WHO-GMP | Domestic brand

    Sinnar, Maharashtra
    Domestic branded sales of lubricant, antibiotic and anti-inflammatory eye drops under the FDC brand (Neozen, Locula, etc.) from a mid-sized pharmaceutical company with WHO-GMP certified ophthalmic manufacturing. FDC does have some exports, but its eye-care products are not its biggest revenue source. Ophthalmic contract manufacturing for independent buyer brands is not a core business, and it is outsourced.

    #9 of 10

  • Micro Labs Ltd – Ophthalmics

    WHO-GMP | domestic brand

    Bangalore, Karnataka
    A mid-sized pharmaceutical company supplies lubricant and antibiotic eye drops for domestic branded sales under the Micro Labs brand. Ophthalmic manufacturing is WHO-GMP certified. Lack of export documentation infrastructure and record of COPP in international markets. They are not a contract manufacturer of glasses for foreign customers.

    #10 of 10

WHO-GMP & ISO 9001 for Eye Drop Manufacturer in India

What type of certification determines eligibility for export Sterile ophthalmic eye drops are manufactured in Grade A/B cleanroom environments similar to those used for sterile injectable products. WHO-GMP from CDSCO is mandatory for the registration of drugs in all major pharmaceutical import markets. ISO 9001 is not acceptable for the registration of eye drops for export. 

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

  • Check Grade A/B sterile cleanroom - ask for the classification certificate

    The same as sterile injectable manufacturing, eye drops require a Grade A aseptic filling zone with a Grade B background. Ask the manufacturer directly: ‘What is the cleanroom grade of your ophthalmic filling area? The correct answer is a Grade A background with Grade B.

  • Check WFI (Water for Injection) system for ophthalmic water

    The aqueous ophthalmic preparation for manufacturing sterile eye drops needs Water for Injection (WFI)-quality water. The use of purified water instead of WFI by manufacturers does not conform to the WHO-GMP requirements for sterile ophthalmic products, and this is a serious deficiency.

  • Request COA with sterility and particulate matter results

    The COA for eye drops must display the pH within the ophthalmic tolerance range (6.5–7.5 for most formulations), subvisible particulate matter counts, and sterility test results (pass/fail according to pharmacopoeia). Bacterial Endotoxins Testing of Aqueous Ophthalmic Preparations

  • Acquire COPP for eye-care products in your target country

    Export drug registration of eye drops in Africa, the Middle East and the CIS requires a COPP from CDSCO. In some markets, anti-glaucoma molecules may have further controlled substance import requirements; check with your target country’s regulatory authority.

More industry rankings

Frequently asked questions

  • Which is the best eyedrop company in India?

    9M India Limited aspires to be India’s top eye drop manufacturer in 2026. We believe in our capabilities, which include our WHO-GMP Grade A/B sterile ophthalmic facility, DCGI approvals, anti-glaucoma and antifungal range, export documentation and verified CIS and Africa export track record. Manufactures 100+ ophthalmic molecules, including Ofloxacin, Moxifloxacin, Bimatoprost, Latanoprost, Dorzolamide+Timolol, Natamycin 5% antifungal and Cyclosporine. Azerbaijan eyes active supply. Documentation within 24 hours.

  • What are the sterile manufacturing requirements for eye drop manufacturers in India?

    Eye drops are sterile preparations falling under Schedule M of Drugs and Cosmetics Rules, 1945. WHO-GMP requirements: Grade A aseptic filling zone, Grade B background, WFI quality water, verified container closure integrity, sterility testing for each batch, visible and subvisible particulate matter testing, pH testing, and, if necessary, bacterial endotoxin testing. (WHO TRS No. 986, 2015)

  • What is the minimum quantity to order for eyedrop manufacturing in India?

    The MOQ for standard multi-dose ophthalmic formulations is 50,000 units per batch from manufacturers of eye drops with WHO-GMP certification in India. 9M India Limited has a MOQ of 50,000 units per batch. Unit-dose (preservative-free) Blow-fill-seal packaging may have a higher MOQ. Contact 9M India for molecule-specific MOQs in 24 hours.

  • Which eye drop molecules are most exported from India?

    Most common exported ophthalmic molecules from India: Antibiotics such as Ofloxacin 0.3%, Ciprofloxacin 0.3%, Moxifloxacin 0.5%, Tobramycin 0.3%, and Gentamicin 0.3%; anti-glaucoma drugs such as Latanoprost 0.005%, Bimatoprost 0.5%, Dorzolamide 2%, and the Dorzolamide+Timolol combination. Antifungal Natamycin 5% is used for fungal keratitis. Anti-inflammatories include diclofenac sodium 0.1% and prednisolone acetate 1%. Lubricants are carboxymethyl cellulose (CMC) and sodium hyaluronate.

  • What documents does an eyedrop manufacturer provide for export?

    WHO-GMP Certificate (CDSCO, sterile ophthalmic scope), DCGI Manufacturing Licence (specific to ophthalmic molecules), CDSCO COPP Free Sale Certificate, COA per batch (sterility, particulate matter, pH, assay, preservative content), Stability Data under ICH Zone IVb (30°C/75% RH), Container Closure Integrity Test data, CTD/ACTD Dossier. 9M India has all documents available in 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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