Contract Manufacturing

Responsible Partner For Your Growth Journey

Axxelent Manufacturing Facility is located in the Special Economic Zone in Sri City,Tada, Andhra Pradesh. One of the biggest advantages of SEZ is it allows importation of raw materials without paying duty tariffs.

We offer our partners

  • Development to Commercial Manufacturing support
  • Technical support for transfer of Products developed/manufactured at other locations
  • Clinical Supplies

Our Phase-1 Manufacturing set-up is for Oral Solid Dosage Forms targeted to be commissioned by Dec 2022 and then exported to countries like the United States.

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DOSAGE FORM MANUFACTURING CAPABILITIES

“We offer Contract Manufacturing services to our partners for Oral Solid Dosage forms. (The facility is under construction and Phase 1 is operational by Dec 2022 and Phase 2 by July 2023)

  • Axxelent Manufacturing Facility is designed to support supplies of Products to meet Regulations of CDSCO, India; USFDA;UK MHRA;AU TGA; PMDA ; WHO and other Regulatory Agencies
  • Located in SEZ – benefit on imports for exports
  • Convenient access (90 kms) from Axxelent R&D Center, Chennai International Airport and Sea Port
  • Phase 1 for Oral Solid Dosage Forms – Tablets (Immediate Release, Modified Release and Bi-Layer), Hard Gel Capsules (Powder and Pellets) and Dried Granules
  • Can handle Products that require low humidity such as Effervescent Tablets, Mositure and Light sensitive molecules etc
  • Facility is capable for manufacturing and supply of Clinical samples, Small to Large Scale Commercial as per respective regulations
  • Manufacturing Facility offers flexibility in various batch sizes from Exhibit batches to Small and Large Scale Commercial requirements
  • Facility designed with Individual men and material entry with dedicated HVAC to support OEL 3 classification/colored Products
  • Temperature controlled warehouse for Raw Materials which includes 2-8 degree C storage condition

Oral Liquids

  • Capable of Manufacturing clear Solutions, Syrups, and Suspensions.
  • Batch size ranging from 500 Litres to 2,000 Litres.
  • Filling line can handle PET and Glass bottles from 30 mL to 480 mL.
  • The capacity of line will be 7.2 million bottles per annum.

Semi-Solids

  • Capable of Manufacturing Ointments, Creams and Gels.
  • Batch size ranging from 100 kgs to 500 kgs.
  • Filling line can handle Alu & Lami Tubes from 10 gm to 200gm.
  • The capacity of line will be 10 million tubes per annum.

Phase-I Facility equipped with following capabilities :

  • Cold/Hot Blistering Packaging
  • Bottle Packaging (Dry powder in bottles & Tablets/Capsules in bottles)
  • Bulk Container Packaging for repacking
  • Sachet Packing for Dried Granules and Pellets
  • Clinical supplies kits

Packaging equipped with Auto Cartoner and Track and Trace system.

We also provide stand alone Contract Packaging services

Construction of our Injectable Manufacturing Facility is planned in Phase II of our Operations.

Till our Injectable Manufacturing Facility becomes operational, we can provide the following turnkey services without having to deal with multiple partners in order to meet project timelines.

  • cGMP Site Coordination: Identification/Selection/Evaluation of an Appropriate CMO for Pilot and Pivotal Batches manufacturing. Axxelent has contacts and can coordinate with Indian FDA or EU approved sites to qualify for executing the Pilot BE batches.
  • Execution of Process Optimization / Pilot BE Batches Manufacturing at CMO site
  • Validation Batch execution support at CMO site
  • Clinical CRO Co-ordination: Identification/Selection/Evaluation of an appropriate CRO for carrying our Bioequivalence Studies, wherever applicable

Oral Solids

"We offer Contract Manufacturing services to our partners for Oral Solid Dosage forms. (The facility is under construction and Phase 1 is operational by Dec 2022 and Phase 2 by July 2023)

  • Axxelent Manufacturing Facility is designed to support supplies of Products to meet Regulations of CDSCO, India; USFDA;UK MHRA;AU TGA; PMDA ; WHO and other Regulatory Agencies
  • Located in SEZ – benefit on imports for exports
  • Convenient access (90 kms) from Axxelent R&D Center, Chennai International Airport and Sea Port
  • Phase 1 for Oral Solid Dosage Forms – Tablets (Immediate Release, Modified Release and Bi-Layer), Hard Gel Capsules (Powder and Pellets) and Dried Granules
  • Can handle Products that require low humidity such as Effervescent Tablets, Mositure and Light sensitive molecules etc
  • Facility is capable for manufacturing and supply of Clinical samples, Small to Large Scale Commercial as per respective regulations
  • Manufacturing Facility offers flexibility in various batch sizes from Exhibit batches to Small and Large Scale Commercial requirements
  • Facility designed with Individual men and material entry with dedicated HVAC to support OEL 3 classification/colored Products
  • Temperature controlled warehouse for for Raw Materials which includes 2-8 degree C storage condition

ORAL LIQUIDS AND SEMI-SOLIDS

Oral Liquids

  • Capable of Manufacturing clear Solutions, Syrups, and Suspensions.
  • Batch size ranging from 500 Litres to 2,000 Litres.
  • Filling line can handle PET and Glass bottles from 30 mL to 480 mL.
  • The capacity of line will be 7.2 million bottles per annum.

Semi-Solids

  • Capable of Manufacturing Ointments, Creams and Gels.
  • Batch size ranging from 100 kgs to 500 kgs.
  • Filling line can handle Alu & Lami Tubes from 10 gm to 200gm.
  • The capacity of line will be 10 million tubes per annum.

Packaging Capabilities

Phase-I Facility equipped with following capabilities :

  • Cold/Hot Blistering Packaging
  • Bottle Packaging (Dry powder in bottles & Tablets/Capsules in bottles)
  • Bulk Container Packaging for repacking
  • Sachet Packing for Dried Granules and Pellets
  • Clinical supplies kits

Packaging equipped with Auto Cartoner and Track and Trace system.

We also provide stand alone Contract Packaging services

Injectables

Construction of our Injectable Manufacturing Facility is planned in Phase II of our Operations.

Till our Injectable Manufacturing Facility becomes operational, we can provide the following turnkey services without having to deal with multiple partners in order to meet project timelines.

  • cGMP Site Coordination: Identification/Selection/Evaluation of an Appropriate CMO for Pilot and Pivotal Batches manufacturing. Axxelent has contacts and can coordinate with Indian FDA or EU approved sites to qualify for executing the Pilot BE batches.
  • Execution of Process Optimization / Pilot BE Batches Manufacturing at CMO site
  • Validation Batch execution support at CMO site
  • Clinical CRO Co-ordination: Identification/Selection/Evaluation of an appropriate CRO for carrying our Bioequivalence Studies, wherever applicable

Careers

Be a part of a skilled and a fun to work with team.

Contact Us

We are here to help and answer any questions you might have.

Useful Links

Services

R&D Center

Axxelent Pharma Science Pvt. Ltd., Module No.1, 10th Floor A Block, IIT Madras Research Park, Kanagam Road, Taramani, Chennai-600113.
Tamil Nadu, India.

Call Us On : +91-44-61727900

Email Us : info@axxelent.com

Manufacturing Site

SEZ UNIT No.910, Portia Road, Sri City, Tirupati District, Andhra Pradesh, 517646.
Andhra Pradesh, India.

Call Us On : +91 8576 691100

Email Us : info@axxelent.com

Corporate Address

3 Jagadeeswaran Street T.Nagar
Chennai-600017, India.

Call Us On : 044-69127900

Email Us : info@axxelent.com

Expansion of Phase 2 Manufacturing for Small Volume Parenteral“Axxelent R&D unit received Recognition letter & Registration Certificate from DSIR, Ministry of Science and Technology, Govt. of India”