Progene Pharma

Product category

Human pharmaceutical formulations, made to your specification

Finished medicines in every common dosage form, from tablets and capsules to injections and IV fluids. Choose from our range of generics or send us your own formula. Progene Pharma manufactures it in a WHO-GMP certified facility, under your brand, with the documents to register it in your country.

Dosage forms
Tablets to IV fluids
Therapy areas
15 and more
Standards
BP, USP, Ph. Eur., IP
Dossiers
CTD and ACTD

What are human formulations?

A human formulation is a finished medicine for people: the active ingredient made into a dose a patient can take, such as a tablet, a capsule, a syrup or an injection, then packed and labelled for sale. It is the product a distributor registers and sells, as opposed to the raw active ingredient (API).

Progene Pharma supplies generic formulations to importers, distributors, hospitals and tender suppliers outside India. Most are prescription medicines, made to the same pharmacopoeia standards as the originals and registered under your brand or ours.

  1. 01

    From our range

    Generics we already make, in standard strengths and pack sizes. The quickest way to start, with documents ready for most products.

  2. 02

    Under your brand

    Private label (also called third-party or contract manufacturing): any medicine in our range, with your name, artwork and pack size.

  3. 03

    To your formula

    A product we do not list yet: a new strength, a combination, a different dosage form, or a copy of a reference product you name. We develop it, test it and make it.

Dosage forms we manufacture

Each dosage form is manufactured in a facility approved for it, so sterile products such as injections and eye drops are made in dedicated sterile areas.

  • Tablets

    Uncoated, film-coated, enteric-coated, dispersible, chewable, effervescent, sustained-release and bilayer

  • Capsules

    Hard gelatin, vegetarian (HPMC) and soft gelatin

  • Oral liquids

    Syrups, suspensions, solutions and paediatric drops

  • Dry syrups and sachets

    Powder for oral suspension, granules and sachets, mixed with water before use

  • Injections

    Liquid ampoules and vials, and dry powder for injection

  • IV fluids

    Sodium chloride, dextrose, Ringer lactate and other large-volume infusions

  • Creams and ointments

    Creams, ointments, gels and lotions for the skin

  • Drops and sprays

    Eye, ear and nasal drops, and nasal sprays

  • Inhalation

    Respules and nebuliser solutions

Therapy areas

These are examples, not a limit. If a medicine is approved in your country, we can make it. Download the product list (PDF)

Quality you can register

Regulators judge a medicine by where it is made, how it is tested and how it holds up on the shelf.

  • Certified facility

    Progene Pharma manufactures every product in a WHO-GMP certified facility, also certified to EU-GMP and ISO, matched to the standard your regulator accepts. What each standard means

  • Pharmacopoeia specifications

    Made and tested to the British (BP), United States (USP), European (Ph. Eur.) or Indian (IP) Pharmacopoeia, whichever your registration names.

  • Tested before release

    Raw materials and every finished batch are tested in the quality control laboratory, and each batch ships with its Certificate of Analysis.

  • Built for your climate

    Stability studies to ICH conditions, including the hot, humid conditions of Zone IVb, so shelf life holds up in tropical markets.

Documents for registration

Prepared in the format your regulator expects and sent before the first shipment, so you can register the product while it is being made.

  • Certificate of Analysis (COA)

    With every batch, showing test results against the specification

  • Certificate of Pharmaceutical Product (COPP)

    In the WHO format, issued by the Indian regulator for registration abroad

  • Registration dossier

    In CTD format, or ACTD for ASEAN countries, with stability data

  • GMP certificate

    A copy of the manufacturing facility's certificate

  • Free Sale Certificate

    Where your regulator asks for proof the product can be sold

  • MSDS and samples

    Safety data sheets, and samples for registration testing

How ordering works

  1. 01

    Send your requirement

    The medicine, strength, dosage form, pack size, quantity and the country you are registering in.

  2. 02

    Quotation

    We confirm the price, the lead time, the certification and the documents your regulator expects.

  3. 03

    Registration

    We send the dossier, the COPP and samples so you can register the product, or we make your formula first if it is new.

  4. 04

    Manufacture and shipping

    Each batch is made, tested and released with a COA, then packed for export and shipped with the import documents.

Questions about human formulations

Something else? Email [email protected].

What are human pharmaceutical formulations?

They are finished medicines for people, such as tablets, capsules, syrups, injections and creams, made from an active ingredient and ready to be packed, registered and sold. They are different from APIs, which are the raw active ingredients.

Can you make a medicine that is not on your product list?

Yes. Progene Pharma does custom manufacturing, so we can make any human formulation that is approved in your country, including new strengths, combinations and dosage forms, or a copy of a reference product you name. Send us the details and we will confirm what is needed.

Which dosage forms can you manufacture?

Tablets of every common type, hard and soft gelatin capsules, syrups and suspensions, dry syrups and sachets, injections in ampoules and vials, IV fluids, creams and ointments, eye, ear and nasal drops, and respules.

Do you offer private label or third-party manufacturing for export?

Yes. Progene Pharma manufactures under your brand name, with your artwork, language and pack size, and supplies the documents to register the product in your country.

Which documents do you provide for product registration?

Progene Pharma provides a COA with every batch, a COPP in the WHO format, a registration dossier in CTD or ACTD format with stability data, a copy of the facility's GMP certificate, a Free Sale Certificate where required, MSDS, and samples for registration testing.

Which pharmacopoeia standards do you follow?

Progene Pharma makes and tests each product to the pharmacopoeia your registration names: British (BP), United States (USP), European (Ph. Eur.) or Indian (IP).

What is the minimum order quantity?

It depends on the product, the dosage form and the packaging. We work with large importers and tender suppliers as well as smaller distributors, and confirm the minimum quantity with your quotation.

Do you sell these medicines in India?

No. Progene Pharma supplies distributors and importers outside India. Our products are for export only.

Explore more

Request a quote

Send us your product requirements and target country. Our team will reply with a quotation and next steps.

Email
[email protected]
Phone
+91 22 49793146
WhatsApp
+91 90829 70494
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