Facility-2: ZAFA Hormones Division

ZAFA Hormones Division is a dedicated facility for the manufacture of Hormonal products. It has been built on latest WHO and cGMP guidelines and is one of the few dedicated facilities operating around the world.

This facility is built over an area of 17,000 square feet with additional Large Storage area for storage of materials

This facility is approved by the Federal Ministry of Health, Government of Pakistan. In addition to this it has also been inspected and approved by Mr.Bryan Hartley, Ex-Head of Inspection and Enforcement, MCA of the United Kingdom.

Mr. David Peary, Deputy High Commisioner of the United Kingdom and Major General(retired) Mohammad Aslam, the Director General Health, Government of Pakistan jointly inaugurated this facility.

Major General (Retired) M.Aslam Khan, Director General Health, Pakistan, appreciated the role that National Pharmaceutical companies are portraying by strengthening government hands in providing health care facilities to the people of Pakistan. He further said that "this relationship between ZAFA and the FUTURES Group, Europe, with the support of the Government of Pakistan and the Government of the United Kingdom is an excellent example of a successful relationship between public and private sector.

Mr. David Pearey, the Deputy High Commissioner of the United Kingdom in his address appreciated the efforts put by ZAFA in installations of this unit and said that "Pakistan has just entered the elite group of countries, able to ensure consumers that its own locally produced contraceptive pills are of the WORLD CLASS QUALITY."

Mr. Hartley played a vital role in the development of this unit and stressed upon the importance of a dedicated facility for hormonal Products. During his speech at the inauguration of this facility, Mr. Hartley commented that "this is the only plant of its kind in Pakistan and one of the few in the world that has been able to keep up with tough, new Quality Standards in the contraceptive pill production."

This facility has dedicated equipments for production, packaging and Quality Control. Our hiring criteria at this unit are as per latest guidelines. We are a socially responsible organization, thus not only the material waste is controlled through our Treatment plant but we also pay utmost importance to the air that is leaving our facility. HEPA filters is one of the systems that are used to ensure that the air leaving our facility is free from any hormonal content.

The capacity at this facility is of 33 million cycles of combined Oral Contraceptives that can be increased to 60 million cycles (single-shift basis) within a short span of 6 weeks. In addition the cpacity for manufacturing Emergency Contraceptives is around 1 million tablets per day. Our capacity for the manufacture of DMPA injections is around 2.5 million packas per annum (single-shift basis).

At ZAFA Hormones we are working on the latest cGMP guidelines and ensure consistency in our production results. Latest equipments are used to ensure content uniformity in tablets and this we ensure that every tablet has the quantity of the raw material as stated. In addition results between different batches are compared to ensure the minimum possible variation of results between batches.

In Pakistan, ZAFA is working in partnership with the FUTURES Group, a project funded initially by DFID (Department for International Development, Government of the United Kingdom) and now by DFID and USAID. Our partnership in Pakistan is for increasing the prevalence of Contraceptive products. ZAFA's relationship with the FUTURES Group is an ideal relationship that could be used for all Social Marketing projects worldwide. We are working on a Subsidy free basis whereby ZAFA manufactures and markets the products and FUTURE promote the usage of the product. Our relationship has been appreciated both at national and International levels and could be considered as an ideal relationship between Public/Private enterprise (by private enterprise we mean Commercial).

We are manufacturing and jointly marketing with the FUTURES Group our following three products:

  • FAMILA-28: A low dose Oral Contraceptive
  • EMKIT: Emergency Oral Contraceptive
  • FAMILA Injections: 3 months DMPA injections

According to an independent details survey ZAFA's FAMILA-28 has almost 70% of the Pakistani Contraceptive pill market share and we have a major presence in the contraceptive market with our other contraceptive products.

ZAFA was one of the first companies in the world to promote 2 pills at once regimen for its Emergency Contraceptive, EMKIT DS, as per latest World Health Organization (WHO) guidelines.

On request of the FUTURES Group, the National Research Institute for Fertility Care (NRIFC), an institute approved by WHO, carried out clinical trials for ZAFA's locally manufactured DMPA Injections, FAMILA INJECTIONS (ROXYPROG) and a major international DMPA injection and found it equally effective and we quote from their report "Pakistani women who participated in the trial found the same level of safety and efficacy from locally manufactured DMPA as with the imported DMPA". This further endorsed FUTURES confidenc for ZAFA's range of Hormonal products.

The Inspectors of both the Federal as well as the Provincial Minstries of Health inspect this facility at regular intervals. These inspections can be both informed as well as surprise.

In addition to the FUTURES Group in Pakistan ZAFA is also supplying low dose Oral Contraceptives (NOVODOL) and Emergency Contraceptives (ecp) to GreenStar Pakistan, a PSI Project.

The partnership with the FUTURES Group and GreenStar has brought ZAFA's retail share in Pakistan of Contraceptives to above 90%.

ZAFA Hormones is also honored as it supplies almost 100% requirements of the GAMBIAN Social Marketing Program.

Contraceptive and Hormonal products from this facility are also supplied to some African and South American Countries, including Peru and Sudan.

Our Hormone Unit is another step towards quality, economy, commitment and compliance of our mission statement which is to ensure the availbility of quality drugs at affordable prices throughout the country and the world.

Remarks by: Mr. Bryan Hartley

Based on the observations during manufacture of initial batches of Famila-28 tablet at the new facility of ZAFA Pharmaceutical Laboratories (Private) Limited Hormones Division, situated at A-46 S.I.T.E. Gulshan-e-Maymar, Super Highway Karachi, and the analytical results obtained at the various stages of manufacture, the above-mentioned facility is hereby being approved for manufacture of Famila-28 tablet. The premises here comply with the requirements of WHO guide to GMP and should satisfy European Standards.

I am fully satisfied with quality, validation process and results.

Bryan Hartley Ex-Head of Inspection and Enforcement
MCA of the United Kingdom.

January 21, 2002

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